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FDA Calendar and Recent FDA News - Benzinga
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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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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-isHgOQ jueBjR"><div class="sc-dVraiA jRvBse 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-fvoJAe fXDUkc stock-movers-container default"><div class="header-container"><div class="sc-iiqfCt kvSldG styled-line"></div><h2>Stock Movers</h2><div class="sc-iiqfCt kvSldG styled-line"></div></div><div class="stock-movers-table-container full-width-table flex" id="full-width-movers-table"><div><header class="sc-eAQwYs eyWkLM 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-bWtsZH dczzGV 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-eAQwYs jQnOJj 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-bWtsZH dczzGV 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-hHEtgg jkpSxH block"><div class="sc-cAgXCv faGBSq faq-container"><div class="sc-fZcocS kEIiVN faq-block"><div class="sc-ldxRAc dUmRRP 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-ldxRAc dUmRRP 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-ldxRAc dUmRRP 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 class="layout-sidebar-sticky-box"><div class="sc-hSWyVn brajqy 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-hTgaWy jNoPDg 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 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Reserved</div></div></div></div><script id="__NEXT_DATA__" type="application/json">{"props":{"pageProps":{"calendarDataSet":[{"commentary":"","companies":[{"cik":"1693011","id":"603cef7fb9e30d0001890185","name":"Inozyme Pharma Inc","securities":[{"exchange":"NASDAQ","symbol":"INZY"}]}],"created":1740146206,"date":"2025-02-21","drug":{"generic":false,"id":"60f8061e48f06700014e16b8","indication_symptom":["ABCC6 Deficiency"],"name":"INZ-701"},"event_type":"Data Presentation","id":"67b8861eb1c67f0001388a08","nic_number":"","notes":"","outcome":"Inozyme Pharma, Inc. announced that Kurt Gunter, M.D., Senior Vice President and Chief Medical Officer, will present recently announced data from the company's Expanded Access Program (EAP) evaluating INZ-701 in infants and children with ENPP1 Deficiency at the CHOP Cardiology Annual Meeting, held February 19-23, 2025, in Orlando, 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kallikrein-1 for treating acute ischemic stroke and preventing recurrence (Kasner, et al.) which is now available online and is scheduled for print publication in the February 2025 issue of Stroke.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43846390/diamedica-therapeutics-announces-publication-of-dm199s-mechanism-of-action-for-the-treatment-of-ac","source_type":"Press Release","status":"","target_date":"","time":"08:17:04","updated":1740057463},{"commentary":"","companies":[{"cik":"1426800","id":"603cef7cb9e30d000188eac8","name":"Assembly Biosciences Inc","securities":[{"exchange":"NASDAQ","symbol":"ASMB"}]}],"created":1740057263,"date":"2025-02-20","drug":{"generic":false,"id":"67b5d6d1dcc94e0001195708","indication_symptom":["For Recurrent Genital Herpes"],"name":"ABI-1179"},"event_type":"Positive Results","id":"67b72aafb1c67f0001383456","nic_number":"","notes":"","outcome":"Assembly Biosciences, Inc announced positive interim Phase 1a results in healthy participants from its ongoing Phase 1a/b study of ABI-1179, an investigational long-acting herpes simplex virus (HSV) helicase-primase inhibitor candidate for recurrent genital herpes.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43845782/assembly-biosciences-reports-positive-interim-phase-1a-results-from-clinical-trial-evaluating-long","source_type":"Press Release","status":"Phase 1a","target_date":"","time":"08:14:23","updated":1740057384},{"commentary":"","companies":[{"cik":"725363","id":"603cef78b9e30d000188b722","name":"CEL-SCI Corp","securities":[{"exchange":"AMEX","symbol":"CVM"}]}],"created":1740057171,"date":"2025-02-20","drug":{"generic":false,"id":"60dc70dd74f1490001e1d7c0","indication_symptom":["Head and Neck Cancer"],"name":"Multikine"},"event_type":"Provided Update","id":"67b72a53b1c67f0001383434","nic_number":"","notes":"","outcome":"CEL-SCI Corporation announced it is in the final stages for the launch of its 212-patient 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year data from the Phase 2 open-label extension (OLE) study of donidalorsen, the company's investigational RNA-targeted prophylactic medicine for hereditary angioedema (HAE).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43843754/new-positive-donidalorsen-data-to-be-presented-at-aaaaiwao-joint-congress-highlight-sustained-hae-","source_type":"Press Release","status":"Phase 3","target_date":"","time":"07:12:17","updated":1740053589},{"commentary":"","companies":[{"cik":"","id":"65804e1dde13e400018dc318","name":"Unicycive Therapeutics, Inc","securities":[]}],"created":1740053469,"date":"2025-02-20","drug":{"generic":false,"id":"65804de03d5b9b0001c0a24f","indication_symptom":["In Patients with Chronic Kidney Disease on Dialysis"],"name":"Oxylanthanum Carbonate"},"event_type":"Data Publication","id":"67b71bddb1c67f00013831b5","nic_number":"","notes":"","outcome":"Unicycive Therapeutics, announced the publication of preclinical data describing the benefits of combination treatment of oxylanthanum carbonate (OLC) and tenapanor on phosphate management in the American Society of Nephrology (ASN) journal, Kidney360.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43843748/unicycive-therapeutics-announces-the-publication-of-preclinical-data-on-synergies-between-oxylanth","source_type":"Press Release","status":"","target_date":"","time":"07:11:09","updated":1740053510},{"commentary":"","companies":[{"cik":"1585608","id":"603cef7db9e30d000188f588","name":"Jaguar Health Inc","securities":[{"exchange":"NASDAQ","symbol":"JAGX"}]}],"created":1739974184,"date":"2025-02-19","drug":{"generic":false,"id":"63054e00e4a8c5000194ce26","indication_symptom":["Microvillus inclusion disease (MVID) - Rare congenital diarrheal disorder"],"name":"Crofelemer"},"event_type":"Provided Update","id":"67b5e628dcc94e0001195ac9","nic_number":"","notes":"","outcome":"Jaguar Health, announced that the clinical protocol for Napo's Phase 2 study to evaluate the efficacy of crofelemer, Jaguar's novel plant-based anti-secretory prescription drug, for the indication of SBS-IF in adults has received regulatory clearance from health authorities in Italy and Germany, where the trial will be conducted.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/ac43812310/jaguar-receives-regulatory-clearance-in-germany-and-italy-for-crofelemer-for-rare-disease-study-s","source_type":"Press Release","status":"Phase 2","target_date":"","time":"09:09:44","updated":1739974301},{"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":1739973111,"date":"2025-02-19","drug":{"generic":false,"id":"60468aafe74cfd00012cae05","indication_symptom":["Chronic Venous Insufficiency 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The presentation is scheduled for today at 9:47 AM ET.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/ac43811597/one-year-data-from-the-venovalve-r-u-s-pivotal-trial-highlighting-impact-on-patients-quality-of-l","source_type":"Press Release","status":"","target_date":"","time":"08:51:51","updated":1739973165},{"commentary":"","companies":[{"cik":"","id":"65310876c697190001dd8b9c","name":"IMUNON Inc","securities":[]}],"created":1739971594,"date":"2025-02-19","drug":{"generic":false,"id":"64c0cdbc9c212e0001522246","indication_symptom":["For ovarian cancer"],"name":"IMNN-001"},"event_type":"New Data","id":"67b5dc0adcc94e00011958bf","nic_number":"","notes":"","outcome":"IMUNON, Inc. announced new translational data from ongoing analyses of results from the Company's Phase 2 OVATION 2 Study of IMNN-001, its investigational interleukin-12 (IL-12) immunotherapy based on the company's proprietary TheraPlas® technology, for the treatment of newly diagnosed advanced ovarian cancer.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43810387/imunon-announces-translational-data-from-phase-12-ovation-2-study-of-imnn-001-in-advanced-ovarian-","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:26:34","updated":1739971657},{"commentary":"","companies":[{"cik":"1802665","id":"603cef7fb9e30d00018901c6","name":"Harmony Biosciences Holdings Inc","securities":[{"exchange":"NASDAQ","symbol":"HRMY"}]}],"created":1739971504,"date":"2025-02-19","drug":{"generic":false,"id":"651d470208e89000019cfd58","indication_symptom":["For the treatment of excessive daytime sleepiness "],"name":"pitolisant"},"event_type":"Regulatory Update","id":"67b5dbb0dcc94e0001195896","nic_number":"","notes":"","outcome":"Harmony Biosciences Holdings, Inc announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43810390/harmony-biosciences-provides-update-on-the-status-of-the-supplemental-new-drug-application-for-pit","source_type":"Press Release","status":"Refusal to File (RTF)","target_date":"","time":"08:25:04","updated":1739971584},{"commentary":"","companies":[{"cik":"1408443","id":"603cef7eb9e30d000188fedb","name":"Milestone Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"MIST"}]}],"created":1739971441,"date":"2025-02-19","drug":{"generic":false,"id":"66040ef0cad84c00018292ad","indication_symptom":["For Treatment in Paroxysmal Supraventricular Tachycardia"],"name":"Etripamil"},"event_type":"Provided Update","id":"67b5db71dcc94e0001195877","nic_number":"","notes":"","outcome":"Milestone® Pharmaceuticals Inc. announced that it has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) on a new Method of Use patent for etripamil nasal spray (proposed trade name CARDAMYST™), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43810105/milestone-pharmaceuticals-notice-of-allowance-on-new-u-s-patent-for-etripamil","source_type":"Press Release","status":"","target_date":"","time":"08:24:01","updated":1739971481},{"commentary":"","companies":[{"cik":"","id":"655206cab3615100015df128","name":"Sagimet Biosciences Inc","securities":[]}],"created":1739971332,"date":"2025-02-19","drug":{"generic":false,"id":"65520a5f207b9d0001912b8d","indication_symptom":["For Liver Diseases"],"name":"denifanstat"},"event_type":"Presentation","id":"67b5db04dcc94e0001195862","nic_number":"","notes":"","outcome":"Sagimet Biosciences Inc. announced that an oral presentation on denifanstat's effect on triglycerides and LDL-cholesterol in advanced fibrosis patients will be delivered at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium being held February 23-26, 2025 in Banff, Canada.