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The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company.</span></p>\n<p><span style="font-weight: 400;">PDUFA was passed in the U.S. in 1992, which allows the FDA to collect fees from the sponsor company to fund the review process.</span></p>\n<p><span style="font-weight: 400;">A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional clinical studies to establish the efficacy and/or safety of the treatment option, problems with chemistry, manufacturing and controls, etc.</span></p>\n<p><span style="font-weight: 400;">A delay in the review period may stem from the FDA needs additional time to review any additional data/information that may have been tabled subsequent to the submission of the regulatory application or the FDA’s inability to complete site inspections where the drug ingredients are being made etc.</span></p>\n<p><span style="font-weight: 400;">The FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based on the data of filing the regulatory application. If the company doesn’t provide a timeline either, it is left to the investors to do the calculations.</span></p>\n"},"name":"What is an FDA PDUFA date?"},{"@type":"Question","acceptedAnswer":{"@type":"Answer","text":"<p><span style="font-weight: 400;">A regulatory application (NDA, sNDA, BLA, sBLA, etc.) is usually accepted for standard review or priority review. A standard review will mean the FDA has to hand out its verdict within 10 months of filing the application. The review window for a priority review gets shortened to six months.</span></p>\n<p><span style="font-weight: 400;">Once a company files for a regulatory application, the FDA takes up to 60 days to respond with an ‘accepted for review’ or ‘refuse-to-file’ decision.</span></p>\n"},"name":"How long does an FDA approval take? "},{"@type":"Question","acceptedAnswer":{"@type":"Answer","text":"<p><span style="font-weight: 400;">A Catalysts Calendar is one way of tracking all the </span><span style="font-weight: 400;">decisions in a single place. Usually, the FDA puts out a release and/or communicates to the company, which in turn will issue a press release.</span></p>\n"},"name":"How do you find FDA approvals?"}]}</script><meta name="next-head-count" content="66"/><link as="font" crossorigin="anonymous" href="/next-assets/fonts/manrope-v15-latin/manrope-v15-latin-300.woff2" rel="preload" type="font/woff2"/><link as="font" crossorigin="anonymous" href="/next-assets/fonts/manrope-v15-latin/manrope-v15-latin-regular.woff2" rel="preload" type="font/woff2"/><link as="font" crossorigin="anonymous" href="/next-assets/fonts/manrope-v15-latin/manrope-v15-latin-500.woff2" rel="preload" type="font/woff2"/><link as="font" crossorigin="anonymous" href="/next-assets/fonts/manrope-v15-latin/manrope-v15-latin-600.woff2" rel="preload" type="font/woff2"/><link as="font" crossorigin="anonymous" href="/next-assets/fonts/manrope-v15-latin/manrope-v15-latin-700.woff2" rel="preload" type="font/woff2"/><link as="font" crossorigin="anonymous" 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.fa-spin-reverse { --fa-animation-direction: reverse; } .fa-pulse, .fa-spin-pulse { -webkit-animation-name: fa-spin; animation-name: fa-spin; -webkit-animation-direction: var(--fa-animation-direction, normal); animation-direction: var(--fa-animation-direction, normal); -webkit-animation-duration: var(--fa-animation-duration, 1s); animation-duration: var(--fa-animation-duration, 1s); -webkit-animation-iteration-count: var(--fa-animation-iteration-count, infinite); animation-iteration-count: var(--fa-animation-iteration-count, infinite); -webkit-animation-timing-function: var(--fa-animation-timing, steps(8)); animation-timing-function: var(--fa-animation-timing, steps(8)); } @media (prefers-reduced-motion: reduce) { .fa-beat, .fa-bounce, .fa-fade, .fa-beat-fade, .fa-flip, .fa-pulse, .fa-shake, .fa-spin, .fa-spin-pulse { -webkit-animation-delay: -1ms; animation-delay: -1ms; -webkit-animation-duration: 1ms; animation-duration: 1ms; -webkit-animation-iteration-count: 1; animation-iteration-count: 1; -webkit-transition-delay: 0s; transition-delay: 0s; -webkit-transition-duration: 0s; transition-duration: 0s; } } @-webkit-keyframes fa-beat { 0%, 90% { -webkit-transform: scale(1); transform: scale(1); } 45% { -webkit-transform: scale(var(--fa-beat-scale, 1.25)); transform: scale(var(--fa-beat-scale, 1.25)); } } @keyframes fa-beat { 0%, 90% { -webkit-transform: scale(1); transform: scale(1); } 45% { -webkit-transform: scale(var(--fa-beat-scale, 1.25)); transform: scale(var(--fa-beat-scale, 1.25)); } } @-webkit-keyframes fa-bounce { 0% { -webkit-transform: scale(1, 1) translateY(0); transform: scale(1, 1) translateY(0); } 10% { -webkit-transform: scale(var(--fa-bounce-start-scale-x, 1.1), var(--fa-bounce-start-scale-y, 0.9)) translateY(0); transform: scale(var(--fa-bounce-start-scale-x, 1.1), var(--fa-bounce-start-scale-y, 0.9)) translateY(0); } 30% { -webkit-transform: scale(var(--fa-bounce-jump-scale-x, 0.9), var(--fa-bounce-jump-scale-y, 1.1)) translateY(var(--fa-bounce-height, -0.5em)); transform: scale(var(--fa-bounce-jump-scale-x, 0.9), var(--fa-bounce-jump-scale-y, 1.1)) translateY(var(--fa-bounce-height, -0.5em)); } 50% { -webkit-transform: scale(var(--fa-bounce-land-scale-x, 1.05), var(--fa-bounce-land-scale-y, 0.95)) translateY(0); transform: scale(var(--fa-bounce-land-scale-x, 1.05), var(--fa-bounce-land-scale-y, 0.95)) translateY(0); } 57% { -webkit-transform: scale(1, 1) translateY(var(--fa-bounce-rebound, -0.125em)); transform: scale(1, 1) translateY(var(--fa-bounce-rebound, -0.125em)); } 64% { -webkit-transform: scale(1, 1) translateY(0); transform: scale(1, 1) translateY(0); } 100% { -webkit-transform: scale(1, 1) translateY(0); transform: scale(1, 1) translateY(0); } } @keyframes fa-bounce { 0% { -webkit-transform: scale(1, 1) translateY(0); transform: scale(1, 1) translateY(0); } 10% { -webkit-transform: scale(var(--fa-bounce-start-scale-x, 1.1), var(--fa-bounce-start-scale-y, 0.9)) translateY(0); transform: scale(var(--fa-bounce-start-scale-x, 1.1), var(--fa-bounce-start-scale-y, 0.9)) translateY(0); } 30% { -webkit-transform: scale(var(--fa-bounce-jump-scale-x, 0.9), var(--fa-bounce-jump-scale-y, 1.1)) translateY(var(--fa-bounce-height, -0.5em)); transform: scale(var(--fa-bounce-jump-scale-x, 0.9), var(--fa-bounce-jump-scale-y, 1.1)) translateY(var(--fa-bounce-height, -0.5em)); } 50% { -webkit-transform: scale(var(--fa-bounce-land-scale-x, 1.05), var(--fa-bounce-land-scale-y, 0.95)) translateY(0); transform: scale(var(--fa-bounce-land-scale-x, 1.05), var(--fa-bounce-land-scale-y, 0.95)) translateY(0); } 57% { -webkit-transform: scale(1, 1) translateY(var(--fa-bounce-rebound, -0.125em)); transform: scale(1, 1) translateY(var(--fa-bounce-rebound, -0.125em)); } 64% { -webkit-transform: scale(1, 1) translateY(0); transform: scale(1, 1) translateY(0); } 100% { -webkit-transform: scale(1, 1) translateY(0); transform: scale(1, 1) translateY(0); } } @-webkit-keyframes fa-fade { 50% { opacity: var(--fa-fade-opacity, 0.4); } } @keyframes fa-fade { 50% { opacity: var(--fa-fade-opacity, 0.4); } } @-webkit-keyframes fa-beat-fade { 0%, 100% { opacity: var(--fa-beat-fade-opacity, 0.4); -webkit-transform: scale(1); transform: scale(1); } 50% { opacity: 1; -webkit-transform: scale(var(--fa-beat-fade-scale, 1.125)); transform: scale(var(--fa-beat-fade-scale, 1.125)); } } @keyframes fa-beat-fade { 0%, 100% { opacity: var(--fa-beat-fade-opacity, 0.4); -webkit-transform: scale(1); transform: scale(1); } 50% { opacity: 1; -webkit-transform: scale(var(--fa-beat-fade-scale, 1.125)); transform: scale(var(--fa-beat-fade-scale, 1.125)); } } @-webkit-keyframes fa-flip { 50% { -webkit-transform: rotate3d(var(--fa-flip-x, 0), var(--fa-flip-y, 1), var(--fa-flip-z, 0), var(--fa-flip-angle, -180deg)); transform: rotate3d(var(--fa-flip-x, 0), var(--fa-flip-y, 1), var(--fa-flip-z, 0), var(--fa-flip-angle, -180deg)); } } @keyframes fa-flip { 50% { -webkit-transform: rotate3d(var(--fa-flip-x, 0), var(--fa-flip-y, 1), var(--fa-flip-z, 0), var(--fa-flip-angle, -180deg)); transform: rotate3d(var(--fa-flip-x, 0), var(--fa-flip-y, 1), var(--fa-flip-z, 0), var(--fa-flip-angle, -180deg)); } } @-webkit-keyframes fa-shake { 0% { -webkit-transform: rotate(-15deg); transform: rotate(-15deg); } 4% { -webkit-transform: rotate(15deg); transform: rotate(15deg); } 8%, 24% { -webkit-transform: rotate(-18deg); transform: rotate(-18deg); } 12%, 28% { -webkit-transform: rotate(18deg); transform: rotate(18deg); } 16% { -webkit-transform: rotate(-22deg); transform: rotate(-22deg); } 20% { -webkit-transform: rotate(22deg); transform: rotate(22deg); } 32% { -webkit-transform: rotate(-12deg); transform: rotate(-12deg); } 36% { -webkit-transform: rotate(12deg); transform: rotate(12deg); } 40%, 100% { -webkit-transform: rotate(0deg); transform: rotate(0deg); } } @keyframes fa-shake { 0% { -webkit-transform: rotate(-15deg); transform: rotate(-15deg); } 4% { -webkit-transform: rotate(15deg); transform: rotate(15deg); } 8%, 24% { -webkit-transform: rotate(-18deg); transform: rotate(-18deg); } 12%, 28% { -webkit-transform: rotate(18deg); transform: rotate(18deg); } 16% { -webkit-transform: rotate(-22deg); transform: rotate(-22deg); } 20% { -webkit-transform: rotate(22deg); transform: rotate(22deg); } 32% { -webkit-transform: rotate(-12deg); transform: rotate(-12deg); } 36% { -webkit-transform: rotate(12deg); transform: rotate(12deg); } 40%, 100% { -webkit-transform: rotate(0deg); transform: rotate(0deg); } } @-webkit-keyframes fa-spin { 0% { -webkit-transform: rotate(0deg); transform: rotate(0deg); } 100% { -webkit-transform: rotate(360deg); transform: rotate(360deg); } } @keyframes fa-spin { 0% { -webkit-transform: rotate(0deg); transform: rotate(0deg); } 100% { -webkit-transform: rotate(360deg); transform: rotate(360deg); } } .fa-rotate-90 { -webkit-transform: rotate(90deg); transform: rotate(90deg); } .fa-rotate-180 { -webkit-transform: rotate(180deg); transform: rotate(180deg); } 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href="https://www.benzinga.com/general/biotech/24/11/42190728/lexaria-bioscience-provides-strategic-update-says-semaglutide-being-investigated-for-applications"><span class="sc-jrYeOy keJVHo post-title"><div class="sc-eoyEPH sc-bqnmEL kxsRHy cYNRDk line-wrapper three-line post-card-title leading-normal text-2xl"><span>Lexaria Bioscience Provides Strategic Update; Says Semaglutide Being Investigated For Applications In Heart Disease, Alzheimer's, Liver Disease, And More; GLP-1 Drugs Expected To Generate Multi-Hundreds Of Billions Of Revenues In The Years To Come</span></div></span></a><div class="post-card-article-link flex items-center"><div class="sc-bztcrM celCuA"></div></div></div></div></div></div></div><div class="newsfeed-card text-black"><div class="sc-fJmXnk hDhsmL post-card-wrapper"><div class="sc-cRXXqp fuwIiq post-card post-card-feed post-card-size-nano" title="FDA Approves UCB's Psoriasis Drug For Expanded Use In Painful Inflammatory Skin Disease"><a 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3840w" class="sc-hfNEMC iqYQVB post-thumb" decoding="async" loading="lazy" style="border:none;bottom:0;box-sizing:border-box;display:block;height:0;left:0;margin:auto;max-height:100%;max-width:100%;min-height:100%;min-width:100%;padding:0;position:absolute;right:0;top:0;width:0;object-fit:cover"/></noscript></span></a><div class="post-card-text lg:w-auto flex flex-col space-y-2"><div class="post-card-text-wrapper"><a class="post-card-article-link" href="https://www.benzinga.com/markets/cannabis/24/11/41781038/massachusetts-votes-down-psychedelic-therapy-after-hard-fought-legalization-campaign-whats-next"><span class="sc-jrYeOy keJVHo post-title"><div class="sc-eoyEPH sc-bqnmEL kxsRHy cYNRDk line-wrapper three-line post-card-title leading-normal text-2xl"><span>Massachusetts Votes Down Psychedelic Therapy After Hard-Fought Legalization Campaign, What's Next?</span></div></span></a><div class="post-card-article-link flex items-center"><div class="sc-bztcrM celCuA"></div></div></div></div></div></div></div><div class="feed-more-wrapper"><button class="load-more-button" tabindex="0">Load More <div><svg aria-hidden="true" class="leading-none" stroke="currentColor" stroke-width="1" style="height:1em;width:1em" viewBox="0 0 512 512" xmlns="http://www.w3.org/2000/svg"><path d="M233.4 406.6c12.5 12.5 32.8 12.5 45.3 0l192-192c12.5-12.5 12.5-32.8 0-45.3s-32.8-12.5-45.3 0L256 338.7 86.6 169.4c-12.5-12.5-32.8-12.5-45.3 0s-12.5 32.8 0 45.3l192 192z" fill="currentColor"></path></svg></div></button></div></div></div><div class="sc-kNnbAW bHDHMZ"><div class="sc-jXIZMl dJDsIT money-blocks-wrapper"><div></div><div></div><h2 class="block core-block" id="what-is-an-f-d-a-calendar">What is an FDA Calendar?</h2><p class="block core-block">Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment strategy is to make informed decisions, being in the know of when to expect these events, how these events will pan out and the potential stock reaction in the run-up to the event and post the event.</p><p class="block core-block">Benzinga’s FDA calendar is a meaningfully designed, user friendly, dynamically updated and simplistic investment tool that is a ‘must-have’ for those looking to make money from the volatility that is typic of trading in biotech stocks.</p><p class="block core-block">The calendar lists down all key catalysts that can materially impact stocks, including:</p><ul class="block core-block"><li>PDUFA dates, or in other words FDA decision dates</li><li>Filing schedules for regulatory applications such as new drug application, or NDA, supplemental NDA, Biologic License Application, or BLA, supplemental BLA, Premarket Approval Application, or Premarket Notification 510(k), etc</li><li>FDA decisions (approvals/complete response letter/delay)</li><li>According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc.</li><li>FDA’s Advisory Committee, or Adcom, meetings</li><li>Review meetings with FDA (pre-investigational new drug application meetings, end-of-phase meetings, Type A, Type B and Type C meetings)</li><li>Decisions by overseas regulatory agencies</li><li>Clinical data readouts</li><li>Presentation of data at various scientific conferences.</li></ul><p class="block core-block">The calendar allows data screening, based on company names or tickers, events, date-wise or based on a date range. They are designed to serve as a ‘one-stop shop’ for data needs of investors, both existing and potential, to capitalize on the opportunities these catalysts throw up or cut the losses from an adverse development. </p><h2 class="block core-block" id="what-is-a-catalyst">What is a Catalyst?</h2><p class="block core-block">A catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes. </p><h2 class="block core-block" id="biotech-stock-movers"><strong>Biotech Stock Movers</strong></h2><p class="block core-block">Regulatory actions and clinical readouts are stock-moving catalysts. The magnitude of the impact is usually disproportionate. Most clinical-stage biotechs, or companies which are yet to commercialize a product, do not generate revenues. The exceptions are those which may have out-licensed therapies-in-development to another company and as a result generate revenues in the form of licensing revenues. So, it will be years of investment (time money and efforts) into drug development, which usually takes about 10-15 years, on the promise of generating future returns.</p><p class="block core-block">A promising outcome in a particular stage of drug development is perceived by the market as an incremental step in bringing the company closer to that distant goal of marketing a potential blockbuster drug that could fetch it billions in revenues. This explains the huge positive move in a stock when a company reports a positive clinical readout.</p><p class="block core-block">Similarly, an unfavorable or a partially successful outcome could suggest all the investment the company may have made in the investigational therapy could go down the drain. Quite appropriately, investors punish the stock by selling it in droves.</p><p class="block core-block">PDUFA and Adcom events are binary events that have two outcomes, triggering moves in stock depending on which outcome materializes.</p><div class="my-6"><div class="sc-bsJwXR fRtGzP stock-movers-container default"><div class="header-container"><div class="sc-kKMBOm dYVJHD styled-line"></div><h2>Stock Movers</h2><div class="sc-kKMBOm dYVJHD styled-line"></div></div><div class="stock-movers-table-container full-width-table flex" id="full-width-movers-table"><div><header class="sc-fUzjWc eykRRj tab"><div style="margin-right:2px"><svg aria-hidden="true" class="leading-none" stroke="currentColor" stroke-width="1" style="height:1em;width:1em" viewBox="0 0 320 512" xmlns="http://www.w3.org/2000/svg"><path d="M182.6 137.4c-12.5-12.5-32.8-12.5-45.3 0l-128 128c-9.2 9.2-11.9 22.9-6.9 34.9s16.6 19.8 29.6 19.8H288c12.9 0 24.6-7.8 29.6-19.8s2.2-25.7-6.9-34.9l-128-128z" fill="currentColor"></path></svg></div><h3>Gainers</h3></header><div class="sc-gKQHmE gnpDuc stock-movers-table"><div class="stock-movers-table-wrapper overflow-x-auto"><table><thead class="whitespace-nowrap"><tr><th class="ticker" colSpan="1">Ticker</th><th colSpan="2">Company</th><th class="close" colSpan="1"><button class="w-full">Close<div class="header-sort-icons"><span class="header-sort-icon header-sort-icon__up ">▲</span><span class="header-sort-icon header-sort-icon__down ">▼</span></div></button></th><th class="change-percent">±%</th><th class="average-volume" colSpan="1"><button>Avg. Vol<div class="header-sort-icons"><span class="header-sort-icon header-sort-icon__up ">▲</span><span class="header-sort-icon header-sort-icon__down ">▼</span></div></button></th><th class="buy-stock-table-header w-[60px] text-right" colSpan="1">Buy Stock</th></tr></thead><tbody class="no-results"><tr><td><div class="h-full w-full text-center p-4">Loading...</div></td></tr></tbody></table></div><a class="benzinga-pro-link" data-label="Get Real Time Movers" href="https://www.benzinga.com/go/benzinga-pro/">Get in real-time</a></div></div><div><header class="sc-fUzjWc edbiuk tab"><div style="margin-right:2px"><svg aria-hidden="true" class="leading-none" stroke="currentColor" stroke-width="1" style="height:1em;width:1em" viewBox="0 0 320 512" xmlns="http://www.w3.org/2000/svg"><path d="M137.4 374.6c12.5 12.5 32.8 12.5 45.3 0l128-128c9.2-9.2 11.9-22.9 6.9-34.9s-16.6-19.8-29.6-19.8L32 192c-12.9 0-24.6 7.8-29.6 19.8s-2.2 25.7 6.9 34.9l128 128z" fill="currentColor"></path></svg></div><h3>Loser</h3></header><div class="sc-gKQHmE gnpDuc stock-movers-table"><div class="stock-movers-table-wrapper overflow-x-auto"><table><thead class="whitespace-nowrap"><tr><th class="ticker" colSpan="1">Ticker</th><th colSpan="2">Company</th><th class="close" colSpan="1"><button class="w-full">Close<div class="header-sort-icons"><span class="header-sort-icon header-sort-icon__up ">▲</span><span class="header-sort-icon header-sort-icon__down ">▼</span></div></button></th><th class="change-percent">±%</th><th class="average-volume" colSpan="1"><button>Avg. Vol<div class="header-sort-icons"><span class="header-sort-icon header-sort-icon__up ">▲</span><span class="header-sort-icon header-sort-icon__down ">▼</span></div></button></th><th class="buy-stock-table-header w-[60px] text-right" colSpan="1">Buy Stock</th></tr></thead><tbody class="no-results"><tr><td><div class="h-full w-full text-center p-4">Loading...</div></td></tr></tbody></table></div><a class="benzinga-pro-link" data-label="Get Real Time Movers" href="https://www.benzinga.com/go/benzinga-pro/">Get in real-time</a></div></div></div></div></div><div class="lazyload-wrapper "><div class="min-h-[300px] md:min-h-[186px] my-4"><div class="w-full min-h-[inherit]"><div class="w-full h-full min-h-[inherit] flex items-center justify-center mx-auto rounded-md border border-gray-300 p-4 shadow"><div class="flex flex-col md:flex-row animate-pulse w-full gap-4"><div class="icon-wrapper flex items-center justify-center mx-6"><svg aria-hidden="true" class="w-16 h-16 text-gray-400" fill="currentColor" viewBox="0 0 640 512" xmlns="http://www.w3.org/2000/svg"><path d="M480 80C480 35.82 515.8 0 560 0C604.2 0 640 35.82 640 80C640 124.2 604.2 160 560 160C515.8 160 480 124.2 480 80zM0 456.1C0 445.6 2.964 435.3 8.551 426.4L225.3 81.01C231.9 70.42 243.5 64 256 64C268.5 64 280.1 70.42 286.8 81.01L412.7 281.7L460.9 202.7C464.1 196.1 472.2 192 480 192C487.8 192 495 196.1 499.1 202.7L631.1 419.1C636.9 428.6 640 439.7 640 450.9C640 484.6 612.6 512 578.9 512H55.91C25.03 512 .0006 486.1 .0006 456.1L0 456.1z"></path></svg></div><div class="paragraphs-wrapper w-full"><div class="flex-1 space-y-6 py-1"><div class="h-3 rounded bg-gray-300"></div><div class="space-y-3"><div class="grid grid-cols-3 gap-4"><div class="col-span-2 h-2 rounded bg-gray-300"></div><div class="col-span-1 h-2 rounded bg-gray-300"></div></div><div class="h-2 rounded bg-gray-300"></div><div class="h-2 rounded bg-gray-300"></div><div class="h-2 rounded bg-gray-300"></div></div></div></div></div></div></div></div></div><h2 class="block core-block" id="frequently-asked-questions">Frequently Asked Questions</h2><div class="sc-bkTvXO byiCky block"><div class="sc-iZynkD fTLeud faq-container"><div class="sc-dmDyCM issezv faq-block"><div class="sc-dcjOau ioxFuJ qa-container"><div class="qa-header"><div class="qa-letter-icon">Q</div><h3 class="font-bold question">What is an FDA PDUFA date?</h3></div><div class="qa-body"><div class="qa-letter-icon">A</div><div class="answer-container"><p><span style="font-weight: 400;">Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company. The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company.</span></p> <p><span style="font-weight: 400;">PDUFA was passed in the U.S. in 1992, which allows the FDA to collect fees from the sponsor company to fund the review process.</span></p> <p><span style="font-weight: 400;">A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional clinical studies to establish the efficacy and/or safety of the treatment option, problems with chemistry, manufacturing and controls, etc.</span></p> <p><span style="font-weight: 400;">A delay in the review period may stem from the FDA needs additional time to review any additional data/information that may have been tabled subsequent to the submission of the regulatory application or the FDA’s inability to complete site inspections where the drug ingredients are being made etc.</span></p> <p><span style="font-weight: 400;">The FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based on the data of filing the regulatory application. If the company doesn’t provide a timeline either, it is left to the investors to do the calculations.</span></p> </div></div></div><div class="sc-dcjOau ioxFuJ qa-container"><div class="qa-header"><div class="qa-letter-icon">Q</div><h3 class="font-bold question">How long does an FDA approval take? </h3></div><div class="qa-body"><div class="qa-letter-icon">A</div><div class="answer-container"><p><span style="font-weight: 400;">A regulatory application (NDA, sNDA, BLA, sBLA, etc.) is usually accepted for standard review or priority review. A standard review will mean the FDA has to hand out its verdict within 10 months of filing the application. The review window for a priority review gets shortened to six months.</span></p> <p><span style="font-weight: 400;">Once a company files for a regulatory application, the FDA takes up to 60 days to respond with an ‘accepted for review’ or ‘refuse-to-file’ decision.</span></p> </div></div></div><div class="sc-dcjOau ioxFuJ qa-container"><div class="qa-header"><div class="qa-letter-icon">Q</div><h3 class="font-bold question">How do you find FDA approvals?</h3></div><div class="qa-body"><div class="qa-letter-icon">A</div><div class="answer-container"><p><span style="font-weight: 400;">A Catalysts Calendar is one way of tracking all the </span><span style="font-weight: 400;">decisions in a single place. Usually, the FDA puts out a release and/or communicates to the company, which in turn will issue a press release.</span></p> </div></div></div></div></div></div></div></div></div></div><div><div class="sc-hEwMvu hNGBRL layout-sidebar flex-none justify-between"><div class="lazyload-wrapper "><div class="lazyload-placeholder"></div></div></div></div></div></div></div></div></div><div class="footer"><div class="footer-top-section"><div class="benzinga-links-section"><div class="logo-and-socials-wrapper"><span class="sc-cAYQHL cLmRhK benzinga-logo light presentation"><svg height="100%" role="img" viewBox="0 0 471.1 63.8" width="100%" xmlns="http://www.w3.org/2000/svg"><path d="M67.7 63.8h45.2V51.9H81.4V37.3h26.1V25.4H81.4V11.9h31.7V0H67.7zm99.6-23.6L137.7 0h-20.4l6.4 8.1V64h13.6V22.1l30.6 41.7H181V0h-13.7zM47.1 31c6-1.1 11-6.7 11-14.6C58.1 7.9 51.9 0 39.6 0H0l6.2 7.9v56H41c12.3 0 18.7-7.7 18.7-17.3-.3-7.9-5.7-14.7-12.6-15.6zM19.8 12h17.1c4.6 0 7.5 2.7 7.5 6.7s-2.9 6.7-7.5 6.7H19.8V12zm17.7 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type="application/json">{"props":{"pageProps":{"calendarDataSet":[{"commentary":"","companies":[{"cik":"1070081","id":"603cef7db9e30d000188f28a","name":"PTC Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"PTCT"}]}],"created":1732658933,"date":"2024-11-26","drug":{"generic":false,"id":"67445d9372fb4d00010df323","indication_symptom":["In ALS Patients"],"name":"Utreloxastat"},"event_type":"Endpoint Missed","id":"674646f5eee39a0001359513","nic_number":"","notes":"","outcome":"PTC Therapeutics, Inc. announced that the global Phase 2 placebo-controlled CardinALS study did not meet its primary endpoint of slowing disease progression on the composite ALSFRS-R and mortality analysis.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42201952/ptc-therapeutics-announces-topline-results-of-cardinals-trial-of-utreloxastat-in-als-patients","source_type":"Press Release","status":"Phase 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2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42200745/exelixis-provides-regulatory-update-related-to-supplemental-new-drug-application-for-cabozantinib-","source_type":"Press Release","status":"","target_date":"","time":"16:40:37","updated":1732657426},{"commentary":"","companies":[{"cik":"1314052","id":"603cef7ab9e30d000188ceff","name":"Anavex Life Sciences Corp","securities":[{"exchange":"NASDAQ","symbol":"AVXL"}]}],"created":1732627269,"date":"2024-11-26","drug":{"generic":false,"id":"60bfdc75f0c52b0001fcb498","indication_symptom":["Alzheimer's Disease"],"name":"ANAVEX 2-73 (blarcamesine)"},"event_type":"Application Submitted","id":"6745cb45f5ad710001484455","nic_number":"","notes":"","outcome":"Anavex Life Sciences Corp. announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission is for the treatment of Alzheimer's Disease.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42186185/anavex-life-sciences-announces-submission-of-blarcamesine-maa-for-treatment-of-alzheimers-disease-","source_type":"Press Release","status":"","target_date":"","time":"08:21:09","updated":1732627329},{"commentary":"","companies":[{"cik":"","id":"622a47f8cc9cd90001f8ede8","name":"Cognition Therapeutics, Inc.","securities":[{"exchange":"NASDAQ","symbol":"CGTX"}]}],"created":1732627182,"date":"2024-11-26","drug":{"generic":false,"id":"64a55e8f1d538a0001e7473b","indication_symptom":["Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex. 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"],"name":"CT1812"},"event_type":"Provided Update","id":"6745cacdf5ad710001484428","nic_number":"","notes":"","outcome":"Cognition Therapeutics, announced that the last patient has completed their final clinic visit in the Phase 2 SHIMMER study of CT1812 in patients with mild-to-moderate dementia with Lewy bodies (DLB).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42186242/cognition-therapeutics-announces-all-participants-have-completed-their-final-visits-in-the-phase-2","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:19:09","updated":1732627236},{"commentary":"","companies":[{"cik":"1610820","id":"603cef7bb9e30d000188dc95","name":"BriaCell Therapeutics Corp","securities":[{"exchange":"TSX","symbol":"BCT"},{"exchange":"NASDAQ","symbol":"BCTX"}]}],"created":1732626883,"date":"2024-11-26","drug":{"generic":false,"id":"6256d775d52f390001cfc43d","indication_symptom":["Metastatic breast cancer (breast cancer that has spread beyond the breast)"],"name":"Bria-IMT"},"event_type":"Survival data","id":"6745c9c3f5ad7100014843ed","nic_number":"","notes":"","outcome":"BriaCell Therapeutics Corp will be highlighting its positive overall survival and clinical benefit data in metastatic breast cancer (MBC) patients including those with CNS metastasis (not shown on the abstracts) who were treated with the Bria-IMT™ plus immune checkpoint inhibitor (CPI) combination in its \"Spotlight\" poster presentation session, at the 2024 San Antonio Breast Cancer Symposium® (SABCS®) held at Henry B. Gonzalez Convention Center, San Antonio, TX.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42186604/briacell-2024-sabcs-spotlight-poster-to-showcase-positive-overall-survival-data-across-all-patient","source_type":"Press Release","status":"","target_date":"","time":"08:14:43","updated":1732627046},{"commentary":"","companies":[{"cik":"1668243","id":"603cef7eb9e30d000188fa66","name":"UroGen Pharma Ltd","securities":[{"exchange":"NASDAQ","symbol":"URGN"}]}],"created":1732626691,"date":"2024-11-26","drug":{"generic":false,"id":"6489b22c38ab3c0001934f62","indication_symptom":[" For primary chemoablative treatment of LG-UTUC in adults."],"name":"JELMYTO® (mitomycin)"},"event_type":"Highlights","id":"6745c903f5ad7100014843bb","nic_number":"","notes":"","outcome":"UroGen Pharma Ltd today highlights results from a long-term follow-up study with JELMYTO (mitomycin) for pyelocalyceal solution, which is FDA approved for the treatment of low-grade, upper tract urothelial cancer (LG-UTUC) in adult patients.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42187881/new-data-from-a-long-term-follow-up-study-to-the-olympus-trial-show-median-duration-of-response-of","source_type":"Press Release","status":"","target_date":"","time":"08:11:31","updated":1732626763},{"commentary":"","companies":[{"cik":"","id":"61ba5a74d64b280001d578c7","name":"Ensysce Biosciences, Inc.","securities":[{"exchange":"NASDAQ","symbol":"ENSC"}]}],"created":1732626542,"date":"2024-11-26","drug":{"generic":false,"id":"61ba5a43d64b280001d578c1","indication_symptom":["Opioid overdose"],"name":"PF614-MPAR"},"event_type":"Provided Update","id":"6745c86ef5ad710001484386","nic_number":"","notes":"","outcome":"Ensysce Biosciences, Inc. announced that it has treated its first group of subjects in the PF614-MPAR-102 study.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42187975/ensysce-biosciences-completes-significant-milestone-dosing-first-subjects-in-breakthrough-therapy","source_type":"Press Release","status":"","target_date":"","time":"08:09:02","updated":1732626638},{"commentary":"","companies":[{"cik":"","id":"61ba5a74d64b280001d578c7","name":"Ensysce Biosciences, Inc.","securities":[{"exchange":"NASDAQ","symbol":"ENSC"}]}],"created":1732626574,"date":"2024-11-26","drug":{"generic":false,"id":"61ba5a43d64b280001d578c1","indication_symptom":["Opioid overdose"],"name":"PF614-MPAR"},"event_type":"Interim Data","id":"6745c88ef5ad71000148439b","nic_number":"","notes":"","outcome":"Ensysce Biosciences Expects Early Interim Data in 1Q 2025","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42187975/ensysce-biosciences-completes-significant-milestone-dosing-first-subjects-in-breakthrough-therapy","source_type":"Press 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Release","status":"","target_date":"2025-Q1","time":"08:07:46","updated":1732626526},{"commentary":"","companies":[{"cik":"1062822","id":"603cef78b9e30d000188b91c","name":"Lexicon Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"LXRX"}]}],"created":1732626285,"date":"2024-11-26","drug":{"generic":false,"id":"67445d9372fb4d00010df325","indication_symptom":["In Diabetic Peripheral Neuropathic Pain (DPNP)"],"name":"LX9211"},"event_type":"Enrollment Update","id":"6745c76df5ad710001484319","nic_number":"","notes":"","outcome":"Lexicon Pharmaceuticals, Inc announced the completion of patient enrollment in the PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating LX9211, a novel, orally-delivered, selective investigational small molecule inhibitor of adaptor-associated kinase 1 (AAK1), for the treatment of diabetic peripheral neuropathic pain (DPNP).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42187872/lexicon-announces-completion-of-enrollment-in-phase-2b-progress-study-of-lx9211-in-diabetic-periph","source_type":"Press Release","status":"","target_date":"","time":"08:04:45","updated":1732626525},{"commentary":"","companies":[{"cik":"","id":"664c5fb757d42200014c051a","name":"Amgen","securities":[]}],"created":1732624050,"date":"2024-11-26","drug":{"generic":false,"id":"672b343a86a8560001f8f2f9","indication_symptom":["For weight loss"],"name":"MariTide (AMG 133)"},"event_type":"Positive Data","id":"6745beb22d72ce0001cb69f9","nic_number":"","notes":"","outcome":"Amgen announced positive data at 52 weeks in a double-blind, dose-ranging Phase 2 study with MariTide (maridebart cafraglutide, formerly AMG 133), an investigational antibody peptide conjugate subcutaneously administered monthly or less frequently","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42185604/amgen-announces-robust-weight-loss-with-maritide-in-people-living-with-obesity-or-overweight-at-52","source_type":"Press Release","status":"Phase 2","target_date":"","time":"07:27:30","updated":1732624125},{"commentary":"","companies":[{"cik":"1579428","id":"603cef7eb9e30d000188f7e1","name":"Axsome Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"AXSM"}]}],"created":1732623923,"date":"2024-11-26","drug":{"generic":false,"id":"6143969046584a0001453ac2","indication_symptom":["Narcolepsy"],"name":"AXS-12"},"event_type":"Endpoint Met","id":"6745be332d72ce0001cb69c6","nic_number":"","notes":"","outcome":"Axsome Therapeutics, Inc. announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint in the ENCORE Phase 3 trial, demonstrating a statistically significant improvement in the frequency of cataplexy attacks compared to placebo.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42185380/axsome-therapeutics-announces-axs-12-achieves-primary-endpoint-in-encore-long-term-phase-3-trial-i","source_type":"Press Release","status":"Phase 3","target_date":"","time":"07:25:23","updated":1732623999},{"commentary":"","companies":[{"cik":"896566","id":"603cef78b9e30d000188bac2","name":"Roche Holding AG","securities":[{"exchange":"OTC","symbol":"RHHBF"},{"exchange":"OTC","symbol":"RHHBY"},{"exchange":"OTC","symbol":"RHHVF"}]}],"created":1732606484,"date":"2024-11-26","drug":{"generic":false,"id":"64c0cdc09c212e000152226a","indication_symptom":["Treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC)."],"name":"tiragolumab"},"event_type":"Provided Update","id":"67457a142d72ce0001cb5f5c","nic_number":"","notes":"","outcome":"Roche Group reports an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq® (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42180834/genentech-reports-update-on-phase-iii-skyscraper-01-study-results","source_type":"Press Release","status":"","target_date":"","time":"02:34:44","updated":1732606542},{"commentary":"","companies":[{"cik":"1604821","id":"603cef7eb9e30d000188f716","name":"Natera Inc","securities":[{"exchange":"NASDAQ","symbol":"NTRA"}]}],"created":1732592677,"date":"2024-11-25","drug":{"generic":false,"id":"605b87b68b50090001281f02","indication_symptom":["MRD Test for cancer therapies"],"name":"Signatera"},"event_type":"Presentation","id":"6745442572fb4d00010e314d","nic_number":"","notes":"","outcome":"Natera, Inc. announced that it will present new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), taking place Dec. 10-13 in San Antonio, TX. Natera and its collaborators will present a total of six abstracts.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42179286/natera-to-present-new-signateratm-data-in-multiple-abstracts-at-the-san-antonio-breast-cancer-symp","source_type":"Press Release","status":"","target_date":"","time":"22:44:37","updated":1732592730},{"commentary":"","companies":[{"cik":"1750284","id":"603cef7fb9e30d0001890329","name":"Olema Pharmaceuticals inc","securities":[{"exchange":"NASDAQ","symbol":"OLMA"}]}],"created":1732592053,"date":"2024-11-25","drug":{"generic":false,"id":"609af52323c8c70001b95c8e","indication_symptom":["Metastatic"," ER+ / HER2- breast cancer"],"name":"OP-1250"},"event_type":"Data Presentation","id":"674541b52d72ce0001cb5c73","nic_number":"","notes":"","outcome":"Olema Pharmaceuticals, announced that it will present new data from the Phase 1b/2 clinical study of palazestrant (OP-1250) in combination with CDK4/6 inhibitor ribociclib at the San Antonio Breast Cancer Symposium (SABCS 2024) being held December 10-13, 2024, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42177528/olema-oncology-to-present-new-data-combining-palazestrant-with-ribociclib-at-the-san-antonio-breas","source_type":"Press Release","status":"Phase 1b/2","target_date":"","time":"22:34:13","updated":1732592636},{"commentary":"","companies":[{"cik":"1653087","id":"603cef7eb9e30d000188fe5c","name":"Alector Inc","securities":[{"exchange":"NASDAQ","symbol":"ALEC"}]}],"created":1732591953,"date":"2024-11-25","drug":{"generic":false,"id":"60f895a048f06700014e3322","indication_symptom":["Early Alzheimer's Disease"],"name":"AL002 (INVOKE-2)"},"event_type":"Results","id":"674541512d72ce0001cb5c5f","nic_number":"","notes":"","outcome":"Alector, Inc. announced results from the INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer's disease (AD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42174676/alector-announces-results-from-al002-invoke-2-phase-2-trial-in-individuals-with-early-alzheimers-d","source_type":"Press Release","status":"Phase 2","target_date":"","time":"22:32:33","updated":1732592020},{"commentary":"","companies":[{"cik":"1177648","id":"603cef7db9e30d000188f192","name":"Enanta Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ENTA"}]}],"created":1732591804,"date":"2024-11-25","drug":{"generic":false,"id":"642ea8c77dfba500019d2b2c","indication_symptom":["Eduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B"],"name":"EDP-323"},"event_type":"Provided Update","id":"674540bc2d72ce0001cb5c49","nic_number":"","notes":"","outcome":"Enanta Pharmaceuticals, Inc provides clinical updates","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42174560/enanta-pharmaceuticals-reports-financial-results-for-its-fiscal-fourth-quarter-and-year-ended-sept","source_type":"Press Release","status":"","target_date":"","time":"22:30:04","updated":1732591860},{"commentary":"","companies":[{"cik":"1340243","id":"603cef7ab9e30d000188d4f4","name":"MorphoSys AG","securities":[{"exchange":"NASDAQ","symbol":"MOR"},{"exchange":"OTC","symbol":"MPSYF"}]},{"cik":"879169","id":"603cef79b9e30d000188bfd2","name":"Incyte Corp","securities":[{"exchange":"NASDAQ","symbol":"INCY"}]}],"created":1732591219,"date":"2024-11-25","drug":{"generic":false,"id":"607df86ec3b1140001387667","indication_symptom":["Relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL)"],"name":"Tafasitamab + (Lenalidomide and Rituximab)"},"event_type":"New Data","id":"67453e73f5ad71000148349e","nic_number":"","notes":"","outcome":"Incyte announced that the Company will present new data from across its oncology portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42166250/incyte-to-spotlight-new-data-including-a-late-breaking-oral-presentation-for-tafasitamab-in-follic","source_type":"Press Release","status":"","target_date":"","time":"22:20:19","updated":1732591300},{"commentary":"","companies":[{"cik":"","id":"6317c0a4ec9f4200017b1da3","name":"Tenaya Therapeutics, Inc.","securities":[{"exchange":"NASDAQ","symbol":"TNYA"}]}],"created":1732540319,"date":"2024-11-25","drug":{"generic":false,"id":"65f821b3cad84c000180aa89","indication_symptom":["For the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC) caused by Plakophilin-2 (PKP2) gene mutations. "],"name":"TN-401"},"event_type":"Dose Update","id":"6744779f2d72ce0001cb1d8f","nic_number":"","notes":"","outcome":"Tenaya Therapeutics, Inc. announced that the first patient has been dosed with TN-401 gene therapy in the RIDGE-1 Phase 1b clinical trial at the University of California, San Francisco.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42162729/tenaya-therapeutics-doses-first-patient-in-ridge-1-phase-1b-clinical-trial-of-tn-401-for-the-treat","source_type":"Press Release","status":"Phase 1b","target_date":"","time":"08:11:59","updated":1732542817},{"commentary":"","companies":[{"cik":"","id":"659ce7728fadc30001181056","name":"IGC Pharma Inc","securities":[]}],"created":1732540320,"date":"2024-11-25","drug":{"generic":false,"id":"6655d2d43b127300013915be","indication_symptom":["For Agitation in Alzheimer's disease."],"name":"IGC-AD1"},"event_type":"Additional data","id":"674477a02d72ce0001cb1d91","nic_number":"","notes":"","outcome":"IGC Pharma, Inc. announced additional interim data from its ongoing Phase 2 clinical trial evaluating IGC-AD1.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42162746/igc-pharma-announces-additional-phase-2-interim-results-highlighting-cognitive-benefits-of-igc-ad1","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:12:00","updated":1732542739},{"commentary":"","companies":[{"cik":"","id":"60b62232c878010001d61df3","name":"NRx Pharmaceuticals","securities":[{"exchange":"NASDAQ","symbol":"NRXP"}]}],"created":1732540320,"date":"2024-11-25","drug":{"generic":false,"id":"627d29da766cb1000166f277","indication_symptom":["Bipolar Depression with Sub-Acute Suicidality"],"name":"NRX-101"},"event_type":"Publication","id":"674477a02d72ce0001cb1d93","nic_number":"","notes":"","outcome":"NRx Pharmaceuticals, Inc. announced the publication of a paper by Sapko, et. al. in the peer-reviewed American Journal of Clinical Psychopharmacology.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42161924/nrx-pharmaceuticals-nasdaq-nrxp-announces-publication-of-paper-entitled-quality-assurance-of-depre","source_type":"Press Release","status":"","target_date":"","time":"08:12:00","updated":1732541205},{"commentary":"","companies":[{"cik":"1506251","id":"603cef7db9e30d000188ef48","name":"Citius Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"CTXR"}]}],"created":1732540320,"date":"2024-11-25","drug":{"generic":false,"id":"605a51e78b500900011de64b","indication_symptom":["Catheter-related bloodstream infections (CRBSIs)"],"name":"Mino-Lok"},"event_type":"FDA Meeting","id":"674477a02d72ce0001cb1d95","nic_number":"","notes":"","outcome":"Citius Pharmaceuticals, Inc. announced that the Company held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42161923/citius-pharmaceuticals-reports-productive-fda-type-c-meeting-to-discuss-phase-3-mino-lok-program-a","source_type":"Press Release","status":"Type C Meeting","target_date":"","time":"08:12:00","updated":1732541150},{"commentary":"","companies":[{"cik":"","id":"65310876c697190001dd8b9c","name":"IMUNON Inc","securities":[]}],"created":1732540319,"date":"2024-11-25","drug":{"generic":false,"id":"64c0cdbc9c212e0001522246","indication_symptom":["For ovarian cancer"],"name":"IMNN-001"},"event_type":"Provided Update","id":"6744779f2d72ce0001cb1d87","nic_number":"","notes":"","outcome":"IMUNON remains on track to initiate the 500-patient Phase 3 trial in the first quarter of 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42161965/imunon-announces-results-from-its-end-of-phase-2-meeting-with-the-fda-for-its-lead-imnn-001-clinic","source_type":"Press Release","status":"Phase 3","target_date":"2025-Q1","time":"08:11:59","updated":1732540399},{"commentary":"","companies":[{"cik":"","id":"65310876c697190001dd8b9c","name":"IMUNON Inc","securities":[]}],"created":1732540215,"date":"2024-11-25","drug":{"generic":false,"id":"64c0cdbc9c212e0001522246","indication_symptom":["For ovarian cancer"],"name":"IMNN-001"},"event_type":"FDA Meeting","id":"67447737f5ad71000147f8d0","nic_number":"","notes":"","outcome":"IMUNON, Inc. announced the outcome of its recent End-of-Phase 2 in-person meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of its investigational interleukin-12 (IL-12) immunotherapy IMNN-001 for the treatment of advanced ovarian cancer into a Phase 3 pivotal study.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42161965/imunon-announces-results-from-its-end-of-phase-2-meeting-with-the-fda-for-its-lead-imnn-001-clinic","source_type":"Press Release","status":"","target_date":"","time":"08:10:15","updated":1732540399},{"commentary":"","companies":[{"cik":"1069530","id":"603cef79b9e30d000188c148","name":"Cassava Sciences Inc","securities":[{"exchange":"NASDAQ","symbol":"SAVA"}]}],"created":1732540101,"date":"2024-11-25","drug":{"generic":false,"id":"6048c8d43c2ff900010c8f94","indication_symptom":["Alzheimer's Disease"],"name":"Simufilam"},"event_type":"Top-line results","id":"674476c5f5ad71000147f89e","nic_number":"","notes":"","outcome":"Cassava Sciences, Inc. announced that the topline results from the Phase 3 ReThink-ALZ study of simufilam in mild-to-moderate AD did not meet each of the pre-specified co-primary, secondary and exploratory biomarker endpoints.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42160859/cassava-sciences-topline-phase-3-data-did-not-meet-co-primary-endpoints","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:08:21","updated":1732540167},{"commentary":"","companies":[{"cik":"1652130","id":"603cef7eb9e30d000188f8ae","name":"Intellia Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"NTLA"}]},{"cik":"872589","id":"603cef78b9e30d000188ba95","name":"Regeneron Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"REGN"}]}],"created":1732540008,"date":"2024-11-25","drug":{"generic":false,"id":"60d8eeef74f1490001e18e91","indication_symptom":["Transthyretin (ATTR) Amyloidosis"],"name":"NTLA-2001"},"event_type":"Designation Grant","id":"67447668f5ad71000147f885","nic_number":"","notes":"","outcome":"Intellia Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to nexiguran ziclumeran (nex-z, also known as NTLA-2001) for the treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42160852/intellia-therapeutics-announces-fda-regenerative-medicine-advanced-therapy-rmat-designation-grante","source_type":"Press Release","status":"Regenerative Medicine Advanced Therapy (RMAT) Designation","target_date":"","time":"08:06:48","updated":1732540083},{"commentary":"","companies":[{"cik":"1314052","id":"603cef7ab9e30d000188ceff","name":"Anavex Life Sciences Corp","securities":[{"exchange":"NASDAQ","symbol":"AVXL"}]}],"created":1732539835,"date":"2024-11-25","drug":{"generic":false,"id":"60bfdc75f0c52b0001fcb498","indication_symptom":["Alzheimer's Disease"],"name":"ANAVEX 2-73 (blarcamesine)"},"event_type":"Publication","id":"674475bbf5ad71000147f826","nic_number":"","notes":"","outcome":"Anavex Life Sciences Corp. announced that Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,\" in a medical journal with focus on Alzheimer's disease. The publication date is expected around Q4 2024","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42160855/anavex-life-sciences-announces-acceptance-of-peer-reviewed-manuscript-of-oral-blarcamesine-phase-i","source_type":"Press Release","status":"","target_date":"2024-Q4","time":"08:03:55","updated":1732539995},{"commentary":"","companies":[{"cik":"1314052","id":"603cef7ab9e30d000188ceff","name":"Anavex Life Sciences Corp","securities":[{"exchange":"NASDAQ","symbol":"AVXL"}]}],"created":1732539735,"date":"2024-11-25","drug":{"generic":false,"id":"60bfdc75f0c52b0001fcb498","indication_symptom":["Alzheimer's Disease"],"name":"ANAVEX 2-73 (blarcamesine)"},"event_type":"Provided Update","id":"67447557f5ad71000147f813","nic_number":"","notes":"","outcome":"Anavex Life Sciences Corp. announced the acceptance of a peer-reviewed manuscript titled, \"Blarcamesine for the treatment of Early Alzheimer's Disease","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42160855/anavex-life-sciences-announces-acceptance-of-peer-reviewed-manuscript-of-oral-blarcamesine-phase-i","source_type":"Press Release","status":"","target_date":"","time":"08:02:15","updated":1732539995},{"commentary":"","companies":[{"cik":"1314052","id":"603cef7ab9e30d000188ceff","name":"Anavex Life Sciences Corp","securities":[{"exchange":"NASDAQ","symbol":"AVXL"}]}],"created":1732539874,"date":"2024-11-25","drug":{"generic":false,"id":"60bfdc75f0c52b0001fcb498","indication_symptom":["Alzheimer's Disease"],"name":"ANAVEX 2-73 (blarcamesine)"},"event_type":"Publication","id":"674475e2f5ad71000147f83e","nic_number":"","notes":"","outcome":"Anavex Life Sciences Corp. announced that Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,\" in a medical journal with focus on Alzheimer's disease. The publication date is expected around Q1 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42160855/anavex-life-sciences-announces-acceptance-of-peer-reviewed-manuscript-of-oral-blarcamesine-phase-i","source_type":"Press Release","status":"","target_date":"2025-Q1","time":"08:04:34","updated":1732539994},{"commentary":"","companies":[{"cik":"911216","id":"603cef79b9e30d000188c149","name":"Palatin Technologies Inc","securities":[{"exchange":"AMEX","symbol":"PTN"}]}],"created":1732539044,"date":"2024-11-25","drug":{"generic":false,"id":"63bd6a0f5750940001b3a452","indication_symptom":["Synthetic cyclic heptapeptide with demonstrated efficacy in multiple animal inflammatory bowel disease models"],"name":"PL8177"},"event_type":"Enrollment Update","id":"674472a4f5ad71000147f766","nic_number":"","notes":"","outcome":"Palatin Technologies, Inc. announced the completion of enrollment in its Phase 2 Study of PL8177, a potent melanocortin-1 receptor (MC1R) agonist, in ulcerative colitis (UC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42160872/palatin-announces-completion-of-patient-enrollment-in-phase-2-study-of-orally-administered-melanoc","source_type":"Press Release","status":"Phase 2","target_date":"","time":"07:50:44","updated":1732539202},{"commentary":"","companies":[{"cik":"911216","id":"603cef79b9e30d000188c149","name":"Palatin Technologies Inc","securities":[{"exchange":"AMEX","symbol":"PTN"}]}],"created":1732539100,"date":"2024-11-25","drug":{"generic":false,"id":"63bd6a0f5750940001b3a452","indication_symptom":["Synthetic cyclic heptapeptide with demonstrated efficacy in multiple animal inflammatory bowel disease models"],"name":"PL8177"},"event_type":"Data","id":"674472dcf5ad71000147f776","nic_number":"","notes":"","outcome":"Palatin Technologies announced that Data expected 1Q calendar year 2025","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42160872/palatin-announces-completion-of-patient-enrollment-in-phase-2-study-of-orally-administered-melanoc","source_type":"Press Release","status":"","target_date":"2025-Q1","time":"07:51:40","updated":1732539201},{"commentary":"","companies":[{"cik":"1095981","id":"603cef78b9e30d000188be73","name":"Plus Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"PSTV"}]}],"created":1732538976,"date":"2024-11-25","drug":{"generic":false,"id":"655b57f72803140001dfc554","indication_symptom":[" For the treatment of recurrent glioblastoma (rGBM)"],"name":"Rhenium (186Re)"},"event_type":"Data Presentation","id":"67447260f5ad71000147f745","nic_number":"","notes":"","outcome":"Plus Therapeutics, Inc. presented data updating the progress of its ReSPECT-LM Phase 1 clinical trial of Rhenium (186Re) Obisbemeda (Rhenium Nanoliposome, 186RNL) in leptomeningeal disease (LM).