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43810165/sagimet-biosciences-announces-oral-presentation-at-the-mash-pathogenesis-and-therapeutic-approache","source_type":"Press Release","status":"Phase 2b","target_date":"","time":"08:22:12","updated":1739971413},{"commentary":"","companies":[{"cik":"","id":"6628d138ed9ebb000172cc47","name":"Alto Neuroscience Inc","securities":[]}],"created":1739971256,"date":"2025-02-19","drug":{"generic":false,"id":"675842ecaed0910001a272b2","indication_symptom":["adjunctive treatment in MDD"],"name":"ALTO-300"},"event_type":"Provided Update","id":"67b5dab8dcc94e0001195842","nic_number":"","notes":"","outcome":"Alto Neuroscience, Inc announced that the U.S. Patent and Trademark Office has granted U.S. Patent Number 12,226,375, with method claims pertaining to treatment of major depressive disorder (MDD) in patients with inadequate response to an antidepressant.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43810336/alto-neuroscience-announces-u-s-patent-granted-covering-alto-300-as-a-treatment-for-patients-with-","source_type":"Press Release","status":"","target_date":"","time":"08:20:56","updated":1739971297},{"commentary":"","companies":[{"cik":"1638097","id":"603cef7eb9e30d000188fbbb","name":"Entera Bio Ltd","securities":[{"exchange":"NASDAQ","symbol":"ENTX"}]}],"created":1739971178,"date":"2025-02-19","drug":{"generic":false,"id":"604a31833c2ff90001957721","indication_symptom":["Parathyroid hormone (1-34)"," or PTH for osteoporosis"],"name":"EB613"},"event_type":"Presentation","id":"67b5da6adcc94e0001195824","nic_number":"","notes":"","outcome":"Entera Bio Ltd. announced that the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) Scientific Programme Committee has accepted both submitted abstracts 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(PSC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43808690/chemomab-completes-successful-end-of-phase-2-meeting-and-aligns-with-fda-on-clear-and-efficient-pa","source_type":"Press Release","status":"Phase 3","target_date":"","time":"07:15:26","updated":1739967443},{"commentary":"","companies":[{"cik":"1070081","id":"603cef7db9e30d000188f28a","name":"PTC Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"PTCT"}]}],"created":1739966802,"date":"2025-02-19","drug":{"generic":false,"id":"6091e85e2bc27400010a514a","indication_symptom":["Friedreich ataxia"],"name":"Vatiquinone (MOVE-FA)"},"event_type":"FDA Accepted","id":"67b5c9522b94b70001f990f3","nic_number":"","notes":"","outcome":"PTC Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for vatiquinone for the treatment of children and adults living with Friedreich's ataxia (FA).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43808727/ptc-therapeutics-announces-fda-acceptance-and-priority-review-for-vatiquinone-nda-for-the-treatmen","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"","time":"07:06:42","updated":1739966922},{"commentary":"","companies":[{"cik":"1070081","id":"603cef7db9e30d000188f28a","name":"PTC Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"PTCT"}]}],"created":1739966855,"date":"2025-02-19","drug":{"generic":false,"id":"6091e85e2bc27400010a514a","indication_symptom":["Friedreich ataxia"],"name":"Vatiquinone (MOVE-FA)"},"event_type":"PDUFA Date","id":"67b5c9872b94b70001f99103","nic_number":"","notes":"","outcome":"PTC Therapeutics, Inc. announced that PDUFA target action date of Aug. 19, 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survival (OS) from the Phase 3 CheckMate -816 study, which evaluated Opdivo® (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43808682/bristol-myers-squibb-announces-opdivo-plus-chemotherapy-as-the-first-and-only-neoadjuvant-only-imm","source_type":"Press Release","status":"Phase 3","target_date":"","time":"07:02:02","updated":1739966578},{"commentary":"","companies":[{"cik":"1129928","id":"603cef79b9e30d000188c10f","name":"Oncolytics Biotech Inc","securities":[{"exchange":"NASDAQ","symbol":"ONCY"}]}],"created":1739934878,"date":"2025-02-18","drug":{"generic":false,"id":"6616450e84104e0001863ddf","indication_symptom":["In Breast Cancer"],"name":"Pelareorep"},"event_type":"Provided 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During the conference call, Eric Hughes, MD, PhD, Executive Vice President of Global R\u0026D and Chief Medical Officer, and external IBD key opinion leaders (KOLs) will discuss new data presented for duvakitug (anti-TL1A) positive Phase 2b results at the 20th Annual Congress of the European Crohn's and Colitis Organization (ECCO).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43798285/teva-to-host-conference-call-on-february-24-2025-to-discuss-new-data-presented-for-duvakitug-anti-","source_type":"Press Release","status":"","target_date":"","time":"21:17:51","updated":1739931527},{"commentary":"","companies":[{"cik":"1356576","id":"603cef7db9e30d000188ec96","name":"Supernus Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"SUPN"}]}],"created":1739931358,"date":"2025-02-18","drug":{"generic":false,"id":"610b0e18b4035700018a096b","indication_symptom":["Resistant depression"],"name":"SPN-820"},"event_type":"Provided 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treatment of Dravet syndrome, in all territories outside the United States, Canada, and Mexico.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43778917/biogen-and-stoke-therapeutics-enter-into-collaboration-to-develop-and-commercialize-zorevunersen-f","source_type":"Press Release","status":"","target_date":"","time":"08:13:19","updated":1739884465},{"commentary":"","companies":[{"cik":"","id":"67b486addcc94e0001190ccc","name":"Septerna Inc","securities":[{"exchange":"NASDAQ","symbol":"SEPN"}]}],"created":1739884169,"date":"2025-02-18","drug":{"generic":false,"id":"67b456a4b156400001be76e4","indication_symptom":[" PTH1R Agonist"],"name":"SEP-786"},"event_type":"Provided Update","id":"67b48689dcc94e0001190cc0","nic_number":"","notes":"","outcome":"Septerna, announced its decision to discontinue the Phase 1 single- and multiple-ascending dose (SAD/MAD) clinical trial of SEP-786 in healthy volunteers.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43778828/septerna-announces-discontinuation-of-sep-786-phase-1-clinical-trial-and-plans-to-advance-next-gen","source_type":"Press Release","status":"","target_date":"","time":"08:09:29","updated":1739884329},{"commentary":"","companies":[{"cik":"1651311","id":"603cef7eb9e30d000188f7ed","name":"Merus NV","securities":[{"exchange":"NASDAQ","symbol":"MRUS"}]}],"created":1739884088,"date":"2025-02-18","drug":{"generic":false,"id":"6642071fa3202c0001ae8c36","indication_symptom":["For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)"],"name":"petosemtamab"},"event_type":"Designation Grant","id":"67b48638dcc94e0001190c9b","nic_number":"","notes":"","outcome":"Merus N.V announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adult patients with recurrent or metastatic programmed death-ligand 1 (PD-L1) positive head and neck squamous cell carcinoma (r/m HNSCC) with combined positive score (CPS) ≥ 1.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43778779/petosemtamab-granted-breakthrough-therapy-designation-by-the-u-s-fda-for-1l-pd-l1-positive-head-an","source_type":"Press Release","status":"Breakthrough Therapy Designation","target_date":"","time":"08:08:08","updated":1739884149},{"commentary":"","companies":[{"cik":"1062822","id":"603cef78b9e30d000188b91c","name":"Lexicon Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"LXRX"}]}],"created":1739884023,"date":"2025-02-18","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). "],"name":"sotagliflozin"},"event_type":"Publication","id":"67b485f7dcc94e0001190c6f","nic_number":"","notes":"","outcome":"Lexicon Pharmaceuticals, Inc announced The Lancet Diabetes \u0026 Endocrinology has published a research paper analyzing the ability of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to reduce the risks of life-threatening cardiovascular outcomes.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43778780/published-data-in-the-lancet-diabetes-endocrinology-highlights-unique-efficacy-benefits-of-sotagli","source_type":"Press Release","status":"","target_date":"","time":"08:07:03","updated":1739884067},{"commentary":"","companies":[{"cik":"","id":"65200c923b3e38000193adc8","name":"ARS Pharmaceuticals Inc","securities":[]}],"created":1739882550,"date":"2025-02-18","drug":{"generic":false,"id":"66dfe71e6d02590001c90a27","indication_symptom":[" For Pediatric Patients with Type I Allergic 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Update","id":"67b47f56dcc94e0001190b05","nic_number":"","notes":"","outcome":"Opus Genetics, Inc. announced that the first pediatric patient was dosed in its ongoing Phase 1/2 clinical trial evaluating OPGx-LCA5, its investigational gene therapy for the treatment of Leber congenital amaurosis (LCA).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43778028/opus-genetics-announces-updates-on-opgx-lca5-clinical-program","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"07:38:46","updated":1739882398},{"commentary":"","companies":[{"cik":"1228627","id":"603cef7fb9e30d0001890310","name":"Ocuphire Pharma Inc","securities":[{"exchange":"NASDAQ","symbol":"OCUP"}]}],"created":1739882352,"date":"2025-02-18","drug":{"generic":false,"id":"6717a3e41e18f9000110b3e4","indication_symptom":["For LCA5"],"name":"OPGx-LCA5"},"event_type":"Initial Data","id":"67b47f70dcc94e0001190b11","nic_number":"","notes":"","outcome":"Opus plans to share initial data from the pediatric cohort by Q3 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43778028/opus-genetics-announces-updates-on-opgx-lca5-clinical-program","source_type":"Press Release","status":"","target_date":"2025-Q3","time":"07:39:12","updated":1739882397},{"commentary":"","companies":[{"cik":"1001316","id":"603cef78b9e30d000188b961","name":"TG Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"TGTX"}]}],"created":1739882246,"date":"2025-02-18","drug":{"generic":false,"id":"6493ecad08348c00019bdf5f","indication_symptom":[" For the management of autoimmune disorders"],"name":"BRIUMVI"},"event_type":"Presentation","id":"67b47f06dcc94e0001190af3","nic_number":"","notes":"","outcome":"TG Therapeutics, Inc. announced the schedule of presentations highlighting data from the ULTIMATE I \u0026 II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS) to be presented at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 27 – March 1, 2025, in West Palm Beach, Florida.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43778015/tg-therapeutics-announces-schedule-of-data-presentations-for-briumvi-ublituximab-in-multiple-scler","source_type":"Press Release","status":"Phase 3","target_date":"","time":"07:37:26","updated":1739882313},{"commentary":"","companies":[{"cik":"1087294","id":"603cef7ab9e30d000188d416","name":"Cumberland Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"CPIX"}]}],"created":1739882171,"date":"2025-02-18","drug":{"generic":false,"id":"651d470508e89000019cfd78","indication_symptom":["FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) "],"name":"Vibativ"},"event_type":"Approved","id":"67b47ebbdcc94e0001190ade","nic_number":"","notes":"","outcome":"Cumberland Pharmaceuticals Inc and SciClone Pharmaceuticals (Holdings) Limited announced the NMPA (National Medical Products Administration) approval of Cumberland's Vibativ® (telavancin) injection in China.