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42160854/plus-therapeutics-presents-positive-respect-lm-phase-1-interim-data-for-leptomeningeal-metastases-","source_type":"Press Release","status":"Phase 1","target_date":"","time":"07:49:36","updated":1732539035},{"commentary":"","companies":[{"cik":"","id":"6113ec99b6abe40001edcd68","name":"IN8bio Inc.","securities":[{"exchange":"NASDAQ","symbol":"INAB"}]}],"created":1732538884,"date":"2024-11-25","drug":{"generic":false,"id":"654e1f5b1e70180001da4a44","indication_symptom":["For the treatment of newly diagnosed GBM solid tumors. "],"name":"INB-200"},"event_type":"presented results","id":"67447204f5ad71000147f722","nic_number":"","notes":"","outcome":"IN8bio, Inc. , presented results from the fully enrolled Phase 1 trial of INB-200 in a plenary oral presentation at the 29th Annual Meeting of the Society for Neuro-Oncology in Houston, TX.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42160042/in8bio-reports-continued-durable-remissions-in-phase-1-trial-of-inb-200-in-plenary-oral-presentati","source_type":"Press Release","status":"Phase 1","target_date":"","time":"07:48:04","updated":1732538937},{"commentary":"","companies":[{"cik":"1178670","id":"603cef78b9e30d000188bc09","name":"Alnylam Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ALNY"}]}],"created":1732538755,"date":"2024-11-25","drug":{"generic":false,"id":"670e4e9c500eec0001a589aa","indication_symptom":["For the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with 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metastatic triple-negative breast cancer"],"name":"capivasertib"},"event_type":"Provided Update","id":"67446fe2f5ad71000147f646","nic_number":"","notes":"","outcome":"AstraZeneca announced that Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42160045/truqap-capivasertib-combination-in-pten-deficient-metastatic-hormone-sensitive-prostate-cancer-dem","source_type":"Press 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regimen.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42123154/replimune-receives-breakthrough-therapy-designation-for-rp1-and-submits-rp1-biologics-license-appl","source_type":"Press Release","status":"Biologics License Applications (BLA)","target_date":"","time":"06:51:15","updated":1732535587},{"commentary":"","companies":[{"cik":"310158","id":"603cef78b9e30d000188b9a4","name":"Merck \u0026 Co Inc","securities":[{"exchange":"NYSE","symbol":"MRK"}]}],"created":1732534875,"date":"2024-11-22","drug":{"generic":false,"id":"6501af9d9ab00f00016a4d18","indication_symptom":["Treated Patients With Advanced Renal Cell Carcinoma (RCC)"],"name":"belzutifan"},"event_type":"Provided Update","id":"6744625bf5ad71000147f353","nic_number":"","notes":"","outcome":"Merck announced that the National Medical Products Administration (NMPA) in China has approved WELIREG® (belzutifan), for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42134411/mercks-welireg-belzutifan-approved-in-china-for-the-treatment-of-adult-patients-with-certain-types","source_type":"Press Release","status":"China National Medical Products Administration (NMPA) Approval","target_date":"","time":"06:41:15","updated":1732534949},{"commentary":"","companies":[{"cik":"1095981","id":"603cef78b9e30d000188be73","name":"Plus Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"PSTV"}]}],"created":1732534777,"date":"2024-11-22","drug":{"generic":false,"id":"66b9fbd4157a570001811ced","indication_symptom":[" For the diagnosis and management of Leptomeningeal Metastases (LM)"],"name":"FORESEE"},"event_type":"Data 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","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42135442/plus-therapeutics-to-present-positive-foresee-clinical-trial-summary-demonstrating-utility-of-cnsi","source_type":"Press Release","status":"","target_date":"","time":"06:39:37","updated":1732534843},{"commentary":"","companies":[{"cik":"200406","id":"603cef79b9e30d000188c04b","name":"Johnson \u0026 Johnson","securities":[{"exchange":"NYSE","symbol":"JNJ"}]}],"created":1732534632,"date":"2024-11-22","drug":{"generic":false,"id":"65f15d2e9acba600013a34e7","indication_symptom":["For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis"],"name":"Guselkumab"},"event_type":"BLA Filing","id":"67446168f5ad71000147f300","nic_number":"","notes":"","outcome":"Johnson \u0026 Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active UC.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42136076/johnson-johnson-seeks-u-s-fda-approval-for-subcutaneous-induction-regimen-of-tremfya-guselkumab-in","source_type":"Press Release","status":"Biologics License Applications (BLA)","target_date":"","time":"06:37:12","updated":1732534722},{"commentary":"","companies":[{"cik":"1402328","id":"603cef7cb9e30d000188e3cd","name":"Sunshine Biopharma Inc","securities":[{"exchange":"OTC","symbol":"SBFM"}]}],"created":1732534400,"date":"2024-11-22","drug":{"generic":false,"id":"67445d9372fb4d00010df32b","indication_symptom":["For cholestatic liver diseases"," including primary biliary cirrhosis (PBC)"],"name":"URSO DS"},"event_type":"Provided Update","id":"67446080f5ad71000147f2c0","nic_number":"","notes":"","outcome":"Sunshine Biopharma Inc announced that its wholly owned Canadian subsidiary, Nora Pharma Inc., has launched a new generic prescription drug.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42136096/sunshine-biopharma-launches-a-new-generic-prescription-drug","source_type":"Press Release","status":"","target_date":"","time":"06:33:20","updated":1732534446},{"commentary":"","companies":[{"cik":"1041934","id":"603cef78b9e30d000188befc","name":"Edap TMS SA","securities":[{"exchange":"NASDAQ","symbol":"EDAP"}]}],"created":1732534245,"date":"2024-11-22","drug":{"generic":false,"id":"66fbdbe2c2ed5b00011d91c8","indication_symptom":["For the Treatment of Benign Prostatic Hyperplasia (BPH)"],"name":"Focal One"},"event_type":"Presentation","id":"67445fe5f5ad71000147f283","nic_number":"","notes":"","outcome":"EDAP TMS SA announced a scientific presentation which demonstrated the technical feasibility of performing non-thermal histotripsy energy delivery and generating histotripsy lesions in biological tissues ex vivo using the Company's Focal One® Robotic HIFU technology.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42136054/edap-announces-scientific-presentation-highlighting-feasibility-of-focal-one-to-perform-non-therma","source_type":"Press Release","status":"","target_date":"","time":"06:30:45","updated":1732534322},{"commentary":"","companies":[{"cik":"","id":"62d70a8affd4a7000153a563","name":"Humacyte, Inc.","securities":[{"exchange":"NASDAQ","symbol":"HUMA"}]}],"created":1732534173,"date":"2024-11-22","drug":{"generic":false,"id":"66a8dd3c2762310001537d33","indication_symptom":["For patients with end-stage renal disease."],"name":"V007"},"event_type":"presented results","id":"67445f9df5ad71000147f268","nic_number":"","notes":"","outcome":"Humacyte, announced that it will present Phase 3 results from a clinical study comparing efficacy and safety of Humacyte's acellular tissue engineered vessel (ATEV™) with autologous AV fistulas in patients with end stage renal disease at the 51st Annual Symposium on Vascular and Endovascular Issues, Techniques and Horizons (VEITH) in New York, NY on November 23, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42155558/rosen-a-global-and-leading-law-firm-encourages-humacyte-inc-investors-to-secure-counsel-before-imp","source_type":"Press Release","status":"Phase 3","target_date":"","time":"06:29:33","updated":1732534228},{"commentary":"","companies":[{"cik":"1671584","id":"603cef7eb9e30d000188f930","name":"Aptevo Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"APVO"}]},{"cik":"1654604","id":"603cef7eb9e30d000188f9bb","name":"Alligator Bioscience AB","securities":[{"exchange":"GREY","symbol":"ALLGF"}]}],"created":1732533846,"date":"2024-11-22","drug":{"generic":false,"id":"63285ad1cae9850001a915ab","indication_symptom":["5T4-expressing tumor antigens in multiple solid tumor types"],"name":"ALG.APV-527"},"event_type":"Provided 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Update","id":"67445d8872fb4d00010df31c","nic_number":"","notes":"","outcome":"Jaguar Health, Inc. announced that it is seeking a partner to fund and execute the development and commercialization of NP300, the company's prescription drug candidate for the treatment of general, non-infectious diarrhea in dogs, in exchange for commercial rights to the product in the U.S.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42137503/jaguar-health-seeking-partner-to-develop-and-commercialize-np300-second-generation-antisecretory-","source_type":"Press Release","status":"","target_date":"","time":"06:20:40","updated":1732533823},{"commentary":"","companies":[{"cik":"","id":"60589bcc36622a00016516f8","name":"Virpax Pharmaceuticals, Inc.","securities":[]}],"created":1732529833,"date":"2024-11-22","drug":{"generic":false,"id":"6058bbe136622a0001789621","indication_symptom":["Liposomal (Hydro) Gel Technology for postoperative pain 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Probudur is the company's long-acting liposomal bupivacaine formulation injected at a wound site to provide both immediate and extended pain relief.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42136987/virpax-announces-positive-results-for-the-swine-model-dose-range-finding-study-for-probudur","source_type":"Press Release","status":"","target_date":"","time":"05:17:13","updated":1732529951},{"commentary":"","companies":[{"cik":"1743881","id":"603cef7eb9e30d000188ff2c","name":"BridgeBio Pharma Inc","securities":[{"exchange":"NASDAQ","symbol":"BBIO"}]}],"created":1732528992,"date":"2024-11-22","drug":{"generic":false,"id":"61c9b863a7cbdc00017384c7","indication_symptom":["Symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM)"],"name":"Acoramidis (ATTRibute-CM)"},"event_type":"FDA Approval","id":"67444b602d72ce0001cb1c2d","nic_number":"","notes":"","outcome":"BridgeBio Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Attruby™ (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42150289/attruby-acoramidis-a-near-complete-ttr-stabilizer-90-approved-by-fda-to-reduce-cardiovascular-deat","source_type":"Press Release","status":"FDA Approved","target_date":"","time":"05:03:12","updated":1732529068},{"commentary":"","companies":[{"cik":"","id":"652d2de41c7d4600012beb78","name":"Perspective Therapeutics Inc","securities":[]}],"created":1732194009,"date":"2024-11-21","drug":{"generic":false,"id":"6565e90a2803140001e08ea4","indication_symptom":["For the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2)-expressing neuroendocrine tumors."],"name":"Pb-212"},"event_type":"Initial 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Pharmaceuticals, Inc. today announced groundbreaking preclinical results confirming the efficacy of Telomir-1, a compound designed to effectively turn back the biological clock and support longevity.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42108323/telomir-pharmaceuticals-confirms-age-reversal-increased-longevity-and-improved-healthspan-in-grou","source_type":"Press Release","status":"","target_date":"","time":"07:52:10","updated":1732193706},{"commentary":"","companies":[{"cik":"1232524","id":"603cef7ab9e30d000188d398","name":"Jazz Pharmaceuticals PLC","securities":[{"exchange":"NASDAQ","symbol":"JAZZ"}]}],"created":1732532984,"date":"2024-11-20","drug":{"generic":false,"id":"673dddfc759e09000119bdad","indication_symptom":["For the Treatment of Adults with Previously Treated"," Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)"],"name":"Ziihera"},"event_type":"Provided Update","id":"67445af872fb4d00010df2c2","nic_number":"","notes":"","outcome":"Jazz Pharmaceuticals plc announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42101689/jazz-pharmaceuticals-announces-u-s-fda-approval-of-ziihera-zanidatamab-hrii-for-the-treatment-of-a","source_type":"Press Release","status":"","target_date":"","time":"06:09:44","updated":1732533122},{"commentary":"","companies":[{"cik":"1348362","id":"603cef7bb9e30d000188db9d","name":"Lexaria Bioscience Corp","securities":[{"exchange":"NASDAQ","symbol":"LEXX"},{"exchange":"CNQ","symbol":"LXX"}]}],"created":1732114082,"date":"2024-11-20","drug":{"generic":false,"id":"6138a197b6abe40001f0374d","indication_symptom":["Hypertension"],"name":"DehydraTECH-CBD"},"event_type":"Results","id":"673df6a2759e09000119c93f","nic_number":"","notes":"","outcome":"Lexaria Bioscience Corp. announces that it has received final 12-week body weight and blood sugar results from all 12 study groups of the recently completed diabetes animal study WEIGHT-A24-1 (the \"Study\").","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42089015/all-study-groups-using-dehydratech-processing-outperform-rybelsus-r-in-body-weight-control-in-lex","source_type":"Press Release","status":"","target_date":"","time":"09:48:02","updated":1732114156},{"commentary":"","companies":[{"cik":"1401667","id":"603cef7db9e30d000188f066","name":"Puma Biotechnology Inc","securities":[{"exchange":"NASDAQ","symbol":"PBYI"}]}],"created":1732113739,"date":"2024-11-20","drug":{"generic":false,"id":"650c1e628345120001a3d0f1","indication_symptom":["For the Treatment of Small Cell Lung Cancer"],"name":"alisertib"},"event_type":"Trial Initiation","id":"673df54b56a2320001310f85","nic_number":"","notes":"","outcome":"Puma Biotechnology, Inc. announced the initiation of its ALISertib in CAncer (ALISCA™-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in combination with endocrine therapy for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast cancer who have been previously treated with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42088496/puma-biotechnology-announces-initiation-of-alisca-breast1-phase-ii-trial-of-alisertib-in-hormone-r","source_type":"Press Release","status":"Phase 2","target_date":"","time":"09:42:19","updated":1732113827},{"commentary":"","companies":[{"cik":"1595248","id":"603cef7eb9e30d000188fb0d","name":"Genprex Inc","securities":[{"exchange":"NASDAQ","symbol":"GNPX"}]}],"created":1732113530,"date":"2024-11-20","drug":{"generic":false,"id":"66deea6f6d02590001c8e41d","indication_symptom":["For the treatment of Ras inhibitor resistant lung cancer"," mesothelioma and glioblastoma."],"name":"Reqorsa® Gene Therapy"},"event_type":"Provided Update","id":"673df47aebb2e50001e7056d","nic_number":"","notes":"","outcome":"Genprex, Inc announced it has entered into an exclusive license agreement with the University of Michigan, granting Genprex a worldwide, exclusive license to the University's patent rights relating toits lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid), in combination with ALK-inhibitors for the potential treatment of ALK-EML4 positive translocated lung cancer.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42089950/genprex-signs-exclusive-license-to-additional-gene-therapy-technologies-with-the-university-of-mic","source_type":"Press Release","status":"","target_date":"","time":"09:38:50","updated":1732113660},{"commentary":"","companies":[{"cik":"","id":"613758f9b4035700018d2836","name":"RenovoRx, Inc.","securities":[{"exchange":"NASDAQ","symbol":"RNXT"}]}],"created":1732110793,"date":"2024-11-20","drug":{"generic":false,"id":"613758c4b4035700018d2824","indication_symptom":["Solid Tumors"],"name":"RenovoCath"},"event_type":"Enrollment Update","id":"673de9c9ebb2e50001e7013e","nic_number":"","notes":"","outcome":"RenovoRx, Inc. announced today that the Northwell Health Cancer Institute (\"NHCI\") in New Hyde Park, NY is enrolling patients with locally advanced pancreatic cancer (LAPC) in the Company's ongoing pivotal Phase III TIGeR-PaC clinical trial.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42088158/northwell-health-cancer-institute-launches-patient-enrollment-in-renovorxs-ongoing-pivotal-phase-i","source_type":"Press Release","status":"","target_date":"","time":"08:53:13","updated":1732110834},{"commentary":"","companies":[{"cik":"1801834","id":"603cef7fb9e30d0001890182","name":"PainReform Ltd","securities":[{"exchange":"NASDAQ","symbol":"PRFX"}]}],"created":1732109583,"date":"2024-11-20","drug":{"generic":false,"id":"647f0f32b6bcbf0001d45711","indication_symptom":["To provide localized and extended post-operative analgesia."],"name":"PRF-110"},"event_type":"Provided Update","id":"673de50febb2e50001e70107","nic_number":"","notes":"","outcome":"PainReform Ltd. announced the receipt of partial topline data from its contract research organization (CRO), Lotus Clinical Research (\"Lotus\"), for the Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42087580/painreform-announces-initial-topline-data-for-prf-110-phase-3-clinical-trial","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:33:03","updated":1732109625},{"commentary":"","companies":[{"cik":"1613103","id":"603cef78b9e30d000188b99c","name":"Medtronic PLC","securities":[{"exchange":"NYSE","symbol":"MDT"}]}],"created":1732109477,"date":"2024-11-20","drug":{"generic":false,"id":"60ae6b33dbe0bc000145a26a","indication_symptom":["Smart insulin pen for multiple daily injections (MDI)"],"name":"InPen"},"event_type":"FDA Clearance","id":"673de4a5ebb2e50001e700f6","nic_number":"","notes":"","outcome":"Medtronic plc announced U.S. Food and Drug Administration (FDA) clearance for its new InPen™ app featuring missed meal dose detection, paving the way for the launch of its Smart MDI system with the Simplera™ continuous glucose monitor (CGM).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42087606/medtronic-receives-fda-clearance-for-new-inpen-app-paving-the-way-for-its-smart-mdi-system-launch-","source_type":"Press Release","status":"","target_date":"","time":"08:31:17","updated":1732109531},{"commentary":"","companies":[{"cik":"1497253","id":"603cef7db9e30d000188ebed","name":"Organovo Holdings Inc","securities":[{"exchange":"NASDAQ","symbol":"ONVO"}]}],"created":1732108631,"date":"2024-11-20","drug":{"generic":false,"id":"64cb8a8e0a40e5000113d298","indication_symptom":["Treatment of ulcerative colitis"],"name":"FXR314"},"event_type":"Oral presentation","id":"673de157ebb2e50001e700d7","nic_number":"","notes":"","outcome":"Organovo Holdings, Inc. announces that its oral presentation of its lead clinical stage drug FXR314 by Dr. Eric Lawitz of the Texas Liver Institute and the University of Texas Health San Antonio was featured at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42086576/organovo-presents-clinical-data-of-fxr314-in-phase-2-mash-in-an-oral-presentation-at-the-liver-mee","source_type":"Press Release","status":"","target_date":"","time":"08:17:11","updated":1732108683},{"commentary":"","companies":[{"cik":"744218","id":"603cef78b9e30d000188bda0","name":"Celldex Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"CLDX"}]}],"created":1732107761,"date":"2024-11-20","drug":{"generic":false,"id":"673dddfd759e09000119bdaf","indication_symptom":["For the Treatment of Inflammatory Diseases"],"name":"CDX-622"},"event_type":"Dose Update","id":"673dddf1759e09000119bda9","nic_number":"","notes":"","outcome":"Celldex Therapeutics, Inc. announced that the first patient has been dosed in the Company's Phase 1a study of CDX-622 in healthy volunteers.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42086431/celldex-announces-first-patient-dosed-in-phase-1-healthy-volunteer-study-of-cdx-622-a-bispecific-a","source_type":"Press Release","status":"Phase 1a","target_date":"","time":"08:02:41","updated":1732107852},{"commentary":"","companies":[{"cik":"1580149","id":"603cef7db9e30d000188f40a","name":"BioVie Inc","securities":[{"exchange":"NASDAQ","symbol":"BIVI"}]}],"created":1732107669,"date":"2024-11-20","drug":{"generic":false,"id":"664de51a5c436000019edc65","indication_symptom":["For Parkinson's Disease Patients"],"name":"Bezisterim"},"event_type":"Abstract","id":"673ddd95759e09000119bd7a","nic_number":"","notes":"","outcome":"BioVie Inc. announced that an abstract on the design of its planned Phase 2 trial evaluating bezisterim in Long COVID has been accepted as a poster presentation at the Demystifying Long COVID International Conference, November 21st \u0026 22nd 2024, in Barcelona Spain.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42086252/biovie-to-present-design-of-planned-phase-2-study-of-bezisterim-for-the-treatment-of-long-covid-at","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:01:09","updated":1732107722},{"commentary":"","companies":[{"cik":"1624326","id":"603cef7eb9e30d000188f6f3","name":"PAVmed Inc","securities":[{"exchange":"NASDAQ","symbol":"PAVM"}]}],"created":1732107473,"date":"2024-11-20","drug":{"generic":false,"id":"673ddcf06295c70001ba4d40","indication_symptom":["For EsoGuard® Esophageal DNA Test"],"name":"MolDX"},"event_type":"Provided Update","id":"673ddcd16295c70001ba4d2f","nic_number":"","notes":"","outcome":"Lucid Diagnostics subsidiary of PAVmed Inc. announced that it has submitted its complete clinical evidence package for its EsoGuard® Esophageal DNA Test in support of a Request for Reconsideration of Local Coverage Determination (LCD) L39256 \"MolDX: Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia\" to Molecular Diagnostics Program (MolDX), administered by Palmetto GBA, a Medicare Administrative Contractor (MAC) for the Centers for Medicare \u0026 Medicaid Services (CMS), to seek coverage for EsoGuard.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42086151/lucid-diagnostics-submits-clinical-evidence-package-to-moldx-seeking-medicare-coverage-for-esoguar","source_type":"Press Release","status":"","target_date":"","time":"07:57:53","updated":1732107625},{"commentary":"","companies":[{"cik":"","id":"65268d813b3e380001943dff","name":"ZyVersa Therapeutics Inc","securities":[]}],"created":1732107415,"date":"2024-11-20","drug":{"generic":false,"id":"650c1e628345120001a3d0ef","indication_symptom":["For Obesity-related Heart Disease"],"name":"IC 100"},"event_type":"Data Publication","id":"673ddc976295c70001ba4d1c","nic_number":"","notes":"","outcome":"ZyVersa Therapeutics, Inc announces newly published data demonstrating that stroke-related cardiovascular injury and dysfunction is induced by AIM2 inflammasome activation and pyroptosis in the heart, which can be blocked by Inflammasome ASC Inhibitor IC 100..","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42086144/zyversa-therapeutics-announces-peer-reviewed-publication-demonstrating-that-inflammasome-asc-inhib","source_type":"Press Release","status":"","target_date":"","time":"07:56:55","updated":1732107454},{"commentary":"","companies":[{"cik":"1904286","id":"667419e95b3ba10001e3dcab","name":"MIRA PHARMACEUTICALS, INC.","securities":[{"exchange":"NASDAQ","symbol":"MIRA"}]}],"created":1732107093,"date":"2024-11-20","drug":{"generic":false,"id":"6666eea6b531ba0001990fb9","indication_symptom":["To treat depression and treatment-resistant depression (TRD)."],"name":"Ketamir-2"},"event_type":"Provided Update","id":"673ddb556295c70001ba4cfe","nic_number":"","notes":"","outcome":"MIRA Pharmaceuticals, Inc. is pleased to announce the selection of The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42086027/mira-reveals-innovative-phase-iiia-protocol-design-and-selection-of-clinical-trial-site","source_type":"Press Release","status":"","target_date":"","time":"07:51:33","updated":1732107167},{"commentary":"","companies":[{"cik":"1372299","id":"603cef7db9e30d000188f5da","name":"Ocugen Inc","securities":[{"exchange":"NASDAQ","symbol":"OCGN"}]}],"created":1732106961,"date":"2024-11-20","drug":{"generic":false,"id":"65520063207b9d0001912b42","indication_symptom":["For Stargardt Disease"],"name":"OCU410ST"},"event_type":"Designation Grant","id":"673ddad16295c70001ba4cdf","nic_number":"","notes":"","outcome":"- Ocugen, Inc. announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod dystrophy 3 (CORD3).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42085510/ocugen-announces-european-medicines-agency-grants-orphan-medicinal-product-designation-for-modifie","source_type":"Press Release","status":"orphan medicinal product designation","target_date":"","time":"07:49:21","updated":1732107033},{"commentary":"","companies":[{"cik":"882361","id":"603cef78b9e30d000188b93f","name":"Aptose Biosciences Inc","securities":[{"exchange":"TSE","symbol":"APS"},{"exchange":"NASDAQ","symbol":"APTO"}]}],"created":1732106002,"date":"2024-11-20","drug":{"generic":false,"id":"6482dc38fdfac50001750d1b","indication_symptom":["Tuspetinib is a potent inhibitor of FLT3"," SYK"," cKITMUT"," JAK"," and other kinases"],"name":"tuspetinib"},"event_type":"Study Initiation","id":"673dd7126295c70001ba4cca","nic_number":"","notes":"","outcome":"Aptose Biosciences Inc nnounced initiation of the TUSCANY study, tuspetinib (TUS) in combination therapy with azacitidine (AZA) and venetoclax (VEN) as a frontline triplet combination therapy for patients newly diagnosed with acute myeloid leukemia, or AML. The trial is being conducted at multiple U.S. clinical sites.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42085504/aptose-initiates-tuscany-phase-12-study-for-newly-diagnosed-aml-patients-to-receive-tuspetinib-bas","source_type":"Press Release","status":"","target_date":"","time":"07:33:22","updated":1732106048},{"commentary":"","companies":[{"cik":"","id":"656745222803140001e0b455","name":"Pasithea Therapeutics Corp","securities":[]}],"created":1732105205,"date":"2024-11-20","drug":{"generic":false,"id":"656733737f07f10001caf23b","indication_symptom":["Allosteric inhibitor of MEK 1/2"],"name":"PAS-004"},"event_type":"Recommendation","id":"673dd3f56295c70001ba4c56","nic_number":"","notes":"","outcome":"Pasithea Therapeutics Corp. announced that the external Safety Review Committee recommended proceeding to cohort 4, 15mg capsule, without modifications.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42084781/pasithea-therapeutics-announces-positive-safety-review-committee-src-recommendation-from-its-ongoi","source_type":"Press Release","status":"","target_date":"","time":"07:20:05","updated":1732105251},{"commentary":"","companies":[{"cik":"","id":"664c5fb857d42200014c051e","name":"NewAmsterdam Pharma Company N.V","securities":[{"exchange":"NASDAQ","symbol":"NAMS"}]}],"created":1732104900,"date":"2024-11-20","drug":{"generic":false,"id":"673dd2e7ebb2e50001e70053","indication_symptom":["In Patients with ASCVD or ASCVD Risk Factors and/or HeFH"],"name":"TANDEM"},"event_type":"Top-line data","id":"673dd2c4ebb2e50001e70050","nic_number":"","notes":"","outcome":"NewAmsterdam Pharma Company N.V. announced positive topline data from the Company's Phase 3 TANDEM clinical trial (NCT06005597). TANDEM will support global regulatory filings for the 10 mg obicetrapib and 10 mg ezetimibe fixed-dose combination in adult patients with heterozygous familial hypercholesterolemia (\"HeFH\") and/or atherosclerotic cardiovascular disease (\"ASCVD\") or multiple ASCVD risk factors, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42084630/newamsterdam-pharma-announces-positive-topline-data-from-pivotal-phase-3-tandem-clinical-trial-eva","source_type":"Press Release","status":"Phase 3","target_date":"","time":"07:15:00","updated":1732105152},{"commentary":"","companies":[{"cik":"","id":"66fd3d3a6d02590001cc1505","name":"CytoMed Therapeutics Limited","securities":[{"exchange":"NASDAQ","symbol":"GDTC"}]}],"created":1732102890,"date":"2024-11-20","drug":{"generic":false,"id":"6703c6f4a88f220001ad62ee","indication_symptom":["allogeneic chimeric antigen 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Inhibitors"],"name":"HYMPAVZI"},"event_type":"Marketing authorization","id":"673da59856a23200013101e9","nic_number":"","notes":"","outcome":"Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for HYMPAVZI™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42082227/european-commission-approves-pfizers-hympavzi-marstacimab-for-the-treatment-of-adults-and-adolesce","source_type":"Press Release","status":"","target_date":"","time":"04:02:16","updated":1732093394},{"commentary":"","companies":[{"cik":"1697862","id":"603cef7db9e30d000188f551","name":"argenx SE","securities":[{"exchange":"GREY","symbol":"ARGNF"},{"exchange":"NASDAQ","symbol":"ARGX"}]}],"created":1732083311,"date":"2024-11-20","drug":{"generic":false,"id":"673d7eafebb2e50001e6fd74","indication_symptom":["In Idiopathic Inflammatory Myopathies"],"name":"ALKIVIA"},"event_type":"Provided Update","id":"673d7e6febb2e50001e6fd69","nic_number":"","notes":"","outcome":"argenx SE announced the decision to continue development of efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in the ongoing Phase 2/3 ALKIVIA study in adults with idiopathic inflammatory myopathies (IIM or myositis),","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42080684/argenx-advances-clinical-development-of-efgartigimod-sc-in-idiopathic-inflammatory-myopathies","source_type":"Press Release","status":"Phase 2/3","target_date":"","time":"01:15:11","updated":1732083510},{"commentary":"","companies":[{"cik":"1001233","id":"603cef78b9e30d000188baef","name":"Sangamo Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"SGMO"}]}],"created":1732052874,"date":"2024-11-19","drug":{"generic":false,"id":"673bae2b759e090001196345","indication_symptom":["For the Treatment of Idiopathic Small Fiber Neuropathy"," a Type of Chronic Neuropathic Pain"],"name":"ST-503"},"event_type":"FDA Clearance","id":"673d078a56a232000130efeb","nic_number":"","notes":"","outcome":"Sangamo Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for its ST-503 program, an investigational epigenetic regulator for the treatment of intractable pain due to idiopathic small fiber neuropathy (iSFN), a type of chronic neuropathic pain.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42074698/sangamo-therapeutics-announces-u-s-fda-clearance-of-ind-application-for-st-503-for-the-treatment-o","source_type":"Press Release","status":"Investigational New Drug (IND)","target_date":"","time":"16:47:54","updated":1732053893},{"commentary":"","companies":[{"cik":"1607678","id":"603cef7db9e30d000188f53a","name":"Viking Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"VKTX"}]}],"created":1732052875,"date":"2024-11-19","drug":{"generic":false,"id":"673bae2b759e090001196347","indication_symptom":["In Biopsy-Confirmed NASH/MASH"],"name":"VK2809"},"event_type":"Results","id":"673d078b56a232000130efed","nic_number":"","notes":"","outcome":"Viking Therapeutics, Inc announced that final results from the company's Phase 2b clinical trial of VK2809, the company's novel liver-selective thyroid hormone receptor beta agonist, in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred to as metabolic dysfunction associated steatohepatitis, MASH) were highlighted in an oral late breaker presentation at the 75th Liver Meeting® 2024, the annual meeting of the American Association for the Study of Liver Disease (AASLD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42074118/viking-therapeutics-presents-results-from-phase-2b-voyage-study-of-vk2809-in-biopsy-confirmed-nash","source_type":"Press Release","status":"Phase 2b","target_date":"","time":"16:47:55","updated":1732053428},{"commentary":"","companies":[{"cik":"1281895","id":"603cef7db9e30d000188f5fe","name":"Rocket Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"RCKT"}]}],"created":1732052875,"date":"2024-11-19","drug":{"generic":false,"id":"611a588fb6abe40001ee361b","indication_symptom":["Danon Disease"],"name":"RP-A501"},"event_type":"Efficacy and Safety Data","id":"673d078b56a232000130efef","nic_number":"","notes":"","outcome":"Rocket Pharmaceuticals, Inc presented long-term safety and efficacy results from the Phase 1 study of RP-A501 in male patients with Danon disease.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42041162/rocket-pharmaceuticals-announces-new-england-journal-of-medicine-publication-of-phase-1-rp-a501-lo","source_type":"Press Release","status":"","target_date":"","time":"16:47:55","updated":1732053027},{"commentary":"","companies":[{"cik":"1799448","id":"603cef7fb9e30d00018902a8","name":"Aligos Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"ALGS"}]}],"created":1732052875,"date":"2024-11-19","drug":{"generic":false,"id":"6076df836d58b1000199fed5","indication_symptom":["Hepatitis B"],"name":"ALG-000184"},"event_type":"Positive Data","id":"673d078b56a232000130eff1","nic_number":"","notes":"","outcome":"Aligos Therapeutics, Inc announced positive data from one late-breaker oral and three poster presentations at the American Association for the Study of Liver Disease's (AASLD) The Liver Meeting (TLM) 2024, being held November 15 – 19, 2024 in San Diego, CA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42071253/aligos-therapeutics-presents-positive-data-at-the-liver-meeting-tlm-2024","source_type":"Press Release","status":"","target_date":"","time":"16:47:55","updated":1732052932},{"commentary":"","companies":[{"cik":"1625297","id":"603cef7db9e30d000188f60c","name":"Indivior PLC","securities":[{"exchange":"OTC","symbol":"INVVY"},{"exchange":"OTC","symbol":"IZQVF"}]}],"created":1732052568,"date":"2024-11-19","drug":{"generic":false,"id":"6703c6f3a88f220001ad62e6","indication_symptom":[" For the treatment of moderate to severe opioid use disorder "],"name":"SUBLOCADE"},"event_type":"Provided Update","id":"673d065856a232000130ef57","nic_number":"","notes":"","outcome":"Indivior PLC last week shared results from a randomized, open-label sub-study in opioid-dependent participants seeking treatment, (NCT04995029) that demonstrates rapid initiation (RI) with SUBLOCADE® (buprenorphine extended-release injection) for the treatment of OUD significantly improves treatment retention compared to standard initiation (SI).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42070335/rapid-initiation-with-once-monthly-sublocade-superior-to-standard-initiation-for-treating-opioid-u","source_type":"Press Release","status":"","target_date":"","time":"16:42:48","updated":1732052654},{"commentary":"","companies":[{"cik":"59478","id":"603cef78b9e30d000188b783","name":"Eli Lilly and Co","securities":[{"exchange":"NYSE","symbol":"LLY"}]}],"created":1732052363,"date":"2024-11-19","drug":{"generic":false,"id":"66f12e74c2ed5b00011c6c4e","indication_symptom":["For atopic dermatitis"],"name":"EBGLYSS"},"event_type":"Provided Update","id":"673d058b56a232000130ef04","nic_number":"","notes":"","outcome":"Eli Lilly Canada Inc. announced that it is disappointed and strongly disagrees with Canada's Drug Agency (CDA-AMC)'s Final Recommendation for Ebglyss™ (lebrikizumab), published on Friday, November 15, 2024.","outcome_brief":"","source_link":"https://www.newswire.ca/news-releases/lilly-canada-remains-steadfast-in-commitment-to-access-options-for-patients-amidst-controversial-cda-amc-recommendation-for-ebglyss-tm-lebrikizumab--887709623.html","source_type":"Other","status":"","target_date":"","time":"16:39:23","updated":1732052442},{"commentary":"","companies":[{"cik":"","id":"606b65f2653896000188fe31","name":"IceCure Medical Ltd","securities":[]}],"created":1732023595,"date":"2024-11-19","drug":{"generic":false,"id":"606b657c653896000188fe0f","indication_symptom":["T1 invasive breast cancer and/or patients not suitable for surgical alternatives for the treatment of breast cancer"],"name":"ProSense Cryoablation System"},"event_type":"Provided Update","id":"673c952bcb444a000172bb5e","nic_number":"","notes":"","outcome":"IceCure Medical Ltd. announced the publication of an article titled \"Cryoablation of early breast cancer: the challenge towards de-escalation of surgical treatment\" in the European Journal of Cancer Prevention.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42061903/icecures-prosense-chosen-for-breast-cryoablation-study-led-by-the-prestigious-european-institute-o","source_type":"Press Release","status":"","target_date":"","time":"08:39:55","updated":1732024167},{"commentary":"","companies":[{"cik":"","id":"65d4b05afd3dd800013d8691","name":"enVVeno Medical Corporation","securities":[]},{"cik":"1661053","id":"603cef7eb9e30d000188fb40","name":"Hancock Jaffe Laboratories Inc","securities":[{"exchange":"NASDAQ","symbol":"HJLI"}]}],"created":1732023432,"date":"2024-11-19","drug":{"generic":false,"id":"60468aafe74cfd00012cae05","indication_symptom":["Chronic Venous Insufficiency (CVI)"],"name":"VenoValve"},"event_type":"Application Submitted","id":"673c9488cb444a000172bb2b","nic_number":"","notes":"","outcome":"enVVeno Medical Corporation announced it has submitted its application with the U.S. Food and Drug Administration (FDA) seeking approval to market and sell the VenoValve in the United States. Four (4) out of five (5) modules that comprise the VenoValve PMA application have been submitted, reviewed and approved by the FDA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42061288/envveno-medical-submits-the-venovalve-pma-application-seeking-fda-approval","source_type":"Press Release","status":"","target_date":"","time":"08:37:12","updated":1732023524},{"commentary":"","companies":[{"cik":"946644","id":"603cef78b9e30d000188bf67","name":"AIM ImmunoTech Inc","securities":[{"exchange":"AMEX","symbol":"AIM"}]}],"created":1732022176,"date":"2024-11-19","drug":{"generic":false,"id":"608811d2eb87ad000173bac0","indication_symptom":["COVID-19 and Other Respiratory Viral Diseases"],"name":"Ampligen"},"event_type":"Data Publication","id":"673c8fa0cb444a000172b921","nic_number":"","notes":"","outcome":"AIM ImmunoTech Inc. announced that data were published on Roswell Park Comprehensive Cancer Center's Phase 1 study evaluating AIM ImmunoTech's drug Ampligen® (also known as rintatolimod) as a component of a chemokine-modulating (CKM) regimen in early-stage triple-negative breast cancer (TNBC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42060421/aim-immunotech-announces-publication-of-breast-cancer-data-from-roswell-park-comprehensive-cancer-","source_type":"Press Release","status":"Phase 1","target_date":"","time":"08:16:16","updated":1732022250},{"commentary":"","companies":[{"cik":"","id":"604b6ab736622a000186b725","name":"ImmunityBio Inc","securities":[]}],"created":1732022061,"date":"2024-11-19","drug":{"generic":false,"id":"66741da672eac3000118a586","indication_symptom":[" For Bacillus Calmette-Guérin "],"name":"ANKTIVA"},"event_type":"New Data","id":"673c8f2dcb444a000172b8fd","nic_number":"","notes":"","outcome":"ImmunityBio, Inc announced compelling new data from its ongoing QUILT 3.032 study.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42060582/immunitybio-completes-anktivas-post-approval-enrollment-of-the-100th-patient-in-bcg-unresponsive-n","source_type":"Press Release","status":"","target_date":"","time":"08:14:21","updated":1732022124},{"commentary":"","companies":[{"cik":"811222","id":"603cef7bb9e30d000188db4b","name":"Cardiff Lexington Corp","securities":[{"exchange":"OTC","symbol":"CDIX"}]}],"created":1732021969,"date":"2024-11-19","drug":{"generic":false,"id":"6074408d2290f10001a7e828","indication_symptom":["Second line KRAS-mutated metastatic colorectal cancer (mCRC)"],"name":"Onvansertib + FOLFIRI + Avastin (Bevacizumab)"},"event_type":"Regulatory Update","id":"673c8ed1cb444a000172b8aa","nic_number":"","notes":"","outcome":"Cardiff Oncology, Inc announced the United States Patent and Trademark Office (USPTO) has issued to Cardiff Oncology U.S. patent No. 12,144,813 with an expected expiration date of no earlier than 2043.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42060476/cardiff-oncology-announces-new-patent-with-claims-for-the-use-of-onvansertib-in-treating-kras-muta","source_type":"Press Release","status":"","target_date":"","time":"08:12:49","updated":1732022035},{"commentary":"","companies":[{"cik":"1438569","id":"603cef7bb9e30d000188d82f","name":"Grifols SA","securities":[{"exchange":"OTC","symbol":"GIFLF"},{"exchange":"OTC","symbol":"GIFOF"},{"exchange":"OTC","symbol":"GIKLY"},{"exchange":"NASDAQ","symbol":"GRFS"}]}],"created":1732021791,"date":"2024-11-19","drug":{"generic":false,"id":"66a8dd3c2762310001537d31","indication_symptom":["For HBV Treatment"],"name":"Recombinant Polyclonal"},"event_type":"Dose Update","id":"673c8e1fcb444a000172b831","nic_number":"","notes":"","outcome":"GigaGen Inc., announced hat the first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of the first recombinant polyclonal drug candidate, GIGA-2339, for the treatment of hepatitis B virus (HBV) infection.","outcome_brief":"","source_link":"https://finance.yahoo.com/news/gigagen-doses-first-patient-phase-130000189.html","source_type":"Other","status":"Phase 1","target_date":"","time":"08:09:51","updated":1732021947},{"commentary":"","companies":[{"cik":"1763950","id":"603cef7fb9e30d00018900f9","name":"Lantern Pharma Inc","securities":[{"exchange":"NASDAQ","symbol":"LTRN"}]}],"created":1732021715,"date":"2024-11-19","drug":{"generic":false,"id":"62d00c5fa928500001b5674d","indication_symptom":["Never Smokers with Non-Small Cell Lung Cancer (NSCLC)"],"name":"LP-300 + Chemotherapy (Harmonic)"},"event_type":"Dose Update","id":"673c8dd3cb444a000172b7f4","nic_number":"","notes":"","outcome":"Lantern Pharma Inc announced that the first patient has been dosed – as part of the expansion cohort – in Japan for its Phase 2 HARMONIC™ clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42060655/lantern-pharma-announces-first-patient-dosed-in-japan-for-the-expansion-cohort-in-the-phase-2-harm","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:08:35","updated":1732021770},{"commentary":"","companies":[{"cik":"1533040","id":"603cef7db9e30d000188f0b6","name":"Phio Pharmaceuticals Corp","securities":[{"exchange":"NASDAQ","symbol":"PHIO"}]}],"created":1732021635,"date":"2024-11-19","drug":{"generic":false,"id":"6052613f8b500900017a0e95","indication_symptom":["Murine colorectal cancer"],"name":"PH-762 (INTASYL)"},"event_type":"Enrollment Update","id":"673c8d83cb444a000172b7bc","nic_number":"","notes":"","outcome":"Phio Pharmaceuticals Corp. announced it has completed the enrollment of its second patient cohort in its PH-762 Phase 1b dose-escalating clinical trial, and added a sixth clinical site in San Diego, CA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/42060026/phio-pharmaceuticals-announces-completion-of-enrollment-in-second-cohort-in-phase-1b-dose-escalatin","source_type":"Press Release","status":"Phase 1b","target_date":"","time":"08:07:15","updated":1732021681},{"commentary":"","companies":[{"cik":"812796","id":"603cef78b9e30d000188bec5","name":"Soligenix Inc","securities":[{"exchange":"NASDAQ","symbol":"SNGX"}]}],"created":1732021546,"date":"2024-11-19","drug":{"generic":false,"id":"656d9272a571ee0001ee9cbe","indication_symptom":["In the treatment of cutaneous T-cell lymphoma (CTCL) "],"name":"HyBryte"},"event_type":"Regulatory Update","id":"673c8d2acb444a000172b799","nic_number":"","notes":"","outcome":"Soligenix, Inc announced the formation of a European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42059694/soligenix-announces-formation-of-european-medical-advisory-board-for-cutaneous-t-cell-lymphoma","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:05:46","updated":1732021609},{"commentary":"","companies":[{"cik":"","id":"60ddb25528baa50001aa9e5f","name":"Alzamend Neuro, Inc.","securities":[{"exchange":"NASDAQ","symbol":"ALZN"}]},{"cik":"1653087","id":"603cef7eb9e30d000188fe5c","name":"Alector Inc","securities":[{"exchange":"NASDAQ","symbol":"ALEC"}]}],"created":1732021475,"date":"2024-11-19","drug":{"generic":false,"id":"6516c5db9705270001e211c6","indication_symptom":["A Next-Generation Lithium Therapeutic Drug Candidate"," in Bipolar Disorder 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(PSC)"},"event_type":"Data","id":"673c80cecb444a000172af5b","nic_number":"","notes":"","outcome":"Chemomab Therapeutics announced that data from its Phase 2 SPRING trial in patients with primary sclerosing cholangitis (PSC) was presented at the American Association for the Study of Liver Disease (AASLD) The Liver Meeting® 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42058770/oral-presentation-at-aasld-the-liver-meeting-2024-highlights-broad-clinical-activity-of-chemomabs-","source_type":"Press Release","status":"Phase 2","target_date":"","time":"07:13:02","updated":1732018470},{"commentary":"","companies":[{"cik":"1372299","id":"603cef7db9e30d000188f5da","name":"Ocugen Inc","securities":[{"exchange":"NASDAQ","symbol":"OCGN"}]}],"created":1732018198,"date":"2024-11-19","drug":{"generic":false,"id":"616f90633abe8b00016aad81","indication_symptom":["Dry Age-related Macular Degeneration (Dry AMD)"],"name":"OCU410"},"event_type":"Efficacy and Safety Data","id":"673c8016cb444a000172af22","nic_number":"","notes":"","outcome":"Ocugen, Inc announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42058951/ocugen-announces-compelling-preliminary-data-for-ocu410-a-single-dose-novel-modifier-gene-therapy-","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"07:09:58","updated":1732018250},{"commentary":"","companies":[{"cik":"310158","id":"603cef78b9e30d000188b9a4","name":"Merck \u0026 Co Inc","securities":[{"exchange":"NYSE","symbol":"MRK"}]}],"created":1732017223,"date":"2024-11-19","drug":{"generic":false,"id":"673bae2b759e090001196349","indication_symptom":[" For the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)."],"name":"MK-3475A-D77"},"event_type":"Top-line results","id":"673c7c476295c70001ba0614","nic_number":"","notes":"","outcome":"Merck announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, Merck's anti-PD-1 therapy, available for intravenous use as KEYTRUDA®, together with berahyaluronidase alfa, a hyaluronidase variant developed and manufactured by Alteogen Inc.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42058324/merck-announces-phase-3-trial-of-subcutaneous-pembrolizumab-with-berahyaluronidase-alfa-met-primar","source_type":"Press Release","status":"Phase 3","target_date":"","time":"06:53:43","updated":1732017486},{"commentary":"","companies":[{"cik":"875045","id":"603cef7ab9e30d000188ce54","name":"Biogen Inc","securities":[{"exchange":"NASDAQ","symbol":"BIIB"}]}],"created":1732002792,"date":"2024-11-19","drug":{"generic":false,"id":"66f12e75c2ed5b00011c6c5a","indication_symptom":["In Systemic Lupus Erythematosus "],"name":"dapirolizumab pegol"},"event_type":"Results","id":"673c43e8cb444a000172ab0b","nic_number":"","notes":"","outcome":"UCB and Biogen Inc. today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42054524/dapirolizumab-pegol-phase-3-data-presented-at-the-american-college-of-rheumatology-shows-significa","source_type":"Press Release","status":"Phase 3","target_date":"","time":"02:53:12","updated":1732002855},{"commentary":"","companies":[{"cik":"1598599","id":"603cef7bb9e30d000188d70c","name":"Innate Pharma SA","securities":[{"exchange":"NASDAQ","symbol":"IPHA"},{"exchange":"OTC","symbol":"IPHYF"}]}],"created":1732002595,"date":"2024-11-19","drug":{"generic":false,"id":"673bae2b759e09000119634b","indication_symptom":[" In B-cell non-Hodgkin lymphoma (B-NHL) "],"name":"IPH6501"},"event_type":"Publication","id":"673c4323cb444a000172aaf0","nic_number":"","notes":"","outcome":"Innate Pharma SA announced the publication in Science Immunology of preclinical data demonstrating the potential of IPH6501, Innate's proprietary NK cell engager including an IL-2v and targeting CD20 from the ANKET® platform.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42054511/innate-pharma-announces-publication-in-science-immunology-highlighting-innovative-next-generation-","source_type":"Press Release","status":"","target_date":"","time":"02:49:55","updated":1732002777},{"commentary":"","companies":[{"cik":"879169","id":"603cef79b9e30d000188bfd2","name":"Incyte Corp","securities":[{"exchange":"NASDAQ","symbol":"INCY"}]}],"created":1731964952,"date":"2024-11-18","drug":{"generic":false,"id":"673bae2c759e09000119634f","indication_symptom":["In chronic spontaneous urticaria"],"name":"MRGPRX2"},"event_type":"Enrollment Update","id":"673bb0186295c70001b9fc21","nic_number":"","notes":"","outcome":"Incyte announced that it will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42049159/incyte-provides-update-on-early-phase-mrgprx2-and-mrgprx4-programs","source_type":"Press Release","status":"","target_date":"","time":"16:22:32","updated":1731966181},{"commentary":"","companies":[{"cik":"200406","id":"603cef79b9e30d000188c04b","name":"Johnson \u0026 Johnson","securities":[{"exchange":"NYSE","symbol":"JNJ"}]}],"created":1731964953,"date":"2024-11-18","drug":{"generic":false,"id":"657898bca2fb150001c948e5","indication_symptom":["Severely Active Ulcerative Colitis"],"name":"JNJ-2113"},"event_type":"Positive Results","id":"673bb0196295c70001b9fc23","nic_number":"","notes":"","outcome":"Johnson \u0026 Johnson announced positive topline results from ICONIC-LEADa, a pivotal Phase 3 investigational study of icotrokinra (JNJ-2113), the first targeted oral peptide that selectively blocks the IL-23 receptor, in adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis (PsO).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42049164/icotrokinra-delivered-an-industry-leading-combination-of-significant-skin-clearance-with-demonstra","source_type":"Press Release","status":"Phase 3","target_date":"","time":"16:22:33","updated":1731966043},{"commentary":"","companies":[{"cik":"1706431","id":"603cef7eb9e30d000188ffc2","name":"Vir Biotechnology Inc","securities":[{"exchange":"NASDAQ","symbol":"VIR"}]}],"created":1731964953,"date":"2024-11-18","drug":{"generic":false,"id":"667bf66b38892b0001d8290d","indication_symptom":["For the Treatment of Chronic Hepatitis Delta Infection"],"name":"Tobevibart and Elebsiran"},"event_type":"Positive Opinion","id":"673bb0196295c70001b9fc25","nic_number":"","notes":"","outcome":"Vir Biotechnology, Inc announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has issued a positive opinion on the application for orphan drug designation of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42048280/vir-biotechnology-receives-positive-opinion-on-orphan-drug-designation-for-tobevibart-and-elebsira","source_type":"Press Release","status":"European Medicines Agency (EMA)","target_date":"","time":"16:22:33","updated":1731965105},{"commentary":"","companies":[{"cik":"1720580","id":"603cef7fb9e30d000189010e","name":"Adicet Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"ACET"}]}],"created":1731964029,"date":"2024-11-18","drug":{"generic":false,"id":"646365b82ab4640001a8b04d","indication_symptom":["An Armored Allogeneic \"Off-the-Shelf\" CAR gamma delta T Cell therapy Targeting CD70+ Cancers"],"name":"ADI-270"},"event_type":"Enrollment Update","id":"673bac7d759e0900011962ba","nic_number":"","notes":"","outcome":"Adicet Bio, Inc announced the opening of enrollment for the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42048133/adicet-opens-enrollment-for-adi-270-phase-1-clinical-trial-in-metastaticadvanced-clear-cell-renal-","source_type":"Press Release","status":"Phase 2","target_date":"","time":"16:07:09","updated":1731964924},{"commentary":"","companies":[{"cik":"906709","id":"603cef79b9e30d000188c07e","name":"Nektar Therapeutics","securities":[{"exchange":"NASDAQ","symbol":"NKTR"}]}],"created":1731936796,"date":"2024-11-18","drug":{"generic":false,"id":"673bae2c759e090001196351","indication_symptom":["For autoimmune Disorders"],"name":"NKTR-422"},"event_type":"Oral presentation","id":"673b421ccb444a0001726716","nic_number":"","notes":"","outcome":"Nektar Therapeutics announced its oral presentation highlighting preclinical data on NKTR-422 at the 2024 American College of Rheumatology (ACR) conference, being held in Washington, D.C. from November 14-19, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42047724/nektar-therapeutics-presents-first-preclinical-data-from-novel-csf-1-program-nktr-422-at-2024-amer","source_type":"Press Release","status":"","target_date":"","time":"08:33:16","updated":1731964865},{"commentary":"","companies":[{"cik":"","id":"664c5fb857d42200014c051e","name":"NewAmsterdam Pharma Company N.V","securities":[{"exchange":"NASDAQ","symbol":"NAMS"}]}],"created":1731936796,"date":"2024-11-18","drug":{"generic":false,"id":"6668416e20b09d000139da1a","indication_symptom":["CETP inhibitor"],"name":"Obicetrapib"},"event_type":"Results","id":"673b421ccb444a0001726717","nic_number":"","notes":"","outcome":"NewAmsterdam Pharma Company N.V announced additional results from the Company's Phase 3 BROOKLYN clinical trial (NCT05425745) evaluating obicetrapib in adult patients with heterozygous familial hypercholesterolemia (\"HeFH\"), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42047575/newamsterdam-pharma-presents-additional-data-from-pivotal-phase-3-brooklyn-clinical-trial-evaluati","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:33:16","updated":1731964686},{"commentary":"","companies":[{"cik":"1479615","id":"603cef7ab9e30d000188d13f","name":"Silence Therapeutics PLC","securities":[{"exchange":"NASDAQ","symbol":"SLN"},{"exchange":"OTC","symbol":"SLNCF"}]}],"created":1731936795,"date":"2024-11-18","drug":{"generic":false,"id":"673bae2c759e090001196353","indication_symptom":[" In atherosclerotic cardiovascular disease (ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125 nmol/L)."],"name":"zerlasiran"},"event_type":"Data","id":"673b421bcb444a000172670f","nic_number":"","notes":"","outcome":"Silence Therapeutics today presented end-of-treatment data from its Phase 2 ALPACAR-360 study of zerlasiran, a short interfering RNA (siRNA), in atherosclerotic cardiovascular disease (ASCVD) patients with high lipoprotein(a) [Lp(a)] levels (≥125 nmol/L).