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43778030/vibativ-receives-marketing-approval-in-china","source_type":"Press Release","status":"","target_date":"","time":"07:36:11","updated":1739882234},{"commentary":"","companies":[{"cik":"1707502","id":"603cef7eb9e30d000188fc03","name":"Solid Biosciences Inc","securities":[{"exchange":"NASDAQ","symbol":"SLDB"}]}],"created":1739881704,"date":"2025-02-18","drug":{"generic":false,"id":"6553ed6282104a0001e65532","indication_symptom":["For Duchenne Muscular Dystrophy Gene Therapy"],"name":"SGT-003"},"event_type":"Positive Data","id":"67b47ce8dcc94e0001190aab","nic_number":"","notes":"","outcome":"Solid Biosciences announced positive initial data from the Phase 1/2 INSPIRE DUCHENNE trial evaluating SGT-003, a next-generation gene therapy product candidate intended for the treatment of Duchenne muscular dystrophy (Duchenne).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43776501/solid-biosciences-reports-positive-initial-clinical-data-from-next-generation-duchenne-gene-therap","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"07:28:24","updated":1739881761},{"commentary":"","companies":[{"cik":"","id":"67163c81d5a7650001307f36","name":"Elevai Biosciences Inc","securities":[{"exchange":"NASDAQ","symbol":"ELAB"}]}],"created":1739881564,"date":"2025-02-18","drug":{"generic":false,"id":"6717a3e51e18f9000110b3ea","indication_symptom":["In the treatment of obesity and muscle loss preservation."],"name":"EL-22"},"event_type":"Pre-IND 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meeting with the FDA in the second fiscal quarter of 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43776940/northstrive-biosciences-inc-a-subsidiary-of-pmgc-holdings-inc-announces-successful-submission-of-p","source_type":"Press Release","status":"Type B Meeting","target_date":"2025-Q2","time":"07:26:46","updated":1739881658},{"commentary":"","companies":[{"cik":"1117480","id":"603cef7db9e30d000188f22e","name":"Chimerix Inc","securities":[{"exchange":"NASDAQ","symbol":"CMRX"}]}],"created":1739881441,"date":"2025-02-18","drug":{"generic":false,"id":"6756db23f5ad71000149f304","indication_symptom":["treatment for recurrent H3 K27M-mutant diffuse glioma "],"name":"dordaviprone"},"event_type":"FDA Accepted","id":"67b47be1dcc94e0001190a5d","nic_number":"","notes":"","outcome":"Chimerix announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43776943/chimerix-announces-fda-acceptance-and-priority-review-of-new-drug-application-for-dordaviprone-as-","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"","time":"07:24:01","updated":1739881545},{"commentary":"","companies":[{"cik":"1117480","id":"603cef7db9e30d000188f22e","name":"Chimerix Inc","securities":[{"exchange":"NASDAQ","symbol":"CMRX"}]}],"created":1739881481,"date":"2025-02-18","drug":{"generic":false,"id":"6756db23f5ad71000149f304","indication_symptom":["treatment for recurrent H3 K27M-mutant diffuse glioma "],"name":"dordaviprone"},"event_type":"PDUFA Date","id":"67b47c09dcc94e0001190a6a","nic_number":"","notes":"","outcome":"Chimerix announced that PDUFA Target Action Date of August 18, 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(COAST) or ranibizumab (ShORe), compared to standard of care alone for the treatment of wet AMD.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43776880/opthea-completes-coast-final-week-52-patient-visit","source_type":"Press Release","status":"","target_date":"","time":"07:22:13","updated":1739881422},{"commentary":"","companies":[{"cik":"1815620","id":"603cef7ab9e30d000188cfac","name":"Opthea Ltd","securities":[{"exchange":"GREY","symbol":"CKDXF"},{"exchange":"NASDAQ","symbol":"OPT"}]}],"created":1739881356,"date":"2025-02-18","drug":{"generic":false,"id":"6655d2d63b127300013915c8","indication_symptom":["In Wet AMD"],"name":"sozinibercept"},"event_type":"Results","id":"67b47b8cdcc94e0001190a41","nic_number":"","notes":"","outcome":"Opthea Limited announced that The topline results from both trials are anticipated in early Q2 CY25 (COAST) and mid-CY25 (ShORe).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43776880/opthea-completes-coast-final-week-52-patient-visit","source_type":"Press Release","status":"","target_date":"2025-Q2","time":"07:22:36","updated":1739881421},{"commentary":"","companies":[{"cik":"1759138","id":"603cef7eb9e30d000188ffed","name":"Cabaletta Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"CABA"}]}],"created":1739881026,"date":"2025-02-18","drug":{"generic":false,"id":"6548de99caf68a0001072ba8","indication_symptom":["For Treatment of Generalized Myasthenia Gravis"],"name":"CABA-201"},"event_type":"New Data","id":"67b47a42dcc94e00011909fe","nic_number":"","notes":"","outcome":"Cabaletta Bio, Inc. announced new and updated clinical data from the first 10 patients dosed with resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) across the RESET clinical development program.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43776901/cabaletta-bio-announces-updated-clinical-data-demonstrating-deepening-clinical-responses-across-mu","source_type":"Press Release","status":"","target_date":"","time":"07:17:06","updated":1739881200},{"commentary":"","companies":[{"cik":"1614744","id":"603cef7db9e30d000188eca2","name":"Purple Biotech Ltd","securities":[{"exchange":"NASDAQ","symbol":"PPBT"}]}],"created":1739880823,"date":"2025-02-18","drug":{"generic":false,"id":"60a65c3d674f65000188a2ae","indication_symptom":["Adults with Advanced Solid Tumors and Head and Neck Cancer"],"name":"NT219"},"event_type":"Provided Update","id":"67b47977dcc94e00011909de","nic_number":"","notes":"","outcome":"Purple Biotech Ltd. announced it is advancing into a Phase 2 study with NT219 in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).","outcome_brief":"","source_link":"https://www.globenewswire.com/news-release/2025/02/18/3027637/0/en/Purple-Biotech-Advances-NT219-into-Phase-2-Head-and-Neck-Cancer-Trial.html","source_type":"Other","status":"Phase 2","target_date":"","time":"07:13:43","updated":1739880967},{"commentary":"","companies":[{"cik":"","id":"6527c12b7f1949000153cd6d","name":"Alvotech","securities":[]},{"cik":"872589","id":"603cef78b9e30d000188ba95","name":"Regeneron Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"REGN"}]}],"created":1739878144,"date":"2025-02-18","drug":{"generic":false,"id":"612505bfb4035700018c2073","indication_symptom":["Wet age-related macular degeneration (wet AMD)"],"name":"EYLEA (aflibercept)"},"event_type":"FDA Accepted","id":"67b46f00dcc94e0001190727","nic_number":"","notes":"","outcome":"Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept), a biologic used to treat eye disorders, including diseases which can lead to vision loss or blindness.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43775568/alvotech-and-teva-announce-filing-acceptance-of-u-s-biologics-license-application-for-avt06-a-prop","source_type":"Press Release","status":"Biologics License Applications (BLA)","target_date":"","time":"06:29:04","updated":1739878275},{"commentary":"","companies":[{"cik":"","id":"6527c12b7f1949000153cd6d","name":"Alvotech","securities":[]},{"cik":"872589","id":"603cef78b9e30d000188ba95","name":"Regeneron Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"REGN"}]}],"created":1739878201,"date":"2025-02-18","drug":{"generic":false,"id":"612505bfb4035700018c2073","indication_symptom":["Wet age-related macular degeneration (wet AMD)"],"name":"EYLEA (aflibercept)"},"event_type":"Regulatory 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SA","securities":[{"exchange":"NASDAQ","symbol":"SNY"},{"exchange":"OTC","symbol":"SNYNF"}]}],"created":1739871336,"date":"2025-02-18","drug":{"generic":false,"id":"60408ace0216d50001d0a038","indication_symptom":["Moderate-to-severe asthma"],"name":"Dupixent (dupilumab)"},"event_type":"FDA Accepted","id":"67b45468b156400001be7642","nic_number":"","notes":"","outcome":"Regeneron Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to treat adults with bullous pemphigoid (BP).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43772719/press-release-dupixent-sbla-accepted-for-fda-priority-review-for-the-targeted-treatment-of-bullous","source_type":"Press Release","status":"supplemental Biologics License Applications (sBLA)","target_date":"","time":"04:35:36","updated":1739871394},{"commentary":"","companies":[{"cik":"","id":"659443f2b02d410001314f83","name":"GSK plc","securities":[]}],"created":1739871881,"date":"2025-02-17","drug":{"generic":false,"id":"67af39cdb156400001be35a5","indication_symptom":["Help Protect Against MenABCWY"],"name":"PENMENVY"},"event_type":"FDA Approval","id":"67b45689b156400001be76e1","nic_number":"","notes":"","outcome":"GSK plc announced that the US Food and Drug Administration (FDA) has approved PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) for use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of Neisseria meningitidis (A, B, C, W, and Y) which commonly cause invasive meningococcal disease (IMD).1,2","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43769819/gsk-investor-alert-bronstein-gewirtz-grossman-llc-announces-that-gsk-plc-investors-with-substantia","source_type":"Press Release","status":"FDA Approved","target_date":"","time":"04:44:41","updated":1739872018},{"commentary":"","companies":[{"cik":"14272","id":"603cef78b9e30d000188b6a3","name":"Bristol-Myers Squibb Company","securities":[{"exchange":"NYSE","symbol":"BMY"},{"exchange":"OTC","symbol":"BMYMP"}]}],"created":1739871552,"date":"2025-02-17","drug":{"generic":false,"id":"6083004deb87ad0001ba1b2a","indication_symptom":["Moderate to severe plaque psoriasis"],"name":"Deucravacitinib"},"event_type":"Results","id":"67b45540b156400001be7677","nic_number":"","notes":"","outcome":"Bristol Myers Squibb announced new five-year results from the POETYK PSO long-term extension (LTE) trial of Sotyktu (deucravacitinib) treatment in adult patients with moderate-to-severe plaque psoriasis.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43758527/new-five-year-sotyktu-deucravacitinib-data-show-consistent-safety-and-durable-response-rates-in-mo","source_type":"Press Release","status":"","target_date":"","time":"04:39:12","updated":1739871672},{"commentary":"","companies":[{"cik":"1598599","id":"603cef7bb9e30d000188d70c","name":"Innate Pharma SA","securities":[{"exchange":"NASDAQ","symbol":"IPHA"},{"exchange":"OTC","symbol":"IPHYF"}]}],"created":1739871461,"date":"2025-02-17","drug":{"generic":false,"id":"6481b30f8dd1660001a0b25d","indication_symptom":["Treatment of patients with relapsed or refractory Sézary syndrome"],"name":"Lacutamab"},"event_type":"Designation Grant","id":"67b454e5b156400001be765a","nic_number":"","notes":"","outcome":"Innate Pharma Announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody, for the treatment of adult patients with relapsed or refractory (r/r) Sézary Syndrome (SS) after at least 2 prior systemic therapies including mogamulizumab.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43762301/innate-pharma-announces-u-s-fda-granted-breakthrough-therapy-designation-to-lacutamab-for-relapsed","source_type":"Press Release","status":"Breakthrough Therapy Designation","target_date":"","time":"04:37:41","updated":1739871558},{"commentary":"","companies":[{"cik":"939767","id":"603cef78b9e30d000188b7de","name":"Exelixis Inc","securities":[{"exchange":"NASDAQ","symbol":"EXEL"}]},{"cik":"1395064","id":"603cef7bb9e30d000188d9a3","name":"Takeda Pharmaceutical Co Ltd","securities":[{"exchange":"NYSE","symbol":"TAK"},{"exchange":"OTC","symbol":"TKPHF"}]}],"created":1739871786,"date":"2025-02-15","drug":{"generic":false,"id":"6126ab10b6abe40001ef3ddc","indication_symptom":["Unresectable or Metastatic Renal Cell Carcinoma"],"name":"CABOMETYX (cabozantinib) + OPDIVO (nivolumab)"},"event_type":"Results","id":"67b4562ab156400001be76c8","nic_number":"","notes":"","outcome":"Exelixis, Inc announced final results from the phase 3 CheckMate -9ER pivotal trial evaluating CABOMETYX® (cabozantinib) in combination with Opdivo® (nivolumab) versus sunitinib for patients with previously untreated advanced renal cell carcinoma (RCC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43756537/exelixis-announces-final-five-year-follow-up-results-from-checkmate-9er-trial-evaluating-cabometyx","source_type":"Press Release","status":"Phase 3","target_date":"","time":"04:43:06","updated":1739871847},{"commentary":"","companies":[{"cik":"901832","id":"603cef78b9e30d000188bd81","name":"AstraZeneca PLC","securities":[{"exchange":"NASDAQ","symbol":"AZN"},{"exchange":"OTC","symbol":"AZNCF"}]},{"cik":"1724521","id":"603cef7eb9e30d000188fc31","name":"Arcus Biosciences Inc","securities":[{"exchange":"NYSE","symbol":"RCUS"}]}],"created":1739871688,"date":"2025-02-15","drug":{"generic":false,"id":"66fd3beec2ed5b00011dd69a","indication_symptom":["In patients with ccRCC"],"name":"casdatifan"},"event_type":"New Data","id":"67b455c8b156400001be76a9","nic_number":"","notes":"","outcome":"Arcus Biosciences, Inc today presented new data for casdatifan, a HIF-2a inhibitor with best-in-class potential, in an oral plenary session by Dr. Toni K. Choueiri, Dana-Farber Cancer Institute, at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43757118/new-data-demonstrated-best-in-class-potential-for-casdatifan-a-hif-2a-inhibitor-in-patients-with-m","source_type":"Press Release","status":"","target_date":"","time":"04:41:28","updated":1739871768},{"commentary":"","companies":[{"cik":"1768224","id":"603cef7db9e30d000188f1ed","name":"Arcturus Therapeutics Holdings Inc","securities":[{"exchange":"NASDAQ","symbol":"ARCT"}]}],"created":1739538750,"date":"2025-02-14","drug":{"generic":false,"id":"6164a138d5cb080001d22eb1","indication_symptom":["SARS-CoV-2 Delta Variant and Other Variants of Concern"],"name":"ARCT-154"},"event_type":"Marketing authorization","id":"67af413e2b94b70001f8f7cf","nic_number":"","notes":"","outcome":"Arcturus Therapeutics announced that the European Commission has granted marketing authorization for KOSTAIVE® (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). KOSTAIVE is currently marketed in Japan against COVID-19.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43727352/european-commission-approves-csl-and-arcturus-therapeutics-kostaive-the-first-self-amplifying-mrna","source_type":"Press Release","status":"","target_date":"","time":"08:12:30","updated":1739538867},{"commentary":"","companies":[{"cik":"1808898","id":"603cef7ab9e30d000188cf81","name":"Benitec Biopharma Inc","securities":[{"exchange":"NASDAQ","symbol":"BNTC"}]}],"created":1739538665,"date":"2025-02-14","drug":{"generic":false,"id":"613918e1b6abe40001f050d6","indication_symptom":["Oculopharyngeal Muscular Dystrophy (OPMD)"],"name":"BB-301"},"event_type":"Abstract","id":"67af40e92b94b70001f8f7b4","nic_number":"","notes":"","outcome":"Benitec Biopharma Inc. announced the acceptance of a late-breaking oral abstract for the BB-301 Phase 1b/2a Clinical Treatment Study ongoing in Subjects diagnosed with Oculopharyngeal Muscular Dystrophy (OPMD) with moderate dysphagia. Interim clinical study updates for the first three Subjects will be discussed in an oral presentation at the Muscular Dystrophy Association Clinical and Scientific Conference on March 19, 2025 at 1:15 pm Central Time.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43727341/benitec-biopharma-announces-acceptance-of-late-breaking-oral-abstract-for-the-bb-301-phase-1b2a-cl","source_type":"Press Release","status":"Phase 1b/2a","target_date":"","time":"08:11:05","updated":1739538729},{"commentary":"","companies":[{"cik":"","id":"664c5fb857d42200014c0522","name":"OS Therapies Inc","securities":[]}],"created":1739537037,"date":"2025-02-14","drug":{"generic":false,"id":"66a0e0e1d989140001502fc2","indication_symptom":[" In patients with HER2-expressing solid tumors in breast cancer and other cancers"],"name":"OST-HER2"},"event_type":"Provided Update","id":"67af3a8db1c67f0001374513","nic_number":"","notes":"","outcome":"OS Therapies, Inc. announced that it has entered into agreements for the commercial manufacture of OST-HER2","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43726521/os-therapies-initiates-commercial-ready-manufacturing-of-ost-her2-to-support-anticipated-biologics","source_type":"Press Release","status":"","target_date":"","time":"07:43:57","updated":1739537090},{"commentary":"","companies":[{"cik":"","id":"67af39fcb156400001be35b5","name":"Medicus Pharma Ltd","securities":[{"exchange":"NASDAQ","symbol":"MDCX"}]}],"created":1739536820,"date":"2025-02-14","drug":{"generic":false,"id":"67af39cdb156400001be35a9","indication_symptom":["For the Treatment of Nodular Basal Cell Carcinoma"],"name":"SKNJCT-003"},"event_type":"Provided Update","id":"67af39b4b156400001be359e","nic_number":"","notes":"","outcome":"Medicus Pharma Ltd. announce that its phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States, has now randomized more than 50% of the 60 patients expected to be enrolled in the study.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43726369/medicus-pharma-provides-update-on-sknjct-003-phase-2-clinical-study-for-the-treatment-of-nodular-b","source_type":"Press Release","status":"Phase 2","target_date":"","time":"07:40:20","updated":1739537026},{"commentary":"","companies":[{"cik":"1187953","id":"603cef7cb9e30d000188e6e8","name":"Creative Medical Technology Holdings Inc","securities":[{"exchange":"OTC","symbol":"CELZ"}]}],"created":1739536069,"date":"2025-02-14","drug":{"generic":false,"id":"67abc343dcc94e0001182714","indication_symptom":["For the treatment of chronic lower back pain."],"name":"AlloStem"},"event_type":"Provided Update","id":"67af36c5b156400001be353d","nic_number":"","notes":"","outcome":"Creative Medical Technology Holdings, Inc. announced compelling mid-term follow-up data from its StemSpine® pilot study utilizing its AlloStem™ cells for the treatment of chronic lower back pain.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43725536/creative-medical-technology-holdings-announces-mid-term-follow-up-study-data-reporting-significant","source_type":"Press Release","status":"","target_date":"","time":"07:27:49","updated":1739536191},{"commentary":"","companies":[{"cik":"1512717","id":"603cef79b9e30d000188ca29","name":"Theratechnologies Inc","securities":[{"exchange":"TSE","symbol":"TH"},{"exchange":"NASDAQ","symbol":"THTX"}]}],"created":1739529858,"date":"2025-02-13","drug":{"generic":false,"id":"65afb1fded39a30001463e5e","indication_symptom":["For the reduction of excess abdominal fat in adults with HIV who have lipodystrophy."],"name":"Tesamorelin"},"event_type":"Provided Update","id":"67af1e82b1c67f00013742ec","nic_number":"","notes":"","outcome":"Theratechnologies Inc. announced that it has resumed distribution of EGRIFTA SV® (tesamorelin for injection), following correspondence from the U.S. Food and Drug Administration (FDA) that allows the Company to release two recently manufactured batches of EGRIFTA SV®.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43717960/theratechnologies-resumes-distribution-of-egrifta-sv","source_type":"Press Release","status":"","target_date":"","time":"05:44:18","updated":1739536077},{"commentary":"","companies":[{"cik":"1345099","id":"603cef7ab9e30d000188d03d","name":"Mesoblast Ltd","securities":[{"exchange":"OTC","symbol":"MEOBF"},{"exchange":"NASDAQ","symbol":"MESO"}]}],"created":1739529690,"date":"2025-02-13","drug":{"generic":false,"id":"650c1e618345120001a3d0eb","indication_symptom":[" For the treatment of severe and life-threatening inflammatory conditions. "],"name":"RYONCIL"},"event_type":"Provided Update","id":"67af1ddab1c67f00013742bc","nic_number":"","notes":"","outcome":"Mesoblast Limited announced that its recently approved product Ryoncil® (remestemcel-L) is being highlighted at the 2025 Transplantation \u0026 Cellular Therapy Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR), the industry's premier conference taking place this week in Honolulu, HI.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43717138/ryoncil-fda-approval-and-market-launch-highlighted-at-tandem-transplantation-meetings","source_type":"Press Release","status":"","target_date":"","time":"05:41:30","updated":1739529767},{"commentary":"","companies":[{"cik":"14272","id":"603cef78b9e30d000188b6a3","name":"Bristol-Myers Squibb 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Oncology.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43713543/allogene-therapeutics-announces-publication-of-durable-response-data-from-phase-1-alphaalpha2-tria","source_type":"Press Release","status":"Phase 1","target_date":"","time":"16:52:56","updated":1739483646},{"commentary":"","companies":[{"cik":"","id":"60589bcc36622a00016516f8","name":"Virpax Pharmaceuticals, Inc.","securities":[]}],"created":1739480930,"date":"2025-02-13","drug":{"generic":false,"id":"6058bbe136622a0001789621","indication_symptom":["Liposomal (Hydro) Gel Technology for postoperative pain management"],"name":"Probudur"},"event_type":"Provided Update","id":"67ae5f622b94b70001f8ed12","nic_number":"","notes":"","outcome":"Virpax Pharmaceuticals, Inc announced the completion of the full study that followed the initial Probudur™ pilot study performed by the U.S. Army Institute of Surgical Research (USAISR) under an existing Cooperative Research and Development Agreement (CRADA).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43711650/virpax-confirms-positive-results-with-us-army-with-probudur-for-combat-care-study","source_type":"Press Release","status":"","target_date":"","time":"16:08:50","updated":1739480973},{"commentary":"","companies":[{"cik":"1570562","id":"603cef7eb9e30d000188fc0d","name":"Evolus Inc","securities":[{"exchange":"NASDAQ","symbol":"EOLS"}]}],"created":1739480827,"date":"2025-02-13","drug":{"generic":false,"id":"664b3fa9b932e6000172873a","indication_symptom":["Evolus dermal filler",""],"name":"Evolysse™"},"event_type":"FDA Approval","id":"67ae5efb2b94b70001f8ecbd","nic_number":"","notes":"","outcome":"Evolus, Inc announced that the U.S. Food and Drug Administration (FDA) has approved Evolysse™ Form and Evolysse™ Smooth injectable hyaluronic acid (HA) gels, the first two products in the Evolysse™ collection.