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42046710/silence-therapeutics-presents-late-breaking-phase-2-zerlasiran-data-at-2024-american-heart-associa","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:33:15","updated":1731964581},{"commentary":"","companies":[{"cik":"","id":"603cef7eb9e30d000188fe3f","name":"Cardiol Therapeutics Inc","securities":[]}],"created":1731936795,"date":"2024-11-18","drug":{"generic":false,"id":"61253175a3c6b90001eb07c8","indication_symptom":["Acute Myocarditis"],"name":"CardiolRx"},"event_type":"Results","id":"673b421bcb444a0001726711","nic_number":"","notes":"","outcome":"Cardiol Therapeutics Inc. reported clinical results from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/42042132/cardiol-therapeutics-phase-ii-maveric-pilot-clinical-results-in-recurrent-pericarditis-presented-at","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:33:15","updated":1731964304},{"commentary":"","companies":[{"cik":"1281895","id":"603cef7db9e30d000188f5fe","name":"Rocket Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"RCKT"}]}],"created":1731936796,"date":"2024-11-18","drug":{"generic":false,"id":"611a588fb6abe40001ee361b","indication_symptom":["Danon Disease"],"name":"RP-A501"},"event_type":"presented results","id":"673b421ccb444a0001726713","nic_number":"","notes":"","outcome":"Rocket Pharmaceuticals, Inc presented long-term safety and efficacy results from the Phase 1 RP-A501 study which showed that RP-A501 was generally well tolerated and all evaluable Danon disease patients demonstrated LAMP2 protein expression at 12 months (sustained up to 60 months) and reduction of left ventricular (LV) mass index by ≥10% at 12 months (sustained up to 54 months) after treatment.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42041162/rocket-pharmaceuticals-announces-new-england-journal-of-medicine-publication-of-phase-1-rp-a501-lo","source_type":"Press Release","status":"Phase 1","target_date":"","time":"08:33:16","updated":1731964192},{"commentary":"","companies":[{"cik":"1434868","id":"603cef7ab9e30d000188d47c","name":"Esperion Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"ESPR"}]}],"created":1731937801,"date":"2024-11-18","drug":{"generic":false,"id":"605271258b500900017a10f1","indication_symptom":["Hypercholesterolemia"],"name":"NEXLETOL (Bempedoic Acid) + Ezetimibe + Atorvastatin"},"event_type":"Presentation","id":"673b4609759e09000119275c","nic_number":"","notes":"","outcome":"Esperion announced the presentation of an analysis from the CLEAR Outcomes study focused on patients with Peripheral Artery Disease (PAD) who were unable or unwilling to take statin medications.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42040302/esperion-highlights-new-exploratory-data-from-clear-outcomes-trial-highlighting-value-of-nexletol-","source_type":"Press Release","status":"","target_date":"","time":"08:50:01","updated":1731964084},{"commentary":"","companies":[{"cik":"1514183","id":"603cef7db9e30d000188ef8d","name":"SILO Pharma Inc","securities":[{"exchange":"OTC","symbol":"SILO"}]}],"created":1731936796,"date":"2024-11-18","drug":{"generic":false,"id":"659851cf8fadc3000117d386","indication_symptom":["Treatment for PTSD"],"name":"SPC-15"},"event_type":"Results","id":"673b421ccb444a0001726719","nic_number":"","notes":"","outcome":"Silo Pharma, Inc announced promising results from a preclinical study on SPC-15. This new formulation, which targets both the serotonin 5-HT4 receptor (5-HT4R) and the NMDA receptor (NMDAR), has shown potential as a treatment for major depressive disorder (MDD), and other severe stress-related conditions..","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42035782/silo-pharma-announces-positive-results-for-novel-spc-15-treatment-targeting-stress-related-disorde","source_type":"Press Release","status":"","target_date":"","time":"08:33:16","updated":1731937757},{"commentary":"","companies":[{"cik":"1737287","id":"603cef7eb9e30d000188fda5","name":"Allogene Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"ALLO"}]}],"created":1731936797,"date":"2024-11-18","drug":{"generic":false,"id":"66f40768c2ed5b00011cd323","indication_symptom":["For the Treatment of Autoimmune Diseases"],"name":"ALLO-329"},"event_type":"Preclinical Data","id":"673b421dcb444a000172671c","nic_number":"","notes":"","outcome":"Allogene Therapeutics, Inc announced preclinical data for ALLO-329, an investigational allogeneic CD19/CD70 dual CAR T cell therapy being evaluated as a treatment for autoimmune diseases.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42035423/allogene-therapeutics-presents-preclinical-data-for-allo-329-an-allogeneic-cd19cd70-dual-car-t-for","source_type":"Press Release","status":"","target_date":"","time":"08:33:17","updated":1731937387},{"commentary":"","companies":[{"cik":"1444380","id":"603cef7db9e30d000188f5d6","name":"Nevro Corp","securities":[{"exchange":"NYSE","symbol":"NVRO"}]}],"created":1731936797,"date":"2024-11-18","drug":{"generic":false,"id":"67366d4091a4760001b3afc5","indication_symptom":[" In Comparison to Posterolateral and Lateral Approaches"],"name":"Nevro1™ SI Joint Fusion System"},"event_type":"Publication","id":"673b421dcb444a000172671d","nic_number":"","notes":"","outcome":"- Nevro Corp. announced the publication of new data in Medical Devices: Evidence and Research, which demonstrate the superiority of the Nevro1™ SI Joint Fusion System (\"Nevro1\"), a posterior integrated transfixation cage system offering enhanced stability, minimized bone removal and increased fusion potential compared to a posterolateral cylindrical threaded single-implant system.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42035435/new-study-demonstrates-multiple-advantages-of-nevro1-the-novel-si-joint-fusion-system-by-nevro-in-","source_type":"Press Release","status":"","target_date":"","time":"08:33:17","updated":1731937332},{"commentary":"","companies":[{"cik":"1434316","id":"603cef7db9e30d000188f315","name":"Fate Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"FATE"}]}],"created":1731936797,"date":"2024-11-18","drug":{"generic":false,"id":"61086e80a3c6b90001e869e0","indication_symptom":["Advanced B-cell Leukemias and Lymphomas"],"name":"FT819"},"event_type":"Data Presentation","id":"673b421dcb444a000172671f","nic_number":"","notes":"","outcome":"Fate Therapeutics,today presented initial clinical and translational data from the first patient treated in its FT819 Phase 1 Autoimmunity study for moderate-to-severe systemic lupus erythematosus (SLE) at the American College of Rheumatology (ACR) Convergence being held in Washington, D.C.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42034629/fate-therapeutics-presents-6-month-follow-up-data-on-first-patient-treated-in-phase-1-autoimmunity","source_type":"Press Release","status":"Phase 1","target_date":"","time":"08:33:17","updated":1731937068},{"commentary":"","companies":[{"cik":"","id":"673b424a6295c70001b9b973","name":"Contineum Therapeutis Inc","securities":[{"exchange":"NASDAQ","symbol":"CNTM"}]}],"created":1731936797,"date":"2024-11-18","drug":{"generic":false,"id":"67366d4191a4760001b3afc7","indication_symptom":["For Chronic Pain"],"name":"PIPE-791"},"event_type":"FDA Authorization","id":"673b421dcb444a0001726721","nic_number":"","notes":"","outcome":"Contineum Therapeutics, Inc. announced authorization of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for PIPE-791 for the treatment of chronic pain associated with two separate indications, osteoarthritis (OA) and low back pain (LBP). PIPE-791 is a novel, brain penetrant, small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1R).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42034633/contineum-therapeutics-expands-clinical-development-of-pipe-791-with-fda-authorization-of-its-inve","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"","time":"08:33:17","updated":1731936986},{"commentary":"","companies":[{"cik":"","id":"622bb36bcc9cd90001f93c21","name":"Biomea Fusion, Inc.","securities":[{"exchange":"NASDAQ","symbol":"BMEA"}]}],"created":1731935821,"date":"2024-11-18","drug":{"generic":false,"id":"650c1e668345120001a3d11f","indication_symptom":[" To treat and improve the lives of patients with genetically defined cancers and metabolic diseases"," "],"name":"COVALENT-111"},"event_type":"Presentation","id":"673b3e4dcb444a000172664d","nic_number":"","notes":"","outcome":"Biomea Fusion, Inc. announced its presentations at the 1st Annual Asian Conference on Innovative Therapies for Diabetes Management (ATTD-ASIA 2024) taking place in Singapore, 18-20 November 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42034252/late-breaker-oral-presentation-showing-new-analysis-from-the-escalation-portion-of-covalent-111-pr","source_type":"Press Release","status":"","target_date":"","time":"08:17:01","updated":1731936758},{"commentary":"","companies":[{"cik":"","id":"66f5419a6d02590001cb3974","name":"MBX Biosciences Inc","securities":[{"exchange":"NASDAQ","symbol":"MBX"}]}],"created":1731935821,"date":"2024-11-18","drug":{"generic":false,"id":"67366d4191a4760001b3afc9","indication_symptom":["For the Treatment of Post-Bariatric Hypoglycemia"],"name":"MBX 1416"},"event_type":"Provided Update","id":"673b3e4dcb444a000172664f","nic_number":"","notes":"","outcome":"MBX Biosciences, Inc. announced the completion of the last subject's last visit in its Phase 1 single and multiple ascending dose trial of MBX 1416, the Company's long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist in development for the treatment of post-bariatric hypoglycemia (PBH).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42034253/mbx-biosciences-announces-last-subject-last-visit-in-phase-1-trial-of-mbx-1416-for-the-treatment-o","source_type":"Press Release","status":"Phase 1","target_date":"","time":"08:17:01","updated":1731936694},{"commentary":"","companies":[{"cik":"","id":"603cef7db9e30d000188f36c","name":"Allarity Therapeutics AS","securities":[{"exchange":"NASDAQ","symbol":"ALLR"}]}],"created":1731935821,"date":"2024-11-18","drug":{"generic":false,"id":"656f21fc258cdd000172e5c1","indication_symptom":[" For ovarian cancer (AOC)"],"name":"Stenoparib"},"event_type":"Provided Update","id":"673b3e4dcb444a0001726651","nic_number":"","notes":"","outcome":"Allarity Therapeutics, Inc today provided a corporate update highlighting three significant developments: extended treatment duration for patients in its ongoing Phase 2 stenoparib trial, a strengthened cash position supporting initiation of a follow-up FDA registrational trial, and new revenue-generating activities from Allarity's laboratory services.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42034264/allarity-therapeutics-reports-key-progress-in-phase-2-stenoparib-trial-and-strategic-corporate-adv","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:17:01","updated":1731936577},{"commentary":"","companies":[{"cik":"1434316","id":"603cef7db9e30d000188f315","name":"Fate Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"FATE"}]}],"created":1731935821,"date":"2024-11-18","drug":{"generic":false,"id":"67366d4191a4760001b3afcb","indication_symptom":[" In relapsed / refractory B-cell lymphoma"],"name":"FT522"},"event_type":"Data Presentation","id":"673b3e4dcb444a0001726653","nic_number":"","notes":"","outcome":"Fate Therapeutics, Inc. today presented initial clinical and translational data from the Company's Phase 1 study of FT522 in relapsed / refractory B-cell lymphoma at the American College of Rheumatology (ACR) Convergence being held in Washington, D.C.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42034629/fate-therapeutics-presents-6-month-follow-up-data-on-first-patient-treated-in-phase-1-autoimmunity","source_type":"Press Release","status":"Phase 1","target_date":"","time":"08:17:01","updated":1731936509},{"commentary":"","companies":[{"cik":"1133416","id":"603cef78b9e30d000188ba46","name":"Galectin Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"GALT"}]}],"created":1731936191,"date":"2024-11-18","drug":{"generic":false,"id":"6064892dfdf9b900013abe48","indication_symptom":["Non-alcoholic steatohepatitis (NASH) with cirrhosis"],"name":"Belapectin (Formerly GR-MD-02)"},"event_type":"Poster Presentation","id":"673b3fbfcb444a000172669d","nic_number":"","notes":"","outcome":"- Galectin Therapeutics, Inc. nnounced the presentation of three posters on the ongoing NAVIGATE trial in patients with MASH cirrhosis and portal hypertension at the American Association for the Study of Liver Diseases (AASLD)'s annual meeting 2024 Liver Meeting, being held November 15-19, 2024 in San Diego, California.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42034320/galectin-therapeutics-presents-three-abstracts-at-the-american-association-for-the-study-of-liver-","source_type":"Press Release","status":"","target_date":"","time":"08:23:11","updated":1731936375},{"commentary":"","companies":[{"cik":"1535955","id":"603cef7db9e30d000188f0da","name":"Lipocine Inc","securities":[{"exchange":"NASDAQ","symbol":"LPCN"}]}],"created":1731935822,"date":"2024-11-18","drug":{"generic":false,"id":"61c328c23519e40001259f3a","indication_symptom":["Liver cirrhosis"],"name":"LPCN 1148"},"event_type":"Publication","id":"673b3e4ecb444a0001726655","nic_number":"","notes":"","outcome":"Lipocine Inc announced the publication and discussion of a manuscript \"Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial\" in the journal Hepatology and discussion at The Liver Meeting (AASLD) 2024 Editor's Cut: Clinical Study Session held on November 16, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42034296/lipocine-announces-publication-and-discussion-of-lpcn-1148-manuscript-at-the-liver-meeting-2024-ed","source_type":"Press Release","status":"","target_date":"","time":"08:17:02","updated":1731936256},{"commentary":"","companies":[{"cik":"1095435","id":"603cef78b9e30d000188b684","name":"Portage Biotech Inc","securities":[{"exchange":"CNQ","symbol":"PBT.U"},{"exchange":"NASDAQ","symbol":"PRTG"}]}],"created":1731935822,"date":"2024-11-18","drug":{"generic":false,"id":"60b77f8de1e2bd0001d1341f","indication_symptom":["Solid Tumors"],"name":"INT230-6 (PORT-1)"},"event_type":"Provided Update","id":"673b3e4ecb444a0001726659","nic_number":"","notes":"","outcome":"Intensity Therapeutics, Inc. announced that Christian F. Meyer M.D., Ph.D., Assistant Professor of Oncology and lead medical oncologist for adult sarcoma patients at Johns Hopkins University's Sidney Kimmel Cancer Center, presented final safety and efficacy data from the Company's Phase 1/2 clinical trial of INT230-6 that was used as a monotherapy in patients with relapsed, refractory, and metastatic sarcomas, along with an overview of the Company's ongoing INVINCIBLE-3 Study design (NCT06263231).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42034313/intensity-therapeutics-presents-int230-6-phase-12-data-in-sarcoma-and-an-overview-of-its-ongoing-g","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"08:17:02","updated":1731936086},{"commentary":"","companies":[{"cik":"","id":"655206cab3615100015df128","name":"Sagimet Biosciences Inc","securities":[]}],"created":1731935822,"date":"2024-11-18","drug":{"generic":false,"id":"65520a5f207b9d0001912b8d","indication_symptom":["For Liver 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Inc","securities":[{"exchange":"TSE","symbol":"BHC"},{"exchange":"NYSE","symbol":"BHC"}]}],"created":1731935816,"date":"2024-11-18","drug":{"generic":false,"id":"64c0cdc09c212e0001522268","indication_symptom":["For the Treatment of Acne Vulgaris"],"name":"CABTREO"},"event_type":"Recommendation","id":"673b3e48cb444a000172664a","nic_number":"","notes":"","outcome":"Bausch Health, Canada Inc., announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, a new triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older,1 has received positive reimbursement recommendations from Canada's Drug Agency (CDA, formerly the Canadian Agency for Drugs and Technology in Health) and Quebec's Institut national d'excellence en santé et en services sociaux (INESSS).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac42034476/bausch-health-and-salix-to-present-at-the-american-association-for-the-study-of-liver-disease-aas","source_type":"Press Release","status":"","target_date":"","time":"08:16:56","updated":1731935929},{"commentary":"","companies":[{"cik":"879407","id":"603cef78b9e30d000188bd6a","name":"Arrowhead Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ARWR"}]}],"created":1731935676,"date":"2024-11-18","drug":{"generic":false,"id":"665dbf633b1273000139d3ad","indication_symptom":["In Patients with Familial Chylomicronemia Syndrome"],"name":"plozasiran"},"event_type":"NDA Filing","id":"673b3dbccb444a000172661e","nic_number":"","notes":"","outcome":"Arrowhead Pharmaceuticals, Inc announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), a severe and rare genetic disease which currently has no FDA approved treatments.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42033594/arrowhead-pharmaceuticals-submits-new-drug-application-to-u-s-fda-for-plozasiran-for-the-treatment","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"","time":"08:14:36","updated":1731935813},{"commentary":"","companies":[{"cik":"879407","id":"603cef78b9e30d000188bd6a","name":"Arrowhead Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ARWR"}]}],"created":1731935717,"date":"2024-11-18","drug":{"generic":false,"id":"665dbf633b1273000139d3ad","indication_symptom":["In Patients with Familial Chylomicronemia Syndrome"],"name":"plozasiran"},"event_type":"Regulatory Update","id":"673b3de5cb444a000172662a","nic_number":"","notes":"","outcome":"Arrowhead also intends to submit applications for approval of investigational plozasiran for the treatment of patients with FCS to additional regulatory authorities in 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42033594/arrowhead-pharmaceuticals-submits-new-drug-application-to-u-s-fda-for-plozasiran-for-the-treatment","source_type":"Press Release","status":"","target_date":"","time":"08:15:17","updated":1731935750},{"commentary":"","companies":[{"cik":"879407","id":"603cef78b9e30d000188bd6a","name":"Arrowhead Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ARWR"}]}],"created":1731935575,"date":"2024-11-18","drug":{"generic":false,"id":"665dbf633b1273000139d3ad","indication_symptom":["In Patients with Familial Chylomicronemia Syndrome"],"name":"plozasiran"},"event_type":"Results","id":"673b3d57cb444a000172660b","nic_number":"","notes":"","outcome":"Arrowhead Pharmaceuticals, Inc announced new results from the Phase 3 PALISADE study and the open-label extension from the Phase 2 MUIR and SHASTA-2 studies of investigational plozasiran.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42033576/arrowhead-pharmaceuticals-presents-new-data-at-aha24-from-palisade-phase-3-study-and-open-label-ex","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:12:55","updated":1731935665},{"commentary":"","companies":[{"cik":"1590877","id":"603cef7eb9e30d000188f7a1","name":"Regenxbio Inc","securities":[{"exchange":"NASDAQ","symbol":"RGNX"}]}],"created":1731935462,"date":"2024-11-18","drug":{"generic":false,"id":"619bc45d3b46f20001438716","indication_symptom":["Duchenne Muscular Dystrophy"],"name":"RGX-202"},"event_type":"Efficacy and Safety Data","id":"673b3ce6cb444a00017265f2","nic_number":"","notes":"","outcome":"REGENXBIO announced new, positive efficacy and safety data from the Phase I/II portion of the study, including the first functional data.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42033036/regenxbio-initiates-pivotal-phase-of-affinity-duchenne-trial-of-rgx-202-gene-therapy-and-reports-p","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"08:11:02","updated":1731935516},{"commentary":"","companies":[{"cik":"1590877","id":"603cef7eb9e30d000188f7a1","name":"Regenxbio Inc","securities":[{"exchange":"NASDAQ","symbol":"RGNX"}]}],"created":1731935420,"date":"2024-11-18","drug":{"generic":false,"id":"619bc45d3b46f20001438716","indication_symptom":["Duchenne Muscular Dystrophy"],"name":"RGX-202"},"event_type":"Provided Update","id":"673b3cbccb444a00017265e8","nic_number":"","notes":"","outcome":"REGENXBIO announced that AFFINITY DUCHENNE®, the multi-center, open-label trial of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy (Duchenne), has advanced to pivotal stage and dosed its first patient.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42033036/regenxbio-initiates-pivotal-phase-of-affinity-duchenne-trial-of-rgx-202-gene-therapy-and-reports-p","source_type":"Press Release","status":"","target_date":"","time":"08:10:20","updated":1731935515},{"commentary":"","companies":[{"cik":"1720580","id":"603cef7fb9e30d000189010e","name":"Adicet Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"ACET"}]}],"created":1731935357,"date":"2024-11-18","drug":{"generic":false,"id":"6048da983c2ff90001a1268b","indication_symptom":["B cell non-Hodgkin's lymphoma (NHL)"],"name":"ADI-001"},"event_type":"Dose Update","id":"673b3c7dcb444a00017265d5","nic_number":"","notes":"","outcome":"Adicet Bio, Inc announced that the first LN patient has been dosed in the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42032774/adicet-bio-announces-first-lupus-nephritis-patient-dosed-in-phase-1-clinical-trial-of-adi-001-in-a","source_type":"Press Release","status":"Phase 1","target_date":"","time":"08:09:17","updated":1731935404},{"commentary":"","companies":[{"cik":"1759138","id":"603cef7eb9e30d000188ffed","name":"Cabaletta Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"CABA"}]}],"created":1731935186,"date":"2024-11-18","drug":{"generic":false,"id":"6548de99caf68a0001072ba8","indication_symptom":["For Treatment of Generalized Myasthenia Gravis"],"name":"CABA-201"},"event_type":"New Data","id":"673b3bd2cb444a00017265bd","nic_number":"","notes":"","outcome":"Cabaletta Bio, Inc. announced new and updated clinical data on CABA-201 demonstrating the potential to achieve drug-free, compelling clinical responses based on eight patients dosed across the ongoing Phase 1/2 RESET-Myositis™, RESET-SLE™ and RESET-SSc™ clinical trials.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42032745/cabaletta-bio-presents-positive-clinical-safety-and-efficacy-data-on-caba-201-at-acr-convergence-2","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"08:06:26","updated":1731935343},{"commentary":"","companies":[{"cik":"1430306","id":"603cef7cb9e30d000188e1dc","name":"Tonix Pharmaceuticals Holding Corp","securities":[{"exchange":"NASDAQ","symbol":"TNXP"}]}],"created":1731935104,"date":"2024-11-18","drug":{"generic":false,"id":"60ae2f85c878010001d58cf5","indication_symptom":["Fibromyalgia"],"name":"TNX-102 SL"},"event_type":"Poster Presentation","id":"673b3b80cb444a00017265aa","nic_number":"","notes":"","outcome":"Tonix Pharmaceuticals presented data in a poster presentation at the ACR Convergence 2024 Annual Meeting, held November 14-19, 2024, in Washington, D.C. A copy of the Company's presentation, titled \"Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia\"","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42032769/tonix-pharmaceuticals-presented-data-and-analyses-of-tnx-102-sl-treatment-effects-on-fibromyalgia-","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:05:04","updated":1731935167},{"commentary":"","companies":[{"cik":"1341235","id":"603cef7db9e30d000188f400","name":"Aldeyra Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"ALDX"}]}],"created":1731935021,"date":"2024-11-18","drug":{"generic":false,"id":"63e112cd3b88450001bd7f3c","indication_symptom":["Small-molecule modulator of RASP"],"name":"Reproxalap"},"event_type":"PDUFA Date","id":"673b3b2dcb444a000172658e","nic_number":"","notes":"","outcome":"Aldeyra Therapeutics Announces that PDUFA Date is April 2, 2025","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42032771/aldeyra-therapeutics-announces-fda-acceptance-for-review-of-reproxalap-new-drug-application-for-th","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"2025-04-02","time":"08:03:41","updated":1731935093},{"commentary":"","companies":[{"cik":"1341235","id":"603cef7db9e30d000188f400","name":"Aldeyra Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"ALDX"}]}],"created":1731934964,"date":"2024-11-18","drug":{"generic":false,"id":"63e112cd3b88450001bd7f3c","indication_symptom":["Small-molecule modulator of RASP"],"name":"Reproxalap"},"event_type":"FDA Accepted","id":"673b3af4cb444a0001726581","nic_number":"","notes":"","outcome":"Aldeyra Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42032771/aldeyra-therapeutics-announces-fda-acceptance-for-review-of-reproxalap-new-drug-application-for-th","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"","time":"08:02:44","updated":1731935093},{"commentary":"","companies":[{"cik":"1649904","id":"603cef7db9e30d000188f58a","name":"Rhythm Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"RYTM"}]}],"created":1731934897,"date":"2024-11-18","drug":{"generic":false,"id":"62cd6bc7e40229000131b5fb","indication_symptom":["Hypothalamic Obesity"],"name":"Setmelanotide (HO)"},"event_type":"Presentation","id":"673b3ab1cb444a0001726570","nic_number":"","notes":"","outcome":"Rhythm Pharmaceuticals, Inc. announced the presentation of new, real-world data that showed four pediatric patients with acquired hypothalamic obesity or congenital hypothalamic obesity achieved \u003e5% weight reduction at three months on setmelanotide, a melanocortin-4 receptor (MC4R) agonist.