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43706265/evolus-announces-fda-approval-of-evolysse-form-and-evolysse-smooth-injectable-hyaluronic-acid-gels","source_type":"Press Release","status":"FDA Approved","target_date":"","time":"16:07:07","updated":1739480880},{"commentary":"","companies":[{"cik":"1133818","id":"603cef7cb9e30d000188e0ea","name":"Bio-Path Holdings Inc","securities":[{"exchange":"NASDAQ","symbol":"BPTH"}]}],"created":1739456870,"date":"2025-02-13","drug":{"generic":false,"id":"66c48d64cf36400001781049","indication_symptom":["Treatment for Advanced Solid Tumors"],"name":"BP1001-A"},"event_type":"Provided Update","id":"67ae0166dcc94e0001187f0a","nic_number":"","notes":"","outcome":"Bio-Path Holdings, Inc provides an update from the Company's ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the Company's ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43690774/bio-path-holdings-provides-key-clinical-updates","source_type":"Press Release","status":"Phase 1/1b","target_date":"","time":"09:27:50","updated":1739457009},{"commentary":"","companies":[{"cik":"200406","id":"603cef79b9e30d000188c04b","name":"Johnson \u0026 Johnson","securities":[{"exchange":"NYSE","symbol":"JNJ"}]}],"created":1739456580,"date":"2025-02-13","drug":{"generic":false,"id":"64998c331d538a0001e65472","indication_symptom":["Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN"],"name":"Nipocalimab"},"event_type":"Data Publication","id":"67ae0044dcc94e0001187efa","nic_number":"","notes":"","outcome":"Johnson \u0026 Johnson announced the publication of data detailing the differentiated molecular properties of nipocalimab, an investigational neonatal Fc receptor (FcRn) blocker, in mAbs.a","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43691284/new-nipocalimab-data-published-in-mabs-journal-details-differentiated-molecular-design-clinical-pr","source_type":"Press Release","status":"","target_date":"","time":"09:23:00","updated":1739456629},{"commentary":"","companies":[{"cik":"","id":"613758f9b4035700018d2836","name":"RenovoRx, Inc.","securities":[{"exchange":"NASDAQ","symbol":"RNXT"}]}],"created":1739456192,"date":"2025-02-13","drug":{"generic":false,"id":"613758c4b4035700018d2824","indication_symptom":["Solid Tumors"],"name":"RenovoCath"},"event_type":"Preclinical Data","id":"67adfec0b1c67f000136f4a8","nic_number":"","notes":"","outcome":"RenovoRx, Inc abstract published promising pre-clinical datafrom the use of RenovoRx's patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform, which aims to optimize local and targeted drug delivery in difficult-to-treat cancers.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43690828/renovorx-highlights-promising-pre-clinical-data-abstract-tamp-therapy-platform-offers-potential-to","source_type":"Press Release","status":"","target_date":"","time":"09:16:32","updated":1739456552},{"commentary":"","companies":[{"cik":"","id":"67adff52b1c67f000136f4ea","name":"Conduit Pharmaceuticals Inc.","securities":[{"exchange":"NASDAQ","symbol":"CDT"}]}],"created":1739456300,"date":"2025-02-13","drug":{"generic":false,"id":"67ade05edcc94e0001187b33","indication_symptom":["For Lupus Erythematosus model."],"name":"AZD1656"},"event_type":"Provided Update","id":"67adff2cb1c67f000136f4e3","nic_number":"","notes":"","outcome":"Conduit Pharmaceuticals Inc. announce an agreement with Charles River Laboratories Inc (\"Charles River\") to evaluate AZD1656 (and its derivatives) in a clinically relevant Systemic Lupus Erythematosus model.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43690749/conduit-pharmaceuticals-partners-with-charles-river-in-clinically-relevant-systemic-lupus-erythema","source_type":"Press Release","status":"","target_date":"","time":"09:18:20","updated":1739456478},{"commentary":"","companies":[{"cik":"1595248","id":"603cef7eb9e30d000188fb0d","name":"Genprex Inc","securities":[{"exchange":"NASDAQ","symbol":"GNPX"}]}],"created":1739456237,"date":"2025-02-13","drug":{"generic":false,"id":"6605e3c31d430a0001e539eb","indication_symptom":["For the NPRL2 tumor suppressor gene"],"name":"Oncoprex"},"event_type":"Provided Update","id":"67adfeedb1c67f000136f4bc","nic_number":"","notes":"","outcome":"Genprex, Inc announced that its research collaborators at a major cancer research center in Houston, Texas have published a new study in eLife titled, \"NPRL2 gene therapy induces effective antitumor immunity in KRAS/STK11 mutant anti-PD1 resistant metastatic non-small cell lung cancer (NSCLC) in a humanized mouse model.\"","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43691635/genprex-collaborators-find-nprl2-gene-therapy-using-oncoprex-delivery-system-is-a-potential-treatm","source_type":"Press Release","status":"","target_date":"","time":"09:17:17","updated":1739456279},{"commentary":"","companies":[{"cik":"1528115","id":"603cef7fb9e30d0001890183","name":"Annexon Inc","securities":[{"exchange":"NASDAQ","symbol":"ANNX"}]}],"created":1739456118,"date":"2025-02-13","drug":{"generic":false,"id":"624eec13d52f390001cec18b","indication_symptom":["Geographic Atrophy"],"name":"ANX007"},"event_type":"Presentation","id":"67adfe76b1c67f000136f477","nic_number":"","notes":"","outcome":"Annexon, Inc. announced presentations on ANX007 in geographic atrophy (GA) at the Macula Society 48th Annual Meeting being held February 12-15 in Charlotte Harbor, Florida.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43692147/annexon-announces-presentations-highlighting-anx007-functional-and-structural-differentiation-in-g","source_type":"Press Release","status":"","target_date":"","time":"09:15:18","updated":1739456165},{"commentary":"","companies":[{"cik":"925741","id":"603cef78b9e30d000188bdc5","name":"BioCardia Inc","securities":[{"exchange":"NASDAQ","symbol":"BCDA"}]}],"created":1739455970,"date":"2025-02-13","drug":{"generic":false,"id":"67abc343dcc94e0001182718","indication_symptom":["For Treat Ischemic Heart Failure of Reduced Ejection Fraction (HFrEF)"],"name":"BCDA-03"},"event_type":"Enrollment Update","id":"67adfde2b1c67f000136f427","nic_number":"","notes":"","outcome":"BioCardia, announced today completion of enrollment and dosing in the low dose cohort in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43692141/biocardia-reports-completion-of-low-dose-cohort-enrollment-for-cardiallo-phase-iii-clinical-trial-","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"09:12:50","updated":1739456083},{"commentary":"","companies":[{"cik":"","id":"6227734a26d793000121444e","name":"TC Biopharm (Holdings) PLC","securities":[{"exchange":"NASDAQ","symbol":"TCBP"}]}],"created":1739455909,"date":"2025-02-13","drug":{"generic":false,"id":"66d6ef99c2ed5b000119a615","indication_symptom":[" In patients with AML or MDS/AML"," with either refractory or relapsed disease."],"name":"TCB008"},"event_type":"Dose Update","id":"67adfda5b1c67f000136f408","nic_number":"","notes":"","outcome":"TC BioPharm announced that it has concluded dosing of Cohort A patients in the ACHIEVE Phase 2B UK clinical 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and manufacturing organization (CDMO) focused on drug-device combination products.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43688524/nutriband-and-kindeva-drug-delivery-formalize-exclusive-development-partnership-for-aversa-fentany","source_type":"Press Release","status":"","target_date":"","time":"07:06:43","updated":1739448485},{"commentary":"","companies":[{"cik":"863894","id":"603cef78b9e30d000188b803","name":"Veru Inc","securities":[{"exchange":"NASDAQ","symbol":"VERU"}]}],"created":1739446650,"date":"2025-02-13","drug":{"generic":false,"id":"609c403cf7862d0001172199","indication_symptom":["Metastatic Castration and AR Targeting Agent Resistant Prostate Cancer"],"name":"Sabizabulin (VERACITY)"},"event_type":"Provided Update","id":"67add97adcc94e0001187a18","nic_number":"","notes":"","outcome":"Veru Inc provided an update on progress of its clinical development 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response.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43687696/agios-phase-3-activate-kids-study-of-mitapivat-in-children-with-pyruvate-kinase-pk-deficiency-not-","source_type":"Press Release","status":"Phase 3","target_date":"","time":"06:35:15","updated":1739446624},{"commentary":"","companies":[{"cik":"1676725","id":"603cef7eb9e30d000188ff08","name":"IDEAYA Biosciences Inc","securities":[{"exchange":"NASDAQ","symbol":"IDYA"}]}],"created":1739444805,"date":"2025-02-13","drug":{"generic":false,"id":"6078c2a94853ea0001eb188a","indication_symptom":["Solid Tumors"],"name":"IDE397"},"event_type":"Provided Update","id":"67add245b156400001bde867","nic_number":"","notes":"","outcome":"IDEAYA Biosciences, Inc. announced it has entered into an additional clinical study collaboration and supply agreement with Gilead Sciences, Inc. (Gilead) to evaluate the efficacy and safety of IDE397, its investigational, potential first-in-class, small molecule MAT2A inhibitor, in combination with Gilead's Trodelvy® (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), in methylthioadenosine phosphorylase (MTAP)-deletion non-small cell lung cancer (NSCLC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43687015/ideaya-announces-further-gilead-sciences-clinical-study-collaboration-evaluating-combination-of-tr","source_type":"Press Release","status":"","target_date":"","time":"06:06:45","updated":1739444879},{"commentary":"","companies":[{"cik":"","id":"6537b7a40d10db0001eb3939","name":"NKGen Biotech Inc","securities":[]}],"created":1739366056,"date":"2025-02-12","drug":{"generic":false,"id":"64f6d01badd8280001ff4e92","indication_symptom":["To Treat Alzheimer's Disease"],"name":"troculeucel (SNK01)"},"event_type":"Designation 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(CAR) T-cell therapy.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43666802/u-s-fda-approves-pfizers-adcetris-combination-regimen-for-the-treatment-of-relapsedrefractory-diff","source_type":"Press Release","status":"supplemental Biologics License Applications (sBLA)","target_date":"","time":"16:00:58","updated":1739394135},{"commentary":"","companies":[{"cik":"1098972","id":"603cef78b9e30d000188bd44","name":"Agenus Inc","securities":[{"exchange":"NASDAQ","symbol":"AGEN"}]}],"created":1739393960,"date":"2025-02-12","drug":{"generic":false,"id":"6076eb612290f10001c67d85","indication_symptom":["Multiple myeloma"],"name":"AgenT-797"},"event_type":"Oral presentation","id":"67ad0ba8dcc94e0001186d87","nic_number":"","notes":"","outcome":"MiNK Therapeutics, announced that it has been selected for an oral presentation at the upcoming American Association for Cancer Research (AACR) IO Annual Meeting that will take place on February 23-26 in Los Angeles, 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INO-3107.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43654992/clinical-and-immunological-results-from-phase-12-study-of-ino-3107-as-a-treatment-for-recurrent-re","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"08:06:27","updated":1739365672},{"commentary":"","companies":[{"cik":"1372299","id":"603cef7db9e30d000188f5da","name":"Ocugen Inc","securities":[{"exchange":"NASDAQ","symbol":"OCGN"}]}],"created":1739364473,"date":"2025-02-12","drug":{"generic":false,"id":"616f90633abe8b00016aad81","indication_symptom":["Dry Age-related Macular Degeneration (Dry AMD)"],"name":"OCU410"},"event_type":"Dose Update","id":"67ac9879b1c67f000136a935","nic_number":"","notes":"","outcome":"Ocugen, Inc. announced that dosing is complete, ahead of schedule in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410—a novel multifunctional modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43654407/ocugen-inc-announces-dosing-completion-in-the-phase-2-armada-clinical-trial-for-ocu410-a-multifunc","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"07:47:53","updated":1739364526},{"commentary":"","companies":[{"cik":"1370053","id":"603cef7eb9e30d000188f7b0","name":"AnaptysBio Inc","securities":[{"exchange":"NASDAQ","symbol":"ANAB"}]}],"created":1739364378,"date":"2025-02-12","drug":{"generic":false,"id":"6192b70d3dfee90001535c80","indication_symptom":["Healthy Volunteer"],"name":"Rosnilimab (formerly ANB030)"},"event_type":"Data","id":"67ac981a2b94b70001f86b83","nic_number":"","notes":"","outcome":"AnaptysBio, Inc. announced statistically significant Week 12 data from the global 424-patient Phase 2b RENOIR trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis (RA).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43653924/anaptys-announces-rosnilimab-achieved-positive-results-in-ra-phase-2b-trial-and-highest-ever-repor","source_type":"Press Release","status":"Phase 2b","target_date":"","time":"07:46:18","updated":1739364437},{"commentary":"","companies":[{"cik":"","id":"664c5fb857d42200014c0520","name":"Biodexa Pharmaceuticals PLC","securities":[]}],"created":1739364288,"date":"2025-02-12","drug":{"generic":false,"id":"6666eea6b531ba0001990fb5","indication_symptom":["In Familial Adenomatous Polyposis "],"name":"eRapa"},"event_type":"Designation Grant","id":"67ac97c02b94b70001f86b71","nic_number":"","notes":"","outcome":"Biodexa Pharmaceuticals PLC announced that it has received Fast Track status from the U.S. Food and Drug Administration for eRapa, a proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/ac43654085/following-positive-phase-2-results-and-orphan-drug-designation-biodexas-fap-drug-receives-fda-fas","source_type":"Press Release","status":"Fast Track Designation","target_date":"","time":"07:44:48","updated":1739364346},{"commentary":"","companies":[{"cik":"882361","id":"603cef78b9e30d000188b93f","name":"Aptose Biosciences Inc","securities":[{"exchange":"TSE","symbol":"APS"},{"exchange":"NASDAQ","symbol":"APTO"}]}],"created":1739362905,"date":"2025-02-12","drug":{"generic":false,"id":"6482dc38fdfac50001750d1b","indication_symptom":["Tuspetinib is a potent inhibitor of FLT3"," SYK"," cKITMUT"," JAK"," and other kinases"],"name":"tuspetinib"},"event_type":"Results","id":"67ac9259b156400001bd95df","nic_number":"","notes":"","outcome":"Aptose Biosciences Inc today reported promising early safety and response results from newly diagnosed acute myeloid leukemia (AML) patients dosed in Aptose's Phase 1/2 TUSCANY trial with a 40 mg dose of tuspetinib in combination with standard of care dosing of venetoclax and azacitidine (TUS+VEN+AZA triplet).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43652730/aptoses-frontline-triple-drug-therapy-with-tuspetinib-achieves-notable-responses-in-newly-diagnose","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"07:21:45","updated":1739362971},{"commentary":"","companies":[{"cik":"1398733","id":"603cef7db9e30d000188ef63","name":"Aquestive Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"AQST"}]}],"created":1739362725,"date":"2025-02-12","drug":{"generic":false,"id":"65520424a54dc20001b23f87","indication_symptom":[" For epinephrine prodrug candidate product"],"name":"Anaphylm"},"event_type":"Presentation","id":"67ac91a5b156400001bd95ab","nic_number":"","notes":"","outcome":"Aquestive Therapeutics, Inc. announced that multiple presentations highlighting results from the investigational use of Anaphylm epinephrine sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43652727/aquestive-therapeutics-to-present-new-findings-on-anaphylm-epinephrine-sublingual-film-at-the-2025","source_type":"Press Release","status":"","target_date":"","time":"07:18:45","updated":1739362768},{"commentary":"","companies":[{"cik":"","id":"603cef7bb9e30d000188dea8","name":"OKYO Pharma Ltd","securities":[]}],"created":1739362657,"date":"2025-02-12","drug":{"generic":false,"id":"637b2da09f15fd0001ad91d4","indication_symptom":["Treatment of Dry Eye Disease"],"name":"OK-101"},"event_type":"Provided Update","id":"67ac9161b156400001bd9590","nic_number":"","notes":"","outcome":"OKYO Pharma is pleased to announce that its lead asset, OK-101, has been officially assigned 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and Janus kinase 3 (JAK3) in development for the treatment of autoimmune and inflammatory diseases.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43652361/new-publication-highlights-unique-properties-of-ati-2138-a-potent-and-selective-inhibitor-of-itk-a","source_type":"Press Release","status":"","target_date":"","time":"07:11:16","updated":1739362322},{"commentary":"","companies":[{"cik":"1711754","id":"603cef7eb9e30d000188fe71","name":"INmune Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"INMB"}]}],"created":1739362165,"date":"2025-02-12","drug":{"generic":false,"id":"60ec3b56e16dc10001cc4a60","indication_symptom":["High-Risk Myelodysplastic Syndrome (MDS)"],"name":"INKmune"},"event_type":"Dose Update","id":"67ac8f75b156400001bd94b9","nic_number":"","notes":"","outcome":"INmune Bio Inc. pleased to announce completion of the third and highest dose cohort of the Phase I portion of the trial allowing opening of the Phase II high dose cohort.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43652740/inmune-bio-opens-phase-ii-in-high-dose-cohort-of-inkmune-trial-in-prostate-cancer","source_type":"Press Release","status":"Phase 1","target_date":"","time":"07:09:25","updated":1739362256},{"commentary":"","companies":[{"cik":"1593984","id":"603cef7db9e30d000188f434","name":"MediWound Ltd","securities":[{"exchange":"NASDAQ","symbol":"MDWD"}]}],"created":1739362094,"date":"2025-02-12","drug":{"generic":false,"id":"605ba9a036622a0001bfe2ef","indication_symptom":["Chronic Wounds"],"name":"EscharEx"},"event_type":"Provided Update","id":"67ac8f2eb156400001bd9479","nic_number":"","notes":"","outcome":"MediWound Ltd announced that Interim analysis planned after 65% of patients complete treatment, expected in 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(VLUs).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43652725/mediwound-initiates-the-value-global-phase-iii-pivotal-trial-of-escharex-for-treatment-of-venous-l","source_type":"Press Release","status":"Phase 3","target_date":"","time":"07:07:33","updated":1739362146},{"commentary":"","companies":[{"cik":"1625297","id":"603cef7db9e30d000188f60c","name":"Indivior PLC","securities":[{"exchange":"OTC","symbol":"INVVY"},{"exchange":"OTC","symbol":"IZQVF"}]}],"created":1739348602,"date":"2025-02-12","drug":{"generic":false,"id":"6703c6f3a88f220001ad62e6","indication_symptom":[" For the treatment of moderate to severe opioid use disorder "],"name":"SUBLOCADE"},"event_type":"Provided Update","id":"67ac5a7adcc94e0001182ba2","nic_number":"","notes":"","outcome":"Indivior PLC provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® (buprenorphine extended-release) Injection, which was scheduled for February 7, 2025:","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43648323/indivior-statement-re-delayed-fda-approval-of-sublocade-label-changes","source_type":"Press Release","status":"","target_date":"","time":"03:23:22","updated":1739348663},{"commentary":"","companies":[{"cik":"1370053","id":"603cef7eb9e30d000188f7b0","name":"AnaptysBio Inc","securities":[{"exchange":"NASDAQ","symbol":"ANAB"}]}],"created":1739313485,"date":"2025-02-11","drug":{"generic":false,"id":"6192b70d3dfee90001535c80","indication_symptom":["Healthy Volunteer"],"name":"Rosnilimab (formerly ANB030)"},"event_type":"Provided Update","id":"67abd14ddcc94e0001182833","nic_number":"","notes":"","outcome":"AnaptysBio, Inc announced will host an investor call and live webcast to review top-line data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist of PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Wednesday, Feb. 12, 2025, at 8:30am ET / 5:30am PT.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43643332/anaptys-to-announce-top-line-data-from-phase-2b-trial-of-rosnilimab-a-pd-1-depleter-and-agonist-in","source_type":"Press Release","status":"","target_date":"","time":"17:38:05","updated":1739313552},{"commentary":"","companies":[{"cik":"1773427","id":"603cef7eb9e30d000188ffaf","name":"SpringWorks Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"SWTX"}]}],"created":1739313232,"date":"2025-02-11","drug":{"generic":false,"id":"60c90ac2619f580001b5f756","indication_symptom":["Adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN)"],"name":"Mirdametinib"},"event_type":"FDA Approval","id":"67abd050dcc94e00011827fe","nic_number":"","notes":"","outcome":"SpringWorks Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has approved GOMEKLI™ (mirdametinib), SpringWorks' MEK inhibitor, for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.1","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43643302/springworks-therapeutics-announces-fda-approval-of-gomekli-mirdametinib-for-the-treatment-of-adult","source_type":"Press Release","status":"FDA Approved","target_date":"","time":"17:33:52","updated":1739313316},{"commentary":"","companies":[{"cik":"","id":"679790413729b60001c5d169","name":"Bicara Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"BCAX"}]}],"created":1739309884,"date":"2025-02-11","drug":{"generic":false,"id":"67972479dc32a800013296cf","indication_symptom":["squamous cancer of the anal canal (SCAC)."],"name":"ficerafusp alfa"},"event_type":"Enrollment Update","id":"67abc33cdcc94e0001182711","nic_number":"","notes":"","outcome":"Bicara Therapeutics Inc. announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43639818/bicara-therapeutics-announces-first-patients-enrolled-in-fortifi-hn01-a-pivotal-phase-23-clinical-","source_type":"Press Release","status":"Phase 2/3","target_date":"","time":"16:38:04","updated":1739309963},{"commentary":"","companies":[{"cik":"","id":"67abc165b156400001bd86b3","name":"Cosmos Health Inc","securities":[{"exchange":"NASDAQ","symbol":"COSM"}]}],"created":1739309587,"date":"2025-02-11","drug":{"generic":false,"id":"67ab5890dcc94e000117f269","indication_symptom":["Weight Management Solution"],"name":"CCX0722"},"event_type":"Clinical Trial","id":"67abc213b1c67f00013697f2","nic_number":"","notes":"","outcome":"Cosmos Health Inc. announced that Clinical trials expected to complete in late 2025 or early 2026","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/ac43627268/cosmos-health-enters-final-development-phase-of-ccx0722-weight-management-solution-expected-produ","source_type":"Press Release","status":"","target_date":"","time":"16:33:07","updated":1739309758},{"commentary":"","companies":[{"cik":"","id":"67abc165b156400001bd86b3","name":"Cosmos Health Inc","securities":[{"exchange":"NASDAQ","symbol":"COSM"}]}],"created":1739309586,"date":"2025-02-11","drug":{"generic":false,"id":"67ab5890dcc94e000117f269","indication_symptom":["Weight Management Solution"],"name":"CCX0722"},"event_type":"Provided Update","id":"67abc212b1c67f00013697ea","nic_number":"","notes":"","outcome":"Cosmos Health Inc. announced that Product launch expected in the first or second quarter of 2026","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/ac43627268/cosmos-health-enters-final-development-phase-of-ccx0722-weight-management-solution-expected-produ","source_type":"Press Release","status":"","target_date":"","time":"16:33:06","updated":1739309757},{"commentary":"","companies":[{"cik":"","id":"67abc165b156400001bd86b3","name":"Cosmos Health Inc","securities":[{"exchange":"NASDAQ","symbol":"COSM"}]}],"created":1739309335,"date":"2025-02-11","drug":{"generic":false,"id":"67ab5890dcc94e000117f269","indication_symptom":["Weight Management Solution"],"name":"CCX0722"},"event_type":"Provided Update","id":"67abc117b156400001bd8691","nic_number":"","notes":"","outcome":"Cosmos Health Inc. announced that it is entering the final stage of development for CCX0722, its innovative weight management solution.