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42032748/rhythm-pharmaceuticals-announces-five-presentations-at-espe-2024-including-new-real-world-data-in-","source_type":"Press Release","status":"","target_date":"","time":"08:01:37","updated":1731934949},{"commentary":"","companies":[{"cik":"","id":"603cef7fb9e30d0001890315","name":"Cybin Inc","securities":[]}],"created":1731934799,"date":"2024-11-18","drug":{"generic":false,"id":"64b990bb9c212e0001517a20","indication_symptom":["Major Depressive Disorder"],"name":"CYB003"},"event_type":"Efficacy Data","id":"673b3a4fcb444a000172655d","nic_number":"","notes":"","outcome":"Cybin Inc. announced unprecedented 12-month efficacy data from its Phase 2 study of CYB003, a proprietary deuterated psilocin program in development for the potential adjunctive treatment of major depressive disorder (\"MDD\").","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42032791/cybin-reports-positive-phase-2-data-for-cyb003-demonstrating-breakthrough-12-month-efficacy-in-tre","source_type":"Press Release","status":"Phase 2","target_date":"","time":"07:59:59","updated":1731934858},{"commentary":"","companies":[{"cik":"","id":"6153bd1e73a5f300019b65fa","name":"Acurx Pharmaceuticals, Inc.","securities":[{"exchange":"NASDAQ","symbol":"ACXP"}]}],"created":1731934718,"date":"2024-11-18","drug":{"generic":false,"id":"6153bce9fff0b50001d99a03","indication_symptom":["Clostridioides difficile Infection"],"name":"Ibezapolstat"},"event_type":"Provided Update","id":"673b39fecb444a000172654d","nic_number":"","notes":"","outcome":"Acurx Pharmaceuticals, Inc. announced its support and participation in the Inaugural Peggy Lillis Foundation (virtual) Scientific Symposium, held on Friday, November 15, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42032801/acurx-sponsored-and-participated-in-the-peggy-lillis-foundation-inaugural-cdi-scientific-symposium","source_type":"Press Release","status":"","target_date":"","time":"07:58:38","updated":1731934785},{"commentary":"","companies":[{"cik":"1503802","id":"603cef7db9e30d000188f33d","name":"Karyopharm Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"KPTI"}]}],"created":1731934653,"date":"2024-11-18","drug":{"generic":false,"id":"618437c980db050001bc7968","indication_symptom":["Myelofibrosis"],"name":"Selinexor"},"event_type":"Data Presentation","id":"673b39bdcb444a000172653d","nic_number":"","notes":"","outcome":"Karyopharm Therapeutics Inc. nnounced abstracts detailing selinexor data have been selected to be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7-10, 2024 in San Diego, CA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42032809/karyopharm-to-present-selinexor-data-at-the-66th-american-society-of-hematology-annual-meeting-and","source_type":"Press Release","status":"","target_date":"","time":"07:57:33","updated":1731934703},{"commentary":"","companies":[{"cik":"","id":"6617e89540e824000148ad4e","name":"Neurogene Inc","securities":[]}],"created":1731934574,"date":"2024-11-18","drug":{"generic":false,"id":"661d1fac68f1bf000100d4cf","indication_symptom":["For Rett Syndrome"],"name":"NGN-401"},"event_type":"Provided Update","id":"673b396ecb444a000172652b","nic_number":"","notes":"","outcome":"Neurogene Inc announced an update on its ongoing Phase 1/2 open-label clinical trial evaluating NGN-401 gene therapy for the treatment of Rett syndrome.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42032551/neurogene-provides-update-on-ngn-401-gene-therapy-clinical-trial-for-rett-syndrome","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"07:56:14","updated":1731934629},{"commentary":"","companies":[{"cik":"1743881","id":"603cef7eb9e30d000188ff2c","name":"BridgeBio Pharma Inc","securities":[{"exchange":"NASDAQ","symbol":"BBIO"}]}],"created":1731927555,"date":"2024-11-18","drug":{"generic":false,"id":"62e048b08032230001a2d8da","indication_symptom":["Achondroplasia (ACH)"],"name":"Infigratinib (PROPEL 2)"},"event_type":"Positive Results","id":"673b1e03759e090001191e0b","nic_number":"","notes":"","outcome":"BridgeBio Pharma, Inc. announced that positive 18-month results from PROPEL 2, a Phase 2 trial of the investigational therapy infigratinib in children with achondroplasia, were published as an original research article in the New England Journal of Medicine (NEJM) today","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42031221/bridgebio-pharma-announces-publication-in-the-new-england-journal-of-medicine-of-phase-2-propel-2-","source_type":"Press Release","status":"Phase 2","target_date":"","time":"05:59:15","updated":1731927627},{"commentary":"","companies":[{"cik":"882796","id":"603cef78b9e30d000188b665","name":"BioCryst Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"BCRX"}]}],"created":1731917263,"date":"2024-11-18","drug":{"generic":false,"id":"603e3ae4b3e2040001494e19","indication_symptom":["Hereditary angioedema (HAE)"],"name":"ORLADEYO (berotralstat)"},"event_type":"Recommendation","id":"673af5cfcb444a0001725df5","nic_number":"","notes":"","outcome":"BioCryst Pharmaceuticals, Inc announced that the Health Services Executive (HSE) in Ireland has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42029345/biocryst-launches-orladeyo-berotralstat-in-ireland","source_type":"Press Release","status":"","target_date":"","time":"03:07:43","updated":1731917324},{"commentary":"","companies":[{"cik":"1551152","id":"603cef7db9e30d000188f1b8","name":"AbbVie Inc","securities":[{"exchange":"NYSE","symbol":"ABBV"}]}],"created":1731916244,"date":"2024-11-18","drug":{"generic":false,"id":"66f12e76c2ed5b00011c6c6a","indication_symptom":["For the Treatment of Certain Adult Ovarian Cancer"],"name":"ELAHERE"},"event_type":"Marketing authorization","id":"673af1d4cb444a0001725d1b","nic_number":"","notes":"","outcome":"AbbVie announced the European Commission (EC) granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. ELAHERE is the first and only folate receptor alpha (FRɑ)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42029072/abbvie-receives-european-commission-approval-of-elahere-mirvetuximab-soravtansine-for-the-treatmen","source_type":"Press Release","status":"","target_date":"","time":"02:50:44","updated":1731916304},{"commentary":"","companies":[{"cik":"1178670","id":"603cef78b9e30d000188bc09","name":"Alnylam Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ALNY"}]}],"created":1731916710,"date":"2024-11-17","drug":{"generic":false,"id":"67366d4191a4760001b3afcd","indication_symptom":[" For the treatment of transthyretin (ATTR) amyloidosis"],"name":"nucresiran"},"event_type":"Provided Update","id":"673af3a6cb444a0001725d83","nic_number":"","notes":"","outcome":"Alnylam Pharmaceuticals, Inc announced that it Alnylam Continues to Expect to Share Phase 3 Development Plans in Q1 2025 –","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42026489/alnylam-announces-interim-phase-1-data-of-nucresiran-aln-ttrsc04-showing-rapid-knockdown-of-ttr-th","source_type":"Press Release","status":"","target_date":"2025-Q1","time":"02:58:30","updated":1731916794},{"commentary":"","companies":[{"cik":"1178670","id":"603cef78b9e30d000188bc09","name":"Alnylam Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ALNY"}]}],"created":1731916619,"date":"2024-11-17","drug":{"generic":false,"id":"67366d4191a4760001b3afcd","indication_symptom":[" For the treatment of transthyretin (ATTR) amyloidosis"],"name":"nucresiran"},"event_type":"Results","id":"673af34bcb444a0001725d62","nic_number":"","notes":"","outcome":"Alnylam Pharmaceuticals, Inc. announced the presentation of new results from its Phase 1 study of nucresiran (formerly ALN-TTRsc04), a next-generation RNAi therapeutic in development for the treatment of transthyretin (ATTR) amyloidosis.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42026489/alnylam-announces-interim-phase-1-data-of-nucresiran-aln-ttrsc04-showing-rapid-knockdown-of-ttr-th","source_type":"Press Release","status":"Phase 1","target_date":"","time":"02:56:59","updated":1731916794},{"commentary":"","companies":[{"cik":"1549595","id":"603cef7fb9e30d0001890186","name":"Nurix Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"NRIX"}]}],"created":1731916547,"date":"2024-11-17","drug":{"generic":false,"id":"60a7b3de35dfe50001b94afa","indication_symptom":["Autoimmune Disease"],"name":"NX-5948"},"event_type":"Presentation","id":"673af303cb444a0001725d41","nic_number":"","notes":"","outcome":"Nurix Therapeutics, Inc. announced the presentation of preclinical data, including mechanism of action and relevant disease models, from two pipeline programs: NX-5948 and GS-6791.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42026724/nurix-therapeutics-presents-preclinical-data-from-two-autoimmune-and-inflammatory-disease-programs","source_type":"Press Release","status":"","target_date":"","time":"02:55:47","updated":1731916606},{"commentary":"","companies":[{"cik":"1061983","id":"603cef78b9e30d000188be71","name":"Cytokinetics Inc","securities":[{"exchange":"NASDAQ","symbol":"CYTK"}]}],"created":1731917115,"date":"2024-11-16","drug":{"generic":false,"id":"61b27c05c08e470001f016c4","indication_symptom":["Symptomatic obstructive hypertrophic cardiomyopathy (oHCM)"],"name":"Aficamten"},"event_type":"New Data","id":"673af53bcb444a0001725de4","nic_number":"","notes":"","outcome":"Cytokinetics, Incorporated announced new data relating to aficamten and hypertrophic cardiomyopathy (HCM), were presented at the American Heart Association Scientific Sessions 2024 in Chicago, IL.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42023836/cytokinetics-presents-additional-data-from-galactic-hf-at-the-american-heart-association-scientifi","source_type":"Press Release","status":"","target_date":"","time":"03:05:15","updated":1731917157},{"commentary":"","companies":[{"cik":"1720580","id":"603cef7fb9e30d000189010e","name":"Adicet Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"ACET"}]}],"created":1731917040,"date":"2024-11-16","drug":{"generic":false,"id":"6048da983c2ff90001a1268b","indication_symptom":["B cell non-Hodgkin's lymphoma (NHL)"],"name":"ADI-001"},"event_type":"Clinical Data","id":"673af4f0cb444a0001725dd0","nic_number":"","notes":"","outcome":"Adicet Bio, Inc announced that clinical biomarker data from the ADI-001 Phase 1 GLEAN trial which demonstrates robust tissue homing, significant CAR T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue will be featured in an oral session at ACR Convergence 2024 in Washington, D.C., November 14-19.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42023835/adicet-bio-presents-clinical-biomarker-data-for-off-the-shelf-car-t-cell-therapy-in-an-oral-sessio","source_type":"Press Release","status":"","target_date":"","time":"03:04:00","updated":1731917092},{"commentary":"","companies":[{"cik":"1652130","id":"603cef7eb9e30d000188f8ae","name":"Intellia Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"NTLA"}]},{"cik":"872589","id":"603cef78b9e30d000188ba95","name":"Regeneron Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"REGN"}]}],"created":1731916977,"date":"2024-11-16","drug":{"generic":false,"id":"60d8eeef74f1490001e18e91","indication_symptom":["Transthyretin (ATTR) Amyloidosis"],"name":"NTLA-2001"},"event_type":"Positive Data","id":"673af4b1cb444a0001725db8","nic_number":"","notes":"","outcome":"Intellia Therapeutics, Inc announced positive new clinical data from the ongoing Phase 1 trial of nexiguran ziclumeran (nex-z, also known as NTLA-2001) in patients with transthyretin (ATTR) amyloidosis. Nex-z is an investigational in vivo CRISPR-based gene editing therapy in development as a one-time treatment for ATTR amyloidosis. .","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42024130/intellia-announces-first-clinical-evidence-from-ongoing-phase-1-study-that-nexiguran-ziclumeran-ne","source_type":"Press Release","status":"Phase 1","target_date":"","time":"03:02:57","updated":1731917023},{"commentary":"","companies":[{"cik":"885725","id":"603cef78b9e30d000188b68d","name":"Boston Scientific Corp","securities":[{"exchange":"NYSE","symbol":"BSX"},{"exchange":"NYSE","symbol":"BSXpA"}]}],"created":1731916865,"date":"2024-11-16","drug":{"generic":false,"id":"64f86124add8280001ff7b1f","indication_symptom":["Device"],"name":"WATCHMAN FLX™"},"event_type":"Results","id":"673af441cb444a0001725da2","nic_number":"","notes":"","outcome":"Boston Scientific Corporation announced positive three-year primary endpoint results from the OPTION global clinical trial of the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. Key findings from the study comparing the device to first-line oral anticoagulation (OAC) – including direct oral anticoagulants (DOAC) (95%) and warfarin (5%) – for stroke risk reduction in patients with non-valvular atrial fibrillation following a cardiac ablation were presented in a late-breaking science session at the American Heart Association's Scientific Sessions 2024, and simultaneously published in The New England Journal of Medicine.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42024655/boston-scientific-watchman-flx-left-atrial-appendage-closure-device-demonstrates-superior-bleeding","source_type":"Press Release","status":"","target_date":"","time":"03:01:05","updated":1731916956},{"commentary":"","companies":[{"cik":"1395937","id":"603cef7db9e30d000188f47d","name":"Syndax Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"SNDX"}]}],"created":1731710378,"date":"2024-11-15","drug":{"generic":false,"id":"6516c5db9705270001e211c8","indication_symptom":["Relapsed/Refractory KMT2Ar Acute Leukemia"],"name":"Revumenib"},"event_type":"FDA Approval","id":"6737cdaa6295c70001b9b467","nic_number":"","notes":"","outcome":"Syndax Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the first and only menin inhibitor for the treatment of relapsed or refractory (R/R) acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients one year and older.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n42020752/syndax-announces-fda-approval-of-revuforj-revumenib-the-first-and-only-menin-inhibitor-to-treat-ad","source_type":"Press Release","status":"FDA Approved","target_date":"","time":"17:39:38","updated":1731710443},{"commentary":"","companies":[{"cik":"1756594","id":"603cef7eb9e30d000188fa0c","name":"Inventiva SA","securities":[{"exchange":"NASDAQ","symbol":"IVA"},{"exchange":"OTC","symbol":"IVEVF"}]}],"created":1731708974,"date":"2024-11-15","drug":{"generic":false,"id":"60c13217f0c52b0001fce155","indication_symptom":["Nonalcoholic steatohepatitis (NASH)"],"name":"Lanifibranor"},"event_type":"Presentation","id":"6737c82e56a2320001305d81","nic_number":"","notes":"","outcome":"Inventiva announced the presentation of the final analysis of LEGEND, Phase 2 proof-of-concept clinical trial, evaluating lanifibranor in combination with empagliflozin in patients with MASH and Type 2 Diabetes (T2D).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42018483/inventiva-will-present-data-from-the-final-analysis-of-the-phase-2-study-evaluating-the-combinatio","source_type":"Press Release","status":"Phase 2","target_date":"","time":"17:16:14","updated":1731709060},{"commentary":"","companies":[{"cik":"","id":"65804e1dde13e400018dc310","name":"Scilex Holding Company","securities":[]}],"created":1731680934,"date":"2024-11-15","drug":{"generic":false,"id":"66cc246238103d00010e357f","indication_symptom":["For the treatment of acute and chronic pain"],"name":"GLOPERBA®"},"event_type":"Data Presentation","id":"67375aa6cb444a000172250c","nic_number":"","notes":"","outcome":"Scilex Holding Company announced presentation of data at the 2024 American College of Rheumatology Convergence conference to be held at the Walter E. Washington Convention Center in Washington, D.C. on November 14 – 19, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42008602/scilex-holding-company-announces-presentation-of-data-at-the-2024-american-college-of-rheumatology","source_type":"Press Release","status":"","target_date":"","time":"09:28:54","updated":1731680979},{"commentary":"","companies":[{"cik":"","id":"665ecdcc3b1273000139f7be","name":"CERo Therapeutics Holdings Inc","securities":[]}],"created":1731680833,"date":"2024-11-15","drug":{"generic":false,"id":"665ecd48f865560001879345","indication_symptom":["For Ovarian Cancer"],"name":"CER-1236"},"event_type":"FDA Clearance","id":"67375a41cb444a00017224fc","nic_number":"","notes":"","outcome":"CERo Therapeutics Holdings, Inc announces that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug Application (IND) for Phase 1 clinical trials of its lead compound, CER-1236, in acute myelogenous leukemia (AML).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42008190/cero-therapeutics-inc-receives-fda-clearance-of-investigational-new-drug-application-to-initiate-p","source_type":"Press Release","status":"Investigational New Drug (IND)","target_date":"","time":"09:27:13","updated":1731680895},{"commentary":"","companies":[{"cik":"14272","id":"603cef78b9e30d000188b6a3","name":"Bristol-Myers Squibb Company","securities":[{"exchange":"NYSE","symbol":"BMY"},{"exchange":"OTC","symbol":"BMYMP"}]}],"created":1731677130,"date":"2024-11-15","drug":{"generic":false,"id":"6082e3b3d46fa800015af622","indication_symptom":["Unresectable Malignant Pleural Mesothelioma"],"name":"Opdivo (Nivolumab) + Yervoy (Ipilimumab) CheckMate-743"},"event_type":"Recommended Approval","id":"67374bca759e09000118dc15","nic_number":"","notes":"","outcome":"Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) plus Yervoy® (ipilimumab)for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). Of significance, the CheckMate -8HW trial results showed reduction in the risk of disease progression or death by 79% (HR: 0.21; 95% CI: 0.14-0.32; p\u003c0.0001) compared to chemotherapy in this patient population.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42007470/bristol-myers-squibb-receives-positive-chmp-opinion-for-opdivo-nivolumab-plus-yervoy-ipilimumab-fo","source_type":"Press Release","status":"European Medicines Agency (EMA)","target_date":"","time":"08:25:30","updated":1731677253},{"commentary":"","companies":[{"cik":"1785173","id":"603cef7eb9e30d0001890001","name":"89bio Inc","securities":[{"exchange":"NASDAQ","symbol":"ETNB"}]}],"created":1731676988,"date":"2024-11-15","drug":{"generic":false,"id":"66040ef1cad84c00018292b5","indication_symptom":["In the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) "],"name":"Pegozafermin"},"event_type":"Analysis","id":"67374b3c759e09000118dbf2","nic_number":"","notes":"","outcome":"89bio, Inc. announced new analyses of data from the Phase 2b ENLIVEN trial evaluating pegozafermin in metabolic dysfunction-associated steatohepatitis (MASH) patients with advanced fibrosis. T","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42006999/89bio-presents-new-analyses-evaluating-pegozafermin-and-potential-benefit-of-non-invasive-tests-fr","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:23:08","updated":1731677059},{"commentary":"","companies":[{"cik":"1339970","id":"603cef7eb9e30d000188f6cb","name":"aTyr Pharma Inc","securities":[{"exchange":"NASDAQ","symbol":"LIFE"}]}],"created":1731676264,"date":"2024-11-15","drug":{"generic":false,"id":"67366d4191a4760001b3afcf","indication_symptom":[" For the treatment of interstitial lung disease"],"name":"ATYR0101"},"event_type":"Poster Presentation","id":"67374868759e09000118db63","nic_number":"","notes":"","outcome":"aTyr Pharma, Inc. announced that the Company will present two posters related to its tRNA synthetase candidate ATYR0101 at the Keystone Symposia on Fibrosis: Inflammation, Drivers, and Therapeutic Resolution, which is scheduled to take place December 8 – 11, 2024, in Whistler, British Columbia, Canada.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42006567/atyr-pharma-to-present-posters-on-trna-synthetase-candidate-atyr0101-at-keystone-symposia-on-fibro","source_type":"Press Release","status":"","target_date":"","time":"08:11:04","updated":1731676465},{"commentary":"","companies":[{"cik":"1708688","id":"603cef7eb9e30d000188fb85","name":"InflaRx NV","securities":[{"exchange":"NASDAQ","symbol":"IFRX"}]}],"created":1731675303,"date":"2024-11-15","drug":{"generic":false,"id":"607838fbfa13f900010012a2","indication_symptom":["Pyoderma Gangraenosum"],"name":"Vilobelimab"},"event_type":"Positive Opinion","id":"673744a7759e09000118daad","nic_number":"","notes":"","outcome":"InflaRx N.V. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization of GOHIBIC (vilobelimab), under exceptional circumstances for the treatment of adult patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation (IMV) (with or without extracorporeal membrane oxygenation (ECMO)).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42006361/inflarx-receives-positive-chmp-opinion-for-gohibic-vilobelimab-for-the-treatment-of-sars-cov-2-ind","source_type":"Press Release","status":"European Medicines Agency (EMA)","target_date":"","time":"07:55:03","updated":1731675821},{"commentary":"","companies":[{"cik":"310158","id":"603cef78b9e30d000188b9a4","name":"Merck \u0026 Co Inc","securities":[{"exchange":"NYSE","symbol":"MRK"}]}],"created":1731673222,"date":"2024-11-15","drug":{"generic":false,"id":"66571aaaf86556000186d477","indication_symptom":["For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma."],"name":"KEYNOTE-483"},"event_type":"Positive Opinion","id":"67373c866295c70001b97661","nic_number":"","notes":"","outcome":"Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42005204/merck-receives-positive-eu-chmp-opinion-for-keytruda-pembrolizumab-plus-chemotherapy-as-first-line","source_type":"Press Release","status":"","target_date":"","time":"07:20:22","updated":1731673284},{"commentary":"","companies":[{"cik":"1614744","id":"603cef7db9e30d000188eca2","name":"Purple Biotech 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The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b42004650/bristol-myers-squibb-receives-positive-chmp-opinion-for-repotrectinib-for-the-treatment-of-advance","source_type":"Press Release","status":"European Medicines Agency (EMA)","target_date":"","time":"07:02:04","updated":1731672346},{"commentary":"","companies":[{"cik":"1379006","id":"603cef7bb9e30d000188dbe6","name":"Nanoviricides Inc","securities":[{"exchange":"AMEX","symbol":"NNVC"}]}],"created":1731670481,"date":"2024-11-15","drug":{"generic":false,"id":"65536a7b7f07f10001c945eb","indication_symptom":["For MPox and Smallpox virus infections"],"name":"NV-387"},"event_type":"Provided Update","id":"673731d16295c70001b971c5","nic_number":"","notes":"","outcome":"NanoViricides, Inc provided clinical 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(FDA) has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g42000231/press-release-dupixent-sbla-accepted-for-fda-review-for-the-treatment-of-chronic-spontaneous-urtic","source_type":"Press Release","status":"supplemental Biologics License Applications (sBLA)","target_date":"","time":"05:27:55","updated":1731666639},{"commentary":"","companies":[{"cik":"872589","id":"603cef78b9e30d000188ba95","name":"Regeneron Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"REGN"}]},{"cik":"1121404","id":"603cef78b9e30d000188baf1","name":"Sanofi 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Administration (\"FDA\") for its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine (also known as \"Ara-C\" and for which the combination of Annamycin and Ara-C is referred to as \"AnnAraC\") for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41970787/moleculin-accelerates-planned-unblinded-data-readout-for-miracle-phase-3-rr-acute-myeloid-leukemia","source_type":"Press Release","status":"","target_date":"","time":"08:17:00","updated":1731590276},{"commentary":"","companies":[{"cik":"1513525","id":"603cef7eb9e30d000188fb41","name":"Adial Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ADIL"}]}],"created":1731589486,"date":"2024-11-14","drug":{"generic":false,"id":"60d4fdbd619f580001b6e0b5","indication_symptom":["Alcohol Use Disorder 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Lead authored by Dr. A. James Daveson, Gastroenterologist, Wesley Research Institute and Coral Sea Clinical Research Institute, Queensland, Australia, the paper is entitled, \"Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial.\"","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41934171/immunic-announces-publication-of-data-from-phase-11b-clinical-trial-of-imu-856-in-the-peer-reviewe","source_type":"Press Release","status":"Phase 1/1b","target_date":"","time":"06:35:20","updated":1731497792},{"commentary":"","companies":[{"cik":"1501697","id":"603cef7eb9e30d000188fb97","name":"X4 Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"XFOR"}]}],"created":1731497616,"date":"2024-11-13","drug":{"generic":false,"id":"6576bcd5a2fb150001c8fb42","indication_symptom":["In people diagnosed with idiopathic"," cyclic"," or congenital 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(LVAD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41901116/cadrenal-therapeutics-highlights-presentation-at-european-association-for-cardio-thoracic-surgery-","source_type":"Press Release","status":"","target_date":"","time":"09:39:20","updated":1731422835},{"commentary":"","companies":[{"cik":"1488039","id":"603cef7db9e30d000188ebd6","name":"Atossa Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"ATOS"}]}],"created":1731422360,"date":"2024-11-12","drug":{"generic":false,"id":"60be406cf0c52b0001fc6963","indication_symptom":["Breast Cancer"],"name":"Endoxifen"},"event_type":"Provided Update","id":"6733689891a4760001b2eef8","nic_number":"","notes":"","outcome":"Atossa Therapeutics, Inc. provided an update on recent company 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of care, versus the standard of care alone in a pivotal randomized Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41898476/tempest-receives-fda-study-may-proceed-for-pivotal-phase-3-trial-of-amezalpat-combination-therapy-","source_type":"Press Release","status":"","target_date":"","time":"08:19:27","updated":1731417914},{"commentary":"","companies":[{"cik":"894158","id":"603cef79b9e30d000188c44d","name":"Synthetic Biologics Inc","securities":[{"exchange":"AMEX","symbol":"SYN"}]}],"created":1731417567,"date":"2024-11-12","drug":{"generic":false,"id":"6076d7e82290f10001c6789c","indication_symptom":["Acute Graft-Versus-Host-Disease (aGVHD)"],"name":"SYN-004"},"event_type":"Provided Update","id":"673355dfb3805500018f760c","nic_number":"","notes":"","outcome":"Theriva™ Biologics provided a corporate 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Ara-C is referred to as \"AnnAraC\") for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41898465/moleculin-receives-institutional-review-board-approval-for-miracle-phase-3-pivotal-trial-of-annamy","source_type":"Press Release","status":"","target_date":"","time":"08:19:27","updated":1731417770},{"commentary":"","companies":[{"cik":"","id":"6638917ddb24d10001bc99be","name":"CG Oncology Inc","securities":[]}],"created":1731417567,"date":"2024-11-12","drug":{"generic":false,"id":"6630e50defec610001c22f7d","indication_symptom":["For the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in-situ (CIS) with or without Ta or T1 papillary tumors"],"name":"BOND-003"},"event_type":"Provided Update","id":"673355dfb3805500018f7610","nic_number":"","notes":"","outcome":"CG Oncology, Inc. provided business 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elraglusib, a novel GSK-3β inhibitor for treatment of Ewing sarcoma (EWS).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41898399/actuate-announces-fda-rare-pediatric-disease-designation-granted-to-elraglusib-for-treatment-of-ew","source_type":"Press Release","status":"Rare Pediatric Disease Designation (RPD)","target_date":"","time":"07:52:27","updated":1731417479},{"commentary":"","companies":[{"cik":"1649094","id":"603cef7fb9e30d0001890127","name":"Vaxcyte Inc","securities":[{"exchange":"NASDAQ","symbol":"PCVX"}]}],"created":1731415947,"date":"2024-11-12","drug":{"generic":false,"id":"64c0cdbe9c212e000152225a","indication_symptom":["For the Prevention of Invasive Pneumococcal Disease "],"name":"VAX-31"},"event_type":"Regulatory Update","id":"67334f8b36be820001986bf4","nic_number":"","notes":"","outcome":"Vaxcyte, Inc. announced positive regulatory updates, including the United States Food and Drug Administration (FDA) clearance of the VAX-31 infant 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trial of its lead product candidate, obexelimab, for the treatment of patients with IgG4-RD..","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41896656/zenas-biopharma-completes-targeted-enrollment-of-the-phase-3-indigo-trial-of-obexelimab-in-immunog","source_type":"Press Release","status":"Phase 3","target_date":"","time":"07:50:13","updated":1731416460},{"commentary":"","companies":[{"cik":"","id":"673350f491a4760001b2eb81","name":"Zenas BioPharma Inc","securities":[{"exchange":"NASDAQ","symbol":"ZBIO"}]}],"created":1731415813,"date":"2024-11-12","drug":{"generic":false,"id":"672b343a86a8560001f8f2fb","indication_symptom":[" Immunoglobulin G4-Related Disease (IgG4-RD)"],"name":"Obexelimab"},"event_type":"Top-line results","id":"67334f0536be820001986bca","nic_number":"","notes":"","outcome":"Zenas BioPharma, Inc announced that Topline INDIGO results expected by the end of 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T","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41887805/quince-therapeutics-presents-safety-data-from-prior-phase-3-attest-clinical-trial-at-53rd-child-ne","source_type":"Press Release","status":"Phase 3","target_date":"","time":"05:12:08","updated":1731406584},{"commentary":"","companies":[{"cik":"1661181","id":"603cef7eb9e30d000188f954","name":"Organogenesis Holdings Inc","securities":[{"exchange":"NASDAQ","symbol":"ORGO"}]}],"created":1731406211,"date":"2024-11-11","drug":{"generic":false,"id":"6630e6a1efec610001c230a8","indication_symptom":["For Knee Osteoarthritis"],"name":"ReNu"},"event_type":"Analysis","id":"6733298391a4760001b2e7a8","nic_number":"","notes":"","outcome":"Organogenesis Holdings Inc. announced the favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41889024/organogenesis-reports-positive-interim-analysis-of-second-phase-3-clinical-trial-of-renu-for-knee-","source_type":"Press Release","status":"Phase 3","target_date":"","time":"05:10:11","updated":1731406290},{"commentary":"","companies":[{"cik":"1000694","id":"603cef79b9e30d000188c0db","name":"Novavax Inc","securities":[{"exchange":"NASDAQ","symbol":"NVAX"}]}],"created":1731332043,"date":"2024-11-11","drug":{"generic":false,"id":"670fac294a361900010a30bc","indication_symptom":["for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. 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[Efgartigimod Alfa Injection (Subcutaneous Injection)] for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP). and argenx","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41875784/zai-lab-and-argenx-announce-approval-of-vyvgart-hytrulo-for-chronic-inflammatory-demyelinating-pol","source_type":"Press Release","status":"China National Medical Products Administration (NMPA) Approval","target_date":"","time":"07:35:53","updated":1731329019},{"commentary":"","companies":[{"cik":"1175151","id":"603cef7bb9e30d000188db18","name":"CytoSorbents Corp","securities":[{"exchange":"NASDAQ","symbol":"CTSO"}]}],"created":1731328553,"date":"2024-11-11","drug":{"generic":false,"id":"61392869b6abe40001f0526e","indication_symptom":["Critically Ill COVID-19 Patients on Extracorporeal Membrane Oxygenation (ECMO)"],"name":"CytoSorb"},"event_type":"Provided 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and combination dose escalation portions of the Phase 1/2 ABILITY-1 (A Beta-only IL-2 ImmunoTherapY) study evaluating MDNA11, a long-acting ‘beta-enhanced not-alpha' interleukin-2 (IL-2) super-agonist, as monotherapy or in combination with Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors, at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held in Houston, Texas, on November 9th, 2024..","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41875062/medicenna-announces-positive-single-agent-activity-of-mdna11-from-dose-expansion-cohort-and-encour","source_type":"Press Release","status":"","target_date":"","time":"07:20:28","updated":1731327683},{"commentary":"","companies":[{"cik":"1117480","id":"603cef7db9e30d000188f22e","name":"Chimerix 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of ELI-002, an Amphiphile (\"AMP\") cancer vaccine that targets KRAS-mutant tumors at the Society for Immunotherapy of Cancer (\"SITC\") 2024 Annual Meeting.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41823808/elicio-therapeutics-presents-updated-translational-data-from-eli-002-phase-1-amplify-7p-study-at-t","source_type":"Press Release","status":"Phase 1","target_date":"","time":"03:09:36","updated":1731053438},{"commentary":"","companies":[{"cik":"","id":"66f5419b6d02590001cb397a","name":"Mural Oncology plc","securities":[{"exchange":"NASDAQ","symbol":"MURA"}]}],"created":1731053200,"date":"2024-11-07","drug":{"generic":false,"id":"66fd3beec2ed5b00011dd696","indication_symptom":["For Solid Tumors"],"name":"nemvaleukin"},"event_type":"Poster Presentation","id":"672dc69091a4760001b2495f","nic_number":"","notes":"","outcome":"Mural Oncology plc announced three poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer 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"],"name":"TNG462"},"event_type":"Provided Update","id":"672b629a07f55e0001644598","nic_number":"","notes":"","outcome":"Tango Therapeutics, Inc announced an update on its PRMT5 program.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41769776/tango-therapeutics-reports-positive-tng462-clinical-data-and-provides-update-on-prmt5-development-","source_type":"Press Release","status":"","target_date":"","time":"07:35:38","updated":1730896612},{"commentary":"","companies":[{"cik":"","id":"603cef79b9e30d000188c56c","name":"BioRestorative Therapies Inc","securities":[]}],"created":1730896378,"date":"2024-11-06","drug":{"generic":false,"id":"62019623e008470001d6fdb0","indication_symptom":["Chronic Lumbar Disc Disease"],"name":"BRTX-100"},"event_type":"Provided Update","id":"672b61fa07f55e0001644574","nic_number":"","notes":"","outcome":"BioRestorative Therapies, announced that company will provide a business update on November 12, 2024 –","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41769746/biorestorative-therapies-to-present-new-clinical-data-at-the-ors-psrs-7th-international-spine-rese","source_type":"Press Release","status":"","target_date":"2024-11-12","time":"07:32:58","updated":1730896486},{"commentary":"","companies":[{"cik":"","id":"603cef79b9e30d000188c56c","name":"BioRestorative Therapies Inc","securities":[]}],"created":1730896378,"date":"2024-11-06","drug":{"generic":false,"id":"62019623e008470001d6fdb0","indication_symptom":["Chronic Lumbar Disc Disease"],"name":"BRTX-100"},"event_type":"Data Presentation","id":"672b61fa07f55e0001644572","nic_number":"","notes":"","outcome":"BioRestorative Therapies, announced that new preliminary 26–52 week blinded data from the ongoing Phase 2 clinical trial of BRTX-100 in subjects with chronic lumbar disc disease (\"cLDD\") will be presented by Francisco Silva, Vice President of Research and Development, at the Orthopaedic Research Society (ORS) Philadelphia Spine Research Society (PSRS) 7th International Spine Research Symposium, taking place November 10-14, 2024 in Skytop, Pennsylvania. BioRestorative will also make the data available through a public announcement.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41769746/biorestorative-therapies-to-present-new-clinical-data-at-the-ors-psrs-7th-international-spine-rese","source_type":"Press Release","status":"Phase 2","target_date":"","time":"07:32:58","updated":1730896486},{"commentary":"","companies":[{"cik":"1253689","id":"603cef7db9e30d000188f32d","name":"GlycoMimetics Inc","securities":[{"exchange":"NASDAQ","symbol":"GLYC"}]}],"created":1730896296,"date":"2024-11-06","drug":{"generic":false,"id":"671f7d9ad453ac0001621928","indication_symptom":["In adults with newly diagnosed acute myeloid leukemia "],"name":"Uproleselan"},"event_type":"Presentation","id":"672b61a807f55e000164455d","nic_number":"","notes":"","outcome":"GlycoMimetics, Inc announced that data from multiple clinical trials studying uproleselan in patients with acute myeloid leukemia (AML) have been accepted for presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Diego, California, on December 7-10, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41769769/glycomimetics-announces-new-uproleselan-clinical-data-will-be-presented-at-ash-annual-meeting","source_type":"Press Release","status":"","target_date":"","time":"07:31:36","updated":1730896354},{"commentary":"","companies":[{"cik":"","id":"672b29fb057896000129c880","name":"HUTCHMED (China) Limited","securities":[{"exchange":"NASDAQ","symbol":"HCM"}]}],"created":1730815589,"date":"2024-11-06","drug":{"generic":false,"id":"6728c21686a8560001f870ea","indication_symptom":["In adult patients with chronic primary immune thrombocytopenia"],"name":"ESLIM-01"},"event_type":"Updated data","id":"672a266586a8560001f8b532","nic_number":"","notes":"","outcome":"HUTCHMED (China) Limited announces that new and updated data from the sovleplenib ESLIM-01 Phase III trial, as well as several investigator-initiated studies of compounds discovered by HUTCHMED will be presented at the American Society of Hematology (\"ASH\") Annual Meeting taking place on December 7-10, 2024 in San Diego, USA, and the European Society for Medical Oncology (\"ESMO\") Asia Congress 2024, taking place on December 6-8, 2024 in Singapore.","outcome_brief":"","source_link":"https://www.hutch-med.com/2024-ash-esmo-asia/","source_type":"Press Release","status":"","target_date":"","time":"09:06:29","updated":1730882226},{"commentary":"","companies":[{"cik":"1651308","id":"603cef7eb9e30d000188f7e8","name":"BeiGene Ltd","securities":[{"exchange":"OTC","symbol":"BEIGF"},{"exchange":"NASDAQ","symbol":"BGNE"}]}],"created":1730885224,"date":"2024-11-05","drug":{"generic":false,"id":"66c48d64cf36400001781040","indication_symptom":["For adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)"],"name":"BGB-16673"},"event_type":"New Data","id":"672b3668057896000129c9be","nic_number":"","notes":"","outcome":"BeiGene, Ltd announced it will share new data across a range of B-cell malignancies and assets, including best-in-class Bruton's tyrosine kinase (BTK) inhibitor BRUKINSA® (zanubrutinib), at the 66th ASH Annual Meeting and Exposition in San Diego, December 7-10. BeiGene has 21 abstracts accepted at ASH 2024, with four selected for oral presentation.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41745455/beigene-highlights-innovative-hematology-portfolio-across-b-cell-malignancies-at-ash-2024","source_type":"Press Release","status":"","target_date":"","time":"04:27:04","updated":1730885866},{"commentary":"","companies":[{"cik":"","id":"62e1ada2b585e90001eff6af","name":"Century Therapeutics","securities":[{"exchange":"NASDAQ","symbol":"IPSC"}]}],"created":1730885224,"date":"2024-11-05","drug":{"generic":false,"id":"6307803c86af2600019282de","indication_symptom":["Relapsed or refractory CD19 positive B-cell malignancies"],"name":"CNTY-101"},"event_type":"Provided Update","id":"672b3668057896000129c9c0","nic_number":"","notes":"","outcome":"Century Therapeutics, reported business highlights","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745454/century-therapeutics-reports-third-quarter-2024-financial-results-and-provides-business-updates","source_type":"Press Release","status":"","target_date":"","time":"04:27:04","updated":1730885729},{"commentary":"","companies":[{"cik":"1422143","id":"603cef7eb9e30d000188f7a9","name":"Kura Oncology Inc","securities":[{"exchange":"NASDAQ","symbol":"KURA"}]}],"created":1730885224,"date":"2024-11-05","drug":{"generic":false,"id":"63e4ec275f23fa0001076b13","indication_symptom":["Treatment of genetically defined AML patients with high unmet need"],"name":"Ziftomenib"},"event_type":"Abstract","id":"672b3668057896000129c9c2","nic_number":"","notes":"","outcome":"- Kura Oncology, Inc announced that two abstracts highlighting clinical data from the KOMET-007 combination trial of ziftomenib, the Company's potent and selective menin inhibitor, have been accepted for presentation at the upcoming American Society of Hematology (ASH) Annual Meeting, to be held in San Diego from December 7-10, 2024..","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745694/kura-oncology-to-present-updated-data-from-komet-007-combination-trial-of-ziftomenib-at-ash-annual","source_type":"Press Release","status":"","target_date":"","time":"04:27:04","updated":1730885586},{"commentary":"","companies":[{"cik":"1737287","id":"603cef7eb9e30d000188fda5","name":"Allogene Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"ALLO"}]}],"created":1730885224,"date":"2024-11-05","drug":{"generic":false,"id":"610b28c9a3c6b90001e8cbc1","indication_symptom":["Advanced or Metastatic Renal Cell Carcinoma"],"name":"ALLO-316"},"event_type":"Data Presentation","id":"672b3668057896000129c9c6","nic_number":"","notes":"","outcome":"Allogene Therapeutics, Inc announced that it will present new data from the ongoing Phase 1 TRAVERSE trial at the 2024 International Kidney Cancer Symposium (IKCS) and the Society for Immunotherapy of Cancer's (SITC) annual meeting.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745727/allogene-therapeutics-to-present-new-data-demonstrating-the-potential-of-allo-316-in-heavily-pretr","source_type":"Press Release","status":"Phase 1","target_date":"","time":"04:27:04","updated":1730885507},{"commentary":"","companies":[{"cik":"1801198","id":"603cef7fb9e30d0001890118","name":"Legend Biotech Corp","securities":[{"exchange":"NASDAQ","symbol":"LEGN"}]}],"created":1730885224,"date":"2024-11-05","drug":{"generic":false,"id":"608c7ea7d46fa800011d7bdd","indication_symptom":["Relapsed and/or Refractory Multiple Myeloma"],"name":"Ciltacabtagene Autoleucel (cilta-cel)"},"event_type":"Data Presentation","id":"672b3668057896000129c9c4","nic_number":"","notes":"","outcome":"Legend Biotech Corporation will present new data on minimal residual disease (MRD) negativity rates from the Phase 3 CARTITUDE-4 trial in multiple myeloma patients treated with CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) versus standard of care (SoC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745698/legend-biotech-to-unveil-minimal-residual-disease-data-from-landmark-cartitude-4-trial-in-multiple","source_type":"Press Release","status":"Phase 3","target_date":"","time":"04:27:04","updated":1730885495},{"commentary":"","companies":[{"cik":"","id":"611eb30db4035700018bcb32","name":"TScan Therapeutics, Inc.","securities":[{"exchange":"NASDAQ","symbol":"TCRX"}]}],"created":1730885150,"date":"2024-11-05","drug":{"generic":false,"id":"611d6aebb6abe40001ee931b","indication_symptom":["Solid tumors"],"name":"TSC-100"},"event_type":"Results","id":"672b361e057896000129c9a2","nic_number":"","notes":"","outcome":"TScan Therapeutics, Inc. announced that preliminary results from the ALLOHA™ Phase 1 trial of TSC-100 and TSC-101, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT) with reduced intensity conditioning, will be featured in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 7 – 10 in San Diego, CA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745927/tscan-therapeutics-announces-upcoming-oral-presentation-of-data-from-the-alloha-phase-1-heme-trial","source_type":"Press Release","status":"Phase 1","target_date":"","time":"04:25:50","updated":1730885221},{"commentary":"","companies":[{"cik":"1595248","id":"603cef7eb9e30d000188fb0d","name":"Genprex Inc","securities":[{"exchange":"NASDAQ","symbol":"GNPX"}]}],"created":1730884128,"date":"2024-11-05","drug":{"generic":false,"id":"66deea6f6d02590001c8e41d","indication_symptom":["For the treatment of Ras inhibitor resistant lung cancer"," mesothelioma and glioblastoma."],"name":"Reqorsa® Gene Therapy"},"event_type":"Poster Presentation","id":"672b3220057896000129c958","nic_number":"","notes":"","outcome":"- Genprex, Inc. announced that its research collaborators at Meharry Medical College will present a poster detailing positive preclinical data from a study of the Company's lead drug candidate, Reqorsa® Gene Therapy (quaratusugene ozeplasmid) evaluating TUSC2's role in modulating immune responses in cancer.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41746334/genprex-collaborators-present-positive-preclinical-data-on-reqorsa-gene-therapy-at-the-society-for","source_type":"Press Release","status":"","target_date":"","time":"04:08:48","updated":1730885088},{"commentary":"","companies":[{"cik":"","id":"61bbab433519e4000124f5eb","name":"Lyell Immunopharma, Inc.","securities":[{"exchange":"NASDAQ","symbol":"LYEL"}]}],"created":1730884128,"date":"2024-11-05","drug":{"generic":false,"id":"672b3465057896000129c96f","indication_symptom":["For the treatment of B-cell Lymphoma"],"name":"IMPT-314"},"event_type":"Abstract","id":"672b3220057896000129c95a","nic_number":"","notes":"","outcome":"Lyell Immunopharma, Inc. announced that an abstract highlighting initial clinical data from the Phase 1-2 study of IMPT-314 in large B-cell lymphoma will be presented by Sarah M. Larson, M.D., Associate Professor, Department of Medicine, Medical Director, Immune Effector Cell Therapy Program, Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, at the 66th American Society of Hematology (ASH) Annual Meeting taking place in San Diego, CA, December 7 – 10, 2024. IMPT-314 is a dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate being developed for patients with aggressive B-cell non-Hodgkin's lymphoma.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41746356/lyell-announces-presentation-of-initial-clinical-data-from-the-phase-1-2-clinical-trial-of-impt-31","source_type":"Press Release","status":"","target_date":"","time":"04:08:48","updated":1730884842},{"commentary":"","companies":[{"cik":"","id":"65266f4cb6b19d00018a76c0","name":"MAIA Biotechnology Inc","securities":[]}],"created":1730884129,"date":"2024-11-05","drug":{"generic":false,"id":"669f98e8d9891400015004aa","indication_symptom":["In patients with advanced non-small cell lung cancer (NSCLC) "],"name":"THIO-101"},"event_type":"Abstract","id":"672b3221057896000129c95c","nic_number":"","notes":"","outcome":"MAIA Biotechnology, Inc announced that a late-breaking abstract (LBA) detailing new updates from its Phase 2 THIO-101 clinical trial was selected for oral and poster presentation at the 2024 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held November 6-10, 2024, in Houston, Texas.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41746780/maia-biotechnology-announces-late-breaking-abstract-of-thio-101-updates-selected-for-oral-and-post","source_type":"Press Release","status":"Phase 2","target_date":"","time":"04:08:49","updated":1730884532},{"commentary":"","companies":[{"cik":"1771910","id":"603cef7eb9e30d000188ffc6","name":"ADC Therapeutics SA","securities":[{"exchange":"NYSE","symbol":"ADCT"}]}],"created":1730884129,"date":"2024-11-05","drug":{"generic":false,"id":"60831d6aeb87ad0001ba2598","indication_symptom":["Refractory Diffuse Large B-Cell Lymphoma"],"name":"ZYNLONTA (loncastuximab tesirine-lpyl)"},"event_type":"Presentation","id":"672b3221057896000129c95e","nic_number":"","notes":"","outcome":"ADC Therapeutics SA announced independent, investigator-initiated study abstracts on ZYNLONTA® (loncastuximab tesirine-lpyl) have been accepted for presentation at the 66th American Society of Hematology (ASH) Annual Meeting, which will be held in San Diego, California from December 7-10, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41746868/adc-therapeutics-announces-investigator-initiated-study-abstracts-accepted-for-presentation-at-the","source_type":"Press Release","status":"","target_date":"","time":"04:08:49","updated":1730884460},{"commentary":"","companies":[{"cik":"1390478","id":"603cef7bb9e30d000188da03","name":"SELLAS Life Sciences Group Inc","securities":[{"exchange":"NASDAQ","symbol":"SLS"}]}],"created":1730884129,"date":"2024-11-05","drug":{"generic":false,"id":"651d470508e89000019cfd7a","indication_symptom":[" For Treatment of Acute Myeloid Leukemia"],"name":"SLS009"},"event_type":"Data","id":"672b3221057896000129c960","nic_number":"","notes":"","outcome":"SELLAS Life Sciences Group, Inc. announced that data from its Phase 2a trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) will be presented at the 66th American Society of Hematology (ASH) Annual Meeting \u0026 Exposition, which is being held on December 7 –10, 2024, in San Diego, California.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41747051/sellas-life-sciences-to-present-at-the-66th-american-society-of-hematology-ash-annual-meeting-expo","source_type":"Press Release","status":"Phase 2a","target_date":"","time":"04:08:49","updated":1730884382},{"commentary":"","companies":[{"cik":"","id":"603cef7db9e30d000188f5ea","name":"Molecular Partners AG","securities":[]}],"created":1730883660,"date":"2024-11-05","drug":{"generic":false,"id":"65416eca38f519000132dd17","indication_symptom":[" For the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndrome (AML/MDS)."],"name":"MP0533"},"event_type":"Data Presentation","id":"672b304c057896000129c939","nic_number":"","notes":"","outcome":"Molecular Partners AG announced the presentation of data from its MP0533 and MP0621 programs at the upcoming Annual Meeting of the American Society of Hematology (ASH) in San Diego, running December 7–10, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41757315/molecular-partners-announces-upcoming-poster-presentations-at-the-65th-ash-annual-meeting-and-expo","source_type":"Press Release","status":"","target_date":"","time":"04:01:00","updated":1730883750},{"commentary":"","companies":[{"cik":"1395937","id":"603cef7db9e30d000188f47d","name":"Syndax Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"SNDX"}]}],"created":1730883375,"date":"2024-11-05","drug":{"generic":false,"id":"6516c5db9705270001e211c8","indication_symptom":["Relapsed/Refractory KMT2Ar Acute 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polycythemia vera will be the focus of a poster presentation at the 66th Annual American Society of Hematology (ASH) Annual Meeting being held in San Diego from December 7-10, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/ac41757847/protagonist-therapeutics-announces-poster-presentation-on-final-revive-phase-2-study-data-with-ru","source_type":"Press Release","status":"Phase 2","target_date":"","time":"03:53:17","updated":1730883383},{"commentary":"","companies":[{"cik":"1062822","id":"603cef78b9e30d000188b91c","name":"Lexicon Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"LXRX"}]}],"created":1730882932,"date":"2024-11-05","drug":{"generic":false,"id":"6489b22c38ab3c0001934f60","indication_symptom":["INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). 