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/ac43627268/cosmos-health-enters-final-development-phase-of-ccx0722-weight-management-solution-expected-produ","source_type":"Press Release","status":"","target_date":"","time":"16:28:55","updated":1739309757},{"commentary":"","companies":[{"cik":"1187953","id":"603cef7cb9e30d000188e6e8","name":"Creative Medical Technology Holdings Inc","securities":[{"exchange":"OTC","symbol":"CELZ"}]}],"created":1739283922,"date":"2025-02-11","drug":{"generic":false,"id":"63e3a07f691c6f0001d0ab60","indication_symptom":["Novel Cell Therapy for the Treatment of Type 1 Diabetes"],"name":"CELZ-201"},"event_type":"Follow-up data","id":"67ab5dd22b94b70001f829df","nic_number":"","notes":"","outcome":"Creative Medical Technology announced promising one-year follow-up data from the AlloStem ™ (CELZ-201) Type 2 Diabetes pilot study for late-stage patients.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43624700/creative-medical-technology-reports-positive-one-year-results-for-allostem-type-2-diabetes-program","source_type":"Press Release","status":"","target_date":"","time":"09:25:22","updated":1739283984},{"commentary":"","companies":[{"cik":"1743881","id":"603cef7eb9e30d000188ff2c","name":"BridgeBio Pharma Inc","securities":[{"exchange":"NASDAQ","symbol":"BBIO"}]}],"created":1739283849,"date":"2025-02-11","drug":{"generic":false,"id":"61c9b863a7cbdc00017384c7","indication_symptom":["Symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM)"],"name":"Acoramidis (ATTRibute-CM)"},"event_type":"Marketing authorization","id":"67ab5d892b94b70001f829c3","nic_number":"","notes":"","outcome":"BridgeBio Pharma, Inc. announced the European Commission has granted marketing authorization in the European Union (EU) for acoramidis, under the brand name BEYONTTRA™, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43624472/beyonttra-acoramidis-the-first-near-complete-ttr-stabilizer-90-approved-by-the-european-commission","source_type":"Press Release","status":"","target_date":"","time":"09:24:09","updated":1739283906},{"commentary":"","companies":[{"cik":"","id":"659ce7728fadc30001181054","name":"Femasys Inc","securities":[]}],"created":1739282444,"date":"2025-02-11","drug":{"generic":false,"id":"67ab5897dcc94e000117f26b","indication_symptom":["For Female Infertility Treatment "],"name":"FemaSeed®"},"event_type":"Provided Update","id":"67ab580c2b94b70001f82742","nic_number":"","notes":"","outcome":"Femasys Inc., announces the receipt of the Medicines \u0026 Healthcare products Regulatory Agency (MHRA) approvals for the FemaSeed® Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue® for tubal evaluation and FemCerv® for cervical cancer detection.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43623352/femasys-announces-uk-regulatory-approvals-for-femaseed-for-female-infertility-treatment-and-two-di","source_type":"Press Release","status":"UK MHRA Approval","target_date":"","time":"09:00:44","updated":1739282742},{"commentary":"","companies":[{"cik":"1680048","id":"603cef7eb9e30d000188fb23","name":"Mustang Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"MBIO"}]}],"created":1739281499,"date":"2025-02-11","drug":{"generic":false,"id":"672b3465057896000129c96d","indication_symptom":["To Treat Malignant Glioma"],"name":"MB-108"},"event_type":"Provided Update","id":"67ab545b2b94b70001f82577","nic_number":"","notes":"","outcome":"Moleculin Biotech, Inc. announced that Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the \"MIRACLE\" trial) in the first quarter of 2025,","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43622633/moleculin-receives-first-country-approval-in-europe-to-begin-recruiting-for-the-miracle-phase-3-rr","source_type":"Press Release","status":"","target_date":"2025-Q1","time":"08:44:59","updated":1739281552},{"commentary":"","companies":[{"cik":"1680048","id":"603cef7eb9e30d000188fb23","name":"Mustang Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"MBIO"}]}],"created":1739281446,"date":"2025-02-11","drug":{"generic":false,"id":"672b3465057896000129c96d","indication_symptom":["To Treat Malignant Glioma"],"name":"MB-108"},"event_type":"Regulatory Update","id":"67ab54262b94b70001f82568","nic_number":"","notes":"","outcome":"Moleculin Biotech, Inc., announced it has received first country regulatory approval in Europe to begin recruiting 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/25/02/n43622633/moleculin-receives-first-country-approval-in-europe-to-begin-recruiting-for-the-miracle-phase-3-rr","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:44:06","updated":1739281552},{"commentary":"","companies":[{"cik":"","id":"67ab52882b94b70001f823fa","name":"Kairos Pharma Ltd","securities":[{"exchange":"AMEX","symbol":"KAPA"}]}],"created":1739280997,"date":"2025-02-11","drug":{"generic":false,"id":"67a5efa2dcc94e00011758fc","indication_symptom":[" For castrate-resistant prostate cancer patients."],"name":"ENV105"},"event_type":"Provided Update","id":"67ab52652b94b70001f823f1","nic_number":"","notes":"","outcome":"Kairos Pharma Ltd announces the addition of Huntsman Cancer Institute in Salt Lake City, Utah for the Phase 2 clinical trial for ENV105 for castrate-resistant prostate cancer patients.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43622200/kairos-pharma-adds-huntsman-cancer-institute-for-phase-2-env105-clinical-trial","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:36:37","updated":1739281134},{"commentary":"","companies":[{"cik":"876343","id":"603cef78b9e30d000188b671","name":"Lineage Cell Therapeutics Inc","securities":[{"exchange":"AMEX","symbol":"LCTX"}]}],"created":1739279370,"date":"2025-02-11","drug":{"generic":false,"id":"65804de03d5b9b0001c0a249","indication_symptom":["Treatment of Chronic and Subacute Spinal Cord Injury"],"name":"OPC1"},"event_type":"Study Initiation","id":"67ab4c0a2b94b70001f8234f","nic_number":"","notes":"","outcome":"Lineage Cell Therapeutics, Inc announced today that the Company has initiated the DOSED (Delivery of Oligodendrocyte Progenitor Cells (OPCs) for Spinal Cord Injury: Evaluation of a Novel Device) clinical study.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43620799/lineage-initiates-clinical-study-of-opc1-for-spinal-cord-injury","source_type":"Press Release","status":"","target_date":"","time":"08:09:30","updated":1739279551},{"commentary":"","companies":[{"cik":"1759138","id":"603cef7eb9e30d000188ffed","name":"Cabaletta Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"CABA"}]}],"created":1739279245,"date":"2025-02-11","drug":{"generic":false,"id":"6548de99caf68a0001072ba8","indication_symptom":["For Treatment of Generalized Myasthenia Gravis"],"name":"CABA-201"},"event_type":"Updated data","id":"67ab4b8d2b94b70001f8233b","nic_number":"","notes":"","outcome":"Cabaletta Bio, Inc. announced that updated clinical data on resecabtagene autoleucel (rese-cel, formerly referred to as CABA-201) will be featured in presentations at the 2025 American Association for the Advancement of Science Annual Meeting, which is being held at the Hynes Convention Center in Boston, MA from February 13-15, 2025, and the 5th International Conference on Lymphocyte Engineering, which is being held at the Holiday Inn Munich – City Center in Munich, Germany from February 20-22, 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43620674/cabaletta-bio-announces-presentations-featuring-updated-clinical-data-on-rese-cel-at-upcoming-scie","source_type":"Press Release","status":"","target_date":"","time":"08:07:25","updated":1739279313},{"commentary":"","companies":[{"cik":"","id":"6113ec99b6abe40001edcd68","name":"IN8bio Inc.","securities":[{"exchange":"NASDAQ","symbol":"INAB"}]}],"created":1739279174,"date":"2025-02-11","drug":{"generic":false,"id":"6113ec43a3c6b90001e9ab65","indication_symptom":["Leukemia undergoing haploidentical stem cell transplant (HSCT)"],"name":"INB-100"},"event_type":"New Data","id":"67ab4b462b94b70001f82327","nic_number":"","notes":"","outcome":"IN8bio, Inc announced 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Phase 2 trial investigating RLYB212 in pregnant women at higher risk for HPA-1a alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43620705/rallybio-announces-initiation-of-dosing-in-rlyb212-phase-2-clinical-trial","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:03:10","updated":1739279153},{"commentary":"","companies":[{"cik":"","id":"6565d6f32803140001e088f6","name":"Rallybio Corporation","securities":[]}],"created":1739279028,"date":"2025-02-11","drug":{"generic":false,"id":"6565d6a72803140001e088a2","indication_symptom":["For the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia"],"name":"RLYB212"},"event_type":"Safety Data","id":"67ab4ab42b94b70001f822f4","nic_number":"","notes":"","outcome":"Rallybio Corporation announced that Pharmacokinetic (PK) and safety data from the second trimester are expected in the second quarter of 2025, with PK","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43620705/rallybio-announces-initiation-of-dosing-in-rlyb212-phase-2-clinical-trial","source_type":"Press Release","status":"","target_date":"2025-Q2","time":"08:03:48","updated":1739279153},{"commentary":"","companies":[{"cik":"","id":"6565d6f32803140001e088f6","name":"Rallybio Corporation","securities":[]}],"created":1739279067,"date":"2025-02-11","drug":{"generic":false,"id":"6565d6a72803140001e088a2","indication_symptom":["For the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia"],"name":"RLYB212"},"event_type":"Safety Data","id":"67ab4adb2b94b70001f822fe","nic_number":"","notes":"","outcome":"Rallybio Corporation announced that safety data at the time of delivery expected in the third quarter of 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subcutaneously.