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Inc","securities":[{"exchange":"NASDAQ","symbol":"CPIX"}]}],"created":1730882410,"date":"2024-11-05","drug":{"generic":false,"id":"61a55db16788ac00012ad4df","indication_symptom":["Pre-Operative Administration"],"name":"Caldolor"},"event_type":"Publication","id":"672b2b6a057896000129c8b2","nic_number":"","notes":"","outcome":"Cumberland Pharmaceuticals announced the publication of new real-world outcomes research demonstrating the safety and healthcare resource advantages of its Caldolor (ibuprofen) injection over ketorolac in both adult and pediatric populations.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41757653/new-study-compares-caldolor-ibuprofen-injection-to-ketorolac","source_type":"Press Release","status":"","target_date":"","time":"03:40:10","updated":1730882460},{"commentary":"","companies":[{"cik":"1661059","id":"603cef7eb9e30d000188feda","name":"NextCure 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2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745453/agios-to-present-new-data-on-mitapivat-and-tebapivat-in-rare-blood-disorders-at-66th-ash-annual-me","source_type":"Press Release","status":"","target_date":"","time":"09:20:13","updated":1730817147},{"commentary":"","companies":[{"cik":"","id":"67090ae22e086c0001c9788e","name":"Turnstone Biologics Corp","securities":[{"exchange":"NASDAQ","symbol":"TSBX"}]}],"created":1730816413,"date":"2024-11-05","drug":{"generic":false,"id":"6708408f4a36190001451434","indication_symptom":["In patients with colorectal cancer"," head and neck cancer"," and uveal melanoma."],"name":"TIDAL-01"},"event_type":"Poster Presentation","id":"672a299d113bde00011a4573","nic_number":"","notes":"","outcome":"Turnstone Biologics Corp. announced it will be presenting two posters highlighting preclinical data on methods for TIL selection at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting being held November 6-10, 2024 in Houston, Texas.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745254/turnstone-biologics-presents-preclinical-data-highlighting-potential-for-selected-tumor-infiltrati","source_type":"Press Release","status":"","target_date":"","time":"09:20:13","updated":1730817016},{"commentary":"","companies":[{"cik":"","id":"6137a141b4035700018d3851","name":"Candel Therapeutics, Inc.","securities":[{"exchange":"NASDAQ","symbol":"CADL"}]}],"created":1730816414,"date":"2024-11-05","drug":{"generic":false,"id":"61390a11b4035700018d5a7f","indication_symptom":["Recurrent high-grade Glioma"],"name":"CAN-3110"},"event_type":"Results","id":"672a299e113bde00011a4575","nic_number":"","notes":"","outcome":"Candel Therapeutics, Inc. announced preclinical results and therapeutic potential of CAN-3110 in the Ras-Raf pathway altered melanoma model.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745134/candel-therapeutics-to-present-preclinical-data-at-sitc-annual-meeting-showing-promise-for-can-311","source_type":"Press Release","status":"","target_date":"","time":"09:20:14","updated":1730816929},{"commentary":"","companies":[{"cik":"1745999","id":"603cef7eb9e30d000188ffe5","name":"Beam Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"BEAM"}]}],"created":1730816414,"date":"2024-11-05","drug":{"generic":false,"id":"609ad809f7862d0001da54f4","indication_symptom":["Sickle cell diseas"],"name":"BEAM-101"},"event_type":"Oral presentation","id":"672a299e113bde00011a4577","nic_number":"","notes":"","outcome":"Beam Therapeutics Inc. announced the acceptance of multiple oral and poster presentations, including the first clinical data from a Beam program, at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 7-10, 2024, in San Diego.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745039/beam-therapeutics-to-present-data-across-hematology-franchise-including-first-clinical-data-for-be","source_type":"Press Release","status":"","target_date":"","time":"09:20:14","updated":1730816875},{"commentary":"","companies":[{"cik":"1662579","id":"603cef7fb9e30d000189024c","name":"C4 Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"CCCC"}]}],"created":1730816414,"date":"2024-11-05","drug":{"generic":false,"id":"6565d6962803140001e08890","indication_symptom":["For the potential treatment of relapsed/refractory multiple myeloma and relapsed/refractory non-Hodgkin's lymphoma."],"name":"CFT7455"},"event_type":"Abstract","id":"672a299e113bde00011a4579","nic_number":"","notes":"","outcome":"C4 Therapeutics, Inc announced that two abstracts from the ongoing Phase 1/2 trial of cemsidomide have been accepted for presentation at the ASH Annual Meeting taking place from December 7 – 10, 2024 in San Diego, California.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745020/c4-therapeutics-to-present-data-from-the-ongoing-phase-12-trial-of-cemsidomide-in-multiple-myeloma","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"09:20:14","updated":1730816751},{"commentary":"","companies":[{"cik":"1730463","id":"603cef7eb9e30d000188fcb4","name":"Autolus Therapeutics PLC","securities":[{"exchange":"NASDAQ","symbol":"AUTL"}]}],"created":1730816414,"date":"2024-11-05","drug":{"generic":false,"id":"609480945c2ffa000106e539","indication_symptom":["Adult Acute lymphoblastic leukemia (ALL) "],"name":"Obe-cel (AUTO1 - ALLCAR19) ALL"},"event_type":"Publication","id":"672a299e113bde00011a457b","nic_number":"","notes":"","outcome":"Autolus Therapeutics announces the online publication of four abstracts submitted to the American Society of Hematology (ASH) Annual Meeting, to be held from December 7-10, 2024, in San Diego.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745010/autolus-therapeutics-to-present-clinical-data-updates-at-the-american-society-of-hematology-ash-an","source_type":"Press Release","status":"","target_date":"","time":"09:20:14","updated":1730816675},{"commentary":"","companies":[{"cik":"","id":"6578048d78910a00010e1da7","name":"Disc Medicine Inc","securities":[]}],"created":1730816414,"date":"2024-11-05","drug":{"generic":false,"id":"65d4b021fd3dd800013d8682","indication_symptom":["For the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease"],"name":"DISC-0974"},"event_type":"Data Presentation","id":"672a299e113bde00011a457d","nic_number":"","notes":"","outcome":"Disc Medicine, Inc. announced that it will present data from multiple programs in its hematology portfolio at the upcoming American Society of Hematology (ASH) Annual Meeting, which will be held in San Diego, CA on December 7-10, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745038/disc-medicine-announces-multiple-presentations-across-portfolio-at-the-66th-american-society-of-he","source_type":"Press Release","status":"","target_date":"","time":"09:20:14","updated":1730816588},{"commentary":"","companies":[{"cik":"886744","id":"603cef78b9e30d000188b895","name":"Geron Corp","securities":[{"exchange":"NASDAQ","symbol":"GERN"}]}],"created":1730816414,"date":"2024-11-05","drug":{"generic":false,"id":"64919c2338ab3c000193ef40","indication_symptom":["Telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies."],"name":"Imetelstat"},"event_type":"Publication","id":"672a299e113bde00011a457f","nic_number":"","notes":"","outcome":"Geron Corporation announced the publication of abstracts containing new data highlighting the potential of RYTELO™ (imetelstat), a first-in-class telomerase inhibitor, in myeloid hematologic malignancies. Six abstracts have been accepted for presentation at the 66th American Society of Hematology (ASH) Annual Meeting taking place from December 7-10, 2024, in San Diego, California and virtually.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41745044/geron-announces-new-data-to-be-presented-at-upcoming-ash-annual-meeting-highlighting-the-potential","source_type":"Press Release","status":"","target_date":"","time":"09:20:14","updated":1730816512},{"commentary":"","companies":[{"cik":"","id":"62797789d52f390001d539f1","name":"Arcellx, Inc.","securities":[{"exchange":"NASDAQ","symbol":"ACLX"}]}],"created":1730815589,"date":"2024-11-05","drug":{"generic":false,"id":"6728c21686a8560001f870ec","indication_symptom":["In patients with relapsed or refractory multiple myeloma"],"name":"anitocabtagene autoleucel"},"event_type":"Data Presentation","id":"672a266586a8560001f8b534","nic_number":"","notes":"","outcome":"Arcellx, Inc announced that it will present clinical data in a poster presentation from its Phase 1 study (abstract #4825) of anitocabtagene autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma (RRMM); preliminary clinical data in an oral presentation from its iMMagine-1 study (abstract #1031) in patients with RRMM; and a health-related quality of life systematic literature review and meta-analysis (abstract #4721) in patients with RRMM in a poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 7-10, 2024, in San Diego, California.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41745089/arcellx-to-present-clinical-data-for-its-phase-1-and-immagine-1-studies-in-patients-with-relapsed-","source_type":"Press Release","status":"Phase 1","target_date":"","time":"09:06:29","updated":1730816202},{"commentary":"","companies":[{"cik":"1498403","id":"603cef7cb9e30d000188e65b","name":"BioLine Rx 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California.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41745078/biolinerx-announces-oral-presentation-on-data-from-phase-1-clinical-trial-evaluating-motixafortide","source_type":"Press Release","status":"","target_date":"","time":"09:06:29","updated":1730816018},{"commentary":"","companies":[{"cik":"","id":"6113ec99b6abe40001edcd68","name":"IN8bio Inc.","securities":[{"exchange":"NASDAQ","symbol":"INAB"}]}],"created":1730815584,"date":"2024-11-05","drug":{"generic":false,"id":"6113ec43a3c6b90001e9ab65","indication_symptom":["Leukemia undergoing haploidentical stem cell transplant (HSCT)"],"name":"INB-100"},"event_type":"Poster Presentation","id":"672a266086a8560001f8b529","nic_number":"","notes":"","outcome":"IN8bio, Inc announced an upcoming poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being hosted December 7 – 10, 2024 in San Diego, CA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745012/in8bio-announces-upcoming-presentation-at-the-2024-american-society-of-hematology-ash-annual-meeti","source_type":"Press Release","status":"","target_date":"","time":"09:06:24","updated":1730815949},{"commentary":"","companies":[{"cik":"","id":"659443f4b02d410001314f87","name":"Cartesian Therapeutics inc","securities":[]}],"created":1730815588,"date":"2024-11-05","drug":{"generic":false,"id":"659be731b3d44200013af59a","indication_symptom":["For autoimmune diseases"],"name":"Descartes-08"},"event_type":"Safety Data","id":"672a266486a8560001f8b52c","nic_number":"","notes":"","outcome":"Cartesian Therapeutics, announced that safety and tolerability data from patients treated with Descartes-08 will be featured during a poster presentation at the upcoming 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7-10, 2024 in San Diego.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745026/cartesian-therapeutics-announces-presentation-at-the-upcoming-66th-ash-annual-meeting","source_type":"Press Release","status":"","target_date":"","time":"09:06:28","updated":1730815892},{"commentary":"","companies":[{"cik":"1724521","id":"603cef7eb9e30d000188fc31","name":"Arcus Biosciences Inc","securities":[{"exchange":"NYSE","symbol":"RCUS"}]}],"created":1730815588,"date":"2024-11-05","drug":{"generic":false,"id":"67221b4b47411f0001bc18f8","indication_symptom":["For Immunotherapy of Cancer"],"name":"ARC-10"},"event_type":"Results","id":"672a266486a8560001f8b52e","nic_number":"","notes":"","outcome":"Arcus Biosciences, Inc. announced results from Part 1 of ARC-10, a randomized, open-label, three-arm study evaluating domvanalimab, an Fc-silent anti-TIGIT monoclonal antibody, plus zimberelimab, an anti-PD-1 monoclonal antibody, (DZ) versus zimberelimab (Z) or chemotherapy in patients with front-line locally advanced or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥50% without the presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41745117/arcus-biosciences-announces-that-domvanalimab-plus-zimberelimab-improved-overall-survival-in-arc-1","source_type":"Press Release","status":"","target_date":"","time":"09:06:28","updated":1730815834},{"commentary":"","companies":[{"cik":"1741830","id":"603cef7fb9e30d000189026e","name":"Kronos Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"KRON"}]}],"created":1730815588,"date":"2024-11-05","drug":{"generic":false,"id":"6728c21686a8560001f870ee","indication_symptom":[" For multiple myeloma as well as HPV-driven tumors. "],"name":"KB-9558"},"event_type":"Data Presentation","id":"672a266486a8560001f8b530","nic_number":"","notes":"","outcome":"Kronos Bio, Inc announced that it will present preclinical data from its p300 KAT inhibitor program for multiple myeloma at the American Society of Hematology (ASH) Annual Meeting taking place in San Diego, California from December 7 to 10, 2024. ","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745092/kronos-bio-to-present-data-at-the-ash-annual-meeting-from-p300-kat-inhibition-program-in-multiple-","source_type":"Press Release","status":"","target_date":"","time":"09:06:28","updated":1730815689},{"commentary":"","companies":[{"cik":"1119774","id":"603cef78b9e30d000188be09","name":"Compugen Ltd","securities":[{"exchange":"NASDAQ","symbol":"CGEN"}]}],"created":1730815462,"date":"2024-11-05","drug":{"generic":false,"id":"608b19eed46fa80001135de0","indication_symptom":["Solid tumors "],"name":"COM701"},"event_type":"Publication","id":"672a25e60578960001298ce3","nic_number":"","notes":"","outcome":"Compugen Ltd. announced that data supporting the anti-tumor activity and safety profile of the triple combination COM701, COM902 and pembrolizumab in advanced heavily pre-treated patients with platinum resistant ovarian cancer (PROC) has been published as an abstract released by the Society for Immunotherapy of Cancer (SITC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41745095/compugen-to-present-anti-tumor-activity-and-safety-data-of-com701-com902-and-pembrolizumab-combina","source_type":"Press Release","status":"","target_date":"","time":"09:04:22","updated":1730815561},{"commentary":"","companies":[{"cik":"1447028","id":"603cef7ab9e30d000188cadc","name":"Arbutus Biopharma Corp","securities":[{"exchange":"NASDAQ","symbol":"ABUS"}]}],"created":1730815372,"date":"2024-11-05","drug":{"generic":false,"id":"6447bc5eaaeafc00016071c5","indication_symptom":["Oral PD-L1 inhibitor"],"name":"AB-101"},"event_type":"Abstract","id":"672a258c0578960001298cca","nic_number":"","notes":"","outcome":"Affimed N.V. announced three abstracts on two of its innate cell engagers (ICE®) are accepted for presentation at the 66th ASH Annual Meeting and Exposition taking place December 7-10, 2024, in San Diego, California.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41745093/affimed-announces-acceptance-of-three-abstracts-at-the-2024-ash-annual-meeting-including-an-oral-p","source_type":"Press Release","status":"","target_date":"","time":"09:02:52","updated":1730815446},{"commentary":"","companies":[{"cik":"863894","id":"603cef78b9e30d000188b803","name":"Veru Inc","securities":[{"exchange":"NASDAQ","symbol":"VERU"}]}],"created":1730815263,"date":"2024-11-05","drug":{"generic":false,"id":"608037406664be0001d93ecc","indication_symptom":["ER+/HER2- breast cancer"],"name":"Enobosarm"},"event_type":"Presentation","id":"672a251f0578960001298caf","nic_number":"","notes":"","outcome":"Veru Inc announced data from a meta-analysis presentation at ObesityWeek, which took place November 5, 2024, in San Antonio, Texas.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41743999/veru-announces-meta-analysis-of-body-composition-data-from-older-patients-with-obesity-which-suppo","source_type":"Press Release","status":"","target_date":"","time":"09:01:03","updated":1730815352},{"commentary":"","companies":[{"cik":"1621221","id":"603cef7eb9e30d000188f7dd","name":"Artelo Biosciences Inc","securities":[{"exchange":"NASDAQ","symbol":"ARTL"}]}],"created":1730815102,"date":"2024-11-05","drug":{"generic":false,"id":"64f86125add8280001ff7b2b","indication_symptom":[" For the prevention of chemotherapy-induced peripheral neuropathy"," a debilitating and often treatment-altering side effect of cancer therapy."],"name":"ART26.12"},"event_type":"Provided Update","id":"672a247e0578960001298c90","nic_number":"","notes":"","outcome":"Artelo Biosciences, announced that ART26.12, the Company's lead clinical FABP inhibitor, has been accepted into the NIH Helping to End Addiction Long Term (HEAL) Initiative's Preclinical Screening Platform for Pain (PSPP).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41744006/artelo-biosciences-announces-acceptance-of-art26-12-into-the-national-institutes-of-healths-precli","source_type":"Press Release","status":"","target_date":"","time":"08:58:22","updated":1730815151},{"commentary":"","companies":[{"cik":"1693011","id":"603cef7fb9e30d0001890185","name":"Inozyme Pharma Inc","securities":[{"exchange":"NASDAQ","symbol":"INZY"}]}],"created":1730815024,"date":"2024-11-05","drug":{"generic":false,"id":"60f8061e48f06700014e16b8","indication_symptom":["ABCC6 Deficiency"],"name":"INZ-701"},"event_type":"Provided Update","id":"672a24300578960001298c7b","nic_number":"","notes":"","outcome":"Inozyme Pharma, provided business 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registration-directed Phase 3 development for the acute treatment of the disorder, and two additional non-systemic intranasal pherine product candidates in its neuroscience pipeline, itruvone in Phase 2 development for major depressive disorder and hormone-free PH80 in Phase 2 development for the management of vasomotor symptoms (hot flashes) due to menopause, at the 2024 Neuroscience Education Institute (NEI) Congress in Colorado Springs, Colorado from November 7 to 10, 2024.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/b41744010/vistagen-to-present-at-the-2024-neuroscience-education-institute-congress","source_type":"Press Release","status":"","target_date":"","time":"08:53:35","updated":1730815004},{"commentary":"","companies":[{"cik":"1205922","id":"603cef7eb9e30d000188fd38","name":"Vaccinex 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metabolic dysfunction-associated steatohepatitis (MASH).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/n41711611/neurobo-pharmaceuticals-completes-last-patient-last-visit-in-its-phase-2a-clinical-trial-evaluatin","source_type":"Press Release","status":"Phase 2a","target_date":"","time":"08:21:34","updated":1730727478},{"commentary":"","companies":[{"cik":"1062822","id":"603cef78b9e30d000188b91c","name":"Lexicon Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"LXRX"}]}],"created":1730726513,"date":"2024-11-04","drug":{"generic":false,"id":"6728c21786a8560001f870f2","indication_symptom":[" For obesity and weight loss"],"name":"LX9851"},"event_type":"Data Presentation","id":"6728ca713ecbfc0001b0104d","nic_number":"","notes":"","outcome":"Lexicon announced it will present data from two studies related to LX9851, its investigational compound for obesity and weight loss, at Obesity Week 2024, November 3-5, 2024, at the Henry B. 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Inc.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41711186/disc-medicine-announces-successful-end-of-phase-2-meeting-with-fda-for-bitopertin-in-erythropoieti","source_type":"Press Release","status":"Meeting With FDA","target_date":"","time":"08:21:55","updated":1730726773},{"commentary":"","companies":[{"cik":"911216","id":"603cef79b9e30d000188c149","name":"Palatin Technologies Inc","securities":[{"exchange":"AMEX","symbol":"PTN"}]}],"created":1730726515,"date":"2024-11-04","drug":{"generic":false,"id":"6728c21786a8560001f870f6","indication_symptom":["For the treatment of various metabolic disorders."],"name":"PL7737"},"event_type":"Poster Presentation","id":"6728ca733ecbfc0001b01059","nic_number":"","notes":"","outcome":"Palatin Technologies announced that preclinical data from the Company's melanocortin 4 receptor (MC4R) selective PL7737 obesity program will be highlighted in a poster presentation at ObesityWeek® 2024, the annual meeting of the Obesity Society held in San Antonio, Texas. 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schizophrenia.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41693596/teva-presents-latest-schizophrenia-treatment-research-including-phase-3-solaris-trial-results-demo","source_type":"Press Release","status":"Phase 3","target_date":"","time":"16:48:45","updated":1730494244},{"commentary":"","companies":[{"cik":"1723069","id":"603cef7ab9e30d000188d17e","name":"Tiziana Life Sciences PLC","securities":[{"exchange":"OTC","symbol":"TIZAF"},{"exchange":"NASDAQ","symbol":"TLSA"}]}],"created":1730493975,"date":"2024-11-01","drug":{"generic":false,"id":"60ad4999dbe0bc0001fc41dd","indication_symptom":["Crohn's disease with decreases in the classic side effects of cytokine release syndrome"],"name":"Foralumab"},"event_type":"Provided Update","id":"67253e1786a8560001f85ec9","nic_number":"","notes":"","outcome":"Tiziana Life Sciences, Ltd. announced its participation in the BIO-Europe 2024 conference, taking place November 4-6 in Stockholm, Sweden. 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A copy of the Company's presentation is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/24/11/g41679871/tonix-pharmaceuticals-presented-data-on-potential-mpox-vaccine-tnx-801-at-world-vaccine-congress-e","source_type":"Press Release","status":"","target_date":"","time":"07:50:47","updated":1730461890}],"includeAGGridStyles":true,"initialDateRange":{"date_from":"2024-11-01","date_to":"2024-11-30"},"initialTab":null,"metaProps":{"author":"Benzinga","canonical":"https://www.benzinga.com/fda-calendar","dateCreated":"2024-11-26T15:39:05.483Z","description":"Updated daily, the FDA calendar gives you insight into FDA actions on companies and upcoming actions the FDA is expected to take. 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They are designed to serve as a ‘one-stop shop’ for data needs of investors, both existing and potential, to capitalize on the opportunities these catalysts throw up or cut the losses from an adverse development.\u0026nbsp;\u003c/p\u003e\n","html":"The calendar allows data screening, based on company names or tickers, events, date-wise or based on a date range. They are designed to serve as a ‘one-stop shop’ for data needs of investors, both existing and potential, to capitalize on the opportunities these catalysts throw up or cut the losses from an adverse development.\u0026nbsp;","tag":"p","type":"default"},{"blockName":"core/heading","attrs":{"data":[]},"innerBlocks":[],"innerHTML":"\n\u003ch2\u003eWhat is a Catalyst?\u003c/h2\u003e\n","tag":"h2","id":"what-is-a-catalyst","html":"What is a Catalyst?","type":"default"},{"blockName":"core/paragraph","attrs":{"data":[]},"innerBlocks":[],"innerHTML":"\n\u003cp\u003eA catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes.\u0026nbsp;\u003c/p\u003e\n","html":"A catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes.\u0026nbsp;","tag":"p","type":"default"},{"blockName":"core/heading","attrs":{"data":[]},"innerBlocks":[],"innerHTML":"\n\u003ch2\u003e\u003cstrong\u003eBiotech Stock Movers\u003c/strong\u003e\u003c/h2\u003e\n","tag":"h2","id":"biotech-stock-movers","html":"\u003cstrong\u003eBiotech Stock Movers\u003c/strong\u003e","type":"default"},{"blockName":"core/paragraph","attrs":{"data":[]},"innerBlocks":[],"innerHTML":"\n\u003cp\u003eRegulatory actions and clinical readouts are stock-moving catalysts. The magnitude of the impact is usually disproportionate. Most clinical-stage biotechs, or companies which are yet to commercialize a product, do not generate revenues. The exceptions are those which may have out-licensed therapies-in-development to another company and as a result generate revenues in the form of licensing revenues. So, it will be years of investment (time money and efforts) into drug development, which usually takes about 10-15 years, on the promise of generating future returns.\u003c/p\u003e\n","html":"Regulatory actions and clinical readouts are stock-moving catalysts. The magnitude of the impact is usually disproportionate. Most clinical-stage biotechs, or companies which are yet to commercialize a product, do not generate revenues. The exceptions are those which may have out-licensed therapies-in-development to another company and as a result generate revenues in the form of licensing revenues. 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The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company.\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003ePDUFA was passed in the U.S. in 1992, which allows the FDA to collect fees from the sponsor company to fund the review process.\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional clinical studies to establish the efficacy and/or safety of the treatment option, problems with chemistry, manufacturing and controls, etc.\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA delay in the review period may stem from the FDA needs additional time to review any additional data/information that may have been tabled subsequent to the submission of the regulatory application or the FDA’s inability to complete site inspections where the drug ingredients are being made etc.\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eThe FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. 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