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43620172/silo-pharma-announces-positive-initial-pharmacokinetic-safety-and-tolerability-study-of-sp-26-for-","source_type":"Press Release","status":"","target_date":"","time":"07:47:38","updated":1739278112},{"commentary":"","companies":[{"cik":"1595097","id":"603cef7db9e30d000188f5ef","name":"Corbus Pharmaceuticals Holdings Inc","securities":[{"exchange":"NASDAQ","symbol":"CRBP"}]}],"created":1739277181,"date":"2025-02-11","drug":{"generic":false,"id":"64b059e39c212e0001506c5e","indication_symptom":["Targets the expression of Nectin-4 on cancer cells "],"name":"CRB-701"},"event_type":"Abstract","id":"67ab437ddcc94e000117ed36","nic_number":"","notes":"","outcome":"Corbus Pharmaceuticals announced that the abstract for its first-in-human dose escalation clinical study conducted in the United States and Europe (\"Western study\") of CRB-701 (SYS6002) has been released.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43619811/corbus-pharmaceuticals-announces-clinical-data-for-crb-701-from-western-dose-escalation-study-to-b","source_type":"Press Release","status":"","target_date":"","time":"07:33:01","updated":1739277231},{"commentary":"","companies":[{"cik":"1689813","id":"603cef7eb9e30d000188fa68","name":"Biohaven Pharmaceutical Holding Co Ltd","securities":[{"exchange":"NYSE","symbol":"BHVN"}]}],"created":1739277097,"date":"2025-02-11","drug":{"generic":false,"id":"6115ad2fb6abe40001ee0734","indication_symptom":["Spinocerebellar Ataxia (SCA) "],"name":"Troriluzole (SCA)"},"event_type":"FDA review","id":"67ab4329dcc94e000117ecf1","nic_number":"","notes":"","outcome":"Biohaven Ltd. announced that the US Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) for troriluzole for the treatment of adult patients with spinocerebellar ataxia (SCA) and has granted Priority Review.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43619822/biohaven-announces-fda-acceptance-and-priority-review-of-troriluzole-new-drug-application-for-the-","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"","time":"07:31:37","updated":1739277158},{"commentary":"","companies":[{"cik":"1438533","id":"603cef7db9e30d000188ebfc","name":"Travere Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"TVTX"}]}],"created":1739275946,"date":"2025-02-11","drug":{"generic":false,"id":"6494aff3943f950001b1e35b","indication_symptom":["Endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression"," generally a UPCR ≥1.5 g/g."],"name":"FILSPARI"},"event_type":"Provided Update","id":"67ab3eaadcc94e000117ea7e","nic_number":"","notes":"","outcome":"Travere Therapeutics, Inc. announced that The sNDA will be based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI and is expected to be submitted around the end of the first quarter of 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43618921/travere-therapeutics-to-submit-snda-for-filspari-sparsentan-in-fsgs","source_type":"Press Release","status":"","target_date":"2025-Q1","time":"07:12:26","updated":1739276006},{"commentary":"","companies":[{"cik":"1438533","id":"603cef7db9e30d000188ebfc","name":"Travere Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"TVTX"}]}],"created":1739275915,"date":"2025-02-11","drug":{"generic":false,"id":"6494aff3943f950001b1e35b","indication_symptom":["Endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression"," generally a UPCR ≥1.5 g/g."],"name":"FILSPARI"},"event_type":"FDA 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(sBLA)","target_date":"","time":"07:09:32","updated":1739275887},{"commentary":"","companies":[{"cik":"872589","id":"603cef78b9e30d000188ba95","name":"Regeneron Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"REGN"}]}],"created":1739275830,"date":"2025-02-11","drug":{"generic":false,"id":"646dfefcf3e2a000012539cd","indication_symptom":["Designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing."],"name":"Linvoseltamab (BCMAxCD3)"},"event_type":"PDUFA Date","id":"67ab3e36dcc94e000117ea1d","nic_number":"","notes":"","outcome":"Regeneron Pharmaceuticals announced that FDA decision expected by July 10, 2025","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43618899/linvoseltamab-bla-accepted-for-fda-review-for-the-treatment-of-relapsedrefractory-multiple-myeloma","source_type":"Press Release","status":"supplemental Biologics License 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surgery","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43618874/health-canada-approves-mercks-keytruda-pembrolizumab-for-the-treatment-of-adult-patients-with-rese","source_type":"Press Release","status":"Health Canada Approval","target_date":"","time":"07:03:14","updated":1739275483},{"commentary":"","companies":[{"cik":"1379006","id":"603cef7bb9e30d000188dbe6","name":"Nanoviricides Inc","securities":[{"exchange":"AMEX","symbol":"NNVC"}]}],"created":1739274558,"date":"2025-02-11","drug":{"generic":false,"id":"65536a7b7f07f10001c945eb","indication_symptom":["For MPox and Smallpox virus infections"],"name":"NV-387"},"event_type":"Provided Update","id":"67ab393edcc94e000117e7fb","nic_number":"","notes":"","outcome":"NanoViricides, Inc. declared today that it is ready to fight the bird flu with its revolutionary broad-spectrum antiviral drug NV-387, a drug that the Bird Flu virus H5N1 likely cannot escape despite its ability to mutate rapidly with genomic 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metastatic urothelial cancer (mUC) "],"name":"EV-302"},"event_type":"Follow-up results","id":"67aa792cb156400001bd421f","nic_number":"","notes":"","outcome":"Pfizer Inc and Astellas Pharma Inc announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus KEYTRUDA® (pembrolizumab), a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43610057/pfizer-and-astellas-padcev-enfortumab-vedotin-ejfv-plus-keytruda-pembrolizumab-shows-long-term-eff","source_type":"Press Release","status":"Phase 3","target_date":"","time":"17:09:48","updated":1739225614},{"commentary":"","companies":[{"cik":"","id":"61d3030630778300016a80ee","name":"Immix Biopharma, 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regimen.","outcome_brief":"","source_link":"https://www.benzinga.com/general/biotech/25/02/43592814/exclusive-nano-cap-tc-biopharm-concludes-initial-cohort-b-patient-dosing-in-mid-stage-leukemia-trial-data-readout-by-end-of-2025","source_type":"Press Release","status":"Phase 2b","target_date":"","time":"09:18:39","updated":1739197191},{"commentary":"","companies":[{"cik":"1729944","id":"603cef7eb9e30d000188fdab","name":"IMAC Holdings Inc","securities":[{"exchange":"NASDAQ","symbol":"IMAC"}]}],"created":1739197008,"date":"2025-02-10","drug":{"generic":false,"id":"67a5efa3dcc94e0001175902","indication_symptom":["In Predicting Breast Cancer Therapy Response"],"name":"AKT–mTOR"},"event_type":"Publication","id":"67aa0a50dcc94e000117a7a8","nic_number":"","notes":"","outcome":"Ignite Proteomics LLC, a subsidiary of IMAC Holdings, Inc. announces the publication of a significant study in the British Journal of Cancer titled \"Functional activation of the AKT–mTOR signalling axis in a real-world metastatic breast cancer cohort\".","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43592798/ignite-proteomics-announces-publication-of-study-demonstrating-superiority-of-protein-activation-a","source_type":"Press Release","status":"","target_date":"","time":"09:16:48","updated":1739197102},{"commentary":"","companies":[{"cik":"1622229","id":"603cef7eb9e30d000188fc40","name":"Cogent Biosciences Inc","securities":[{"exchange":"NASDAQ","symbol":"COGT"}]}],"created":1739196937,"date":"2025-02-10","drug":{"generic":false,"id":"62a33cdc82e96e000155202b","indication_symptom":["Advanced Systemic Mastocytosis (AdvSM)"],"name":"Bezuclastinib"},"event_type":"Poster Presentation","id":"67aa0a09dcc94e000117a78e","nic_number":"","notes":"","outcome":"Cogent Biosciences, Inc announced an upcoming poster for bezuclastinib at the 2025 American Academy of Allergy Asthma \u0026 Immunology Annual Meeting (AAAAI) being held in San Diego, CA, February 28-March 3, 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is not adequately controlled with topical prescription therapies or when those therapies are not advisable.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43588402/nektar-therapeutics-receives-fast-track-designation-for-rezpegaldesleukin-for-the-treatment-of-mod","source_type":"Press Release","status":"Fast Track Designation","target_date":"","time":"09:12:05","updated":1739196775},{"commentary":"","companies":[{"cik":"1285819","id":"603cef7bb9e30d000188d970","name":"Omeros Corp","securities":[{"exchange":"NASDAQ","symbol":"OMER"}]}],"created":1739196642,"date":"2025-02-10","drug":{"generic":false,"id":"6045f55fe74cfd0001ed6961","indication_symptom":["Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)"],"name":"Narsoplimab"},"event_type":"Presentation","id":"67aa08e2dcc94e000117a741","nic_number":"","notes":"","outcome":"Omeros Corporation announced two presentations that will be featured at the 2025 Tandem Meetings – the Transplantation \u0026 Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research, to be held February 12-15, 2025 in Honolulu, Hawaii.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43592291/omeros-corporation-announces-upcoming-presentations-detailing-outcomes-of-narsoplimab-treatment-fo","source_type":"Press Release","status":"","target_date":"","time":"09:10:42","updated":1739196680},{"commentary":"","companies":[{"cik":"","id":"61029fc2b403570001890faa","name":"Palisade Bio, Inc.","securities":[{"exchange":"NASDAQ","symbol":"PALI"}]}],"created":1739196181,"date":"2025-02-10","drug":{"generic":false,"id":"6616450f84104e0001863de5","indication_symptom":["For patients affected by UC."],"name":"PALI-2108"},"event_type":"Data Presentation","id":"67aa0715dcc94e000117a6d5","nic_number":"","notes":"","outcome":"Palisade Bio, Inc. announced the presentation of positive preclinical data from PALI-2108, an orally administered, colon-specific phosphodiesterase-4 (PDE4) inhibitor prodrug is in development for patients with ulcerative colitis (UC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43591737/palisade-bio-presents-positive-preclinical-data-of-pali-2108-for-the-treatment-of-ulcerative-colit","source_type":"Press Release","status":"","target_date":"","time":"09:03:01","updated":1739196224},{"commentary":"","companies":[{"cik":"882796","id":"603cef78b9e30d000188b665","name":"BioCryst Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"BCRX"}]}],"created":1739196040,"date":"2025-02-10","drug":{"generic":false,"id":"603e3ae4b3e2040001494e19","indication_symptom":["Hereditary angioedema (HAE)"],"name":"ORLADEYO (berotralstat)"},"event_type":"Abstract Presentation","id":"67aa0688dcc94e000117a6af","nic_number":"","notes":"","outcome":"BioCryst Pharmaceuticals, Inc. announced that the company will present five abstracts featuring new clinical and real-world outcomes with oral, once-daily ORLADEYO® (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) at the 2025 American Academy of Allergy, Asthma \u0026 Immunology (AAAAI) / World Allergy Organization (WAO) joint congress.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43591350/biocryst-to-present-new-orladeyo-berotralstat-results-from-apex-p-pediatric-trial-at-2025-american","source_type":"Press Release","status":"","target_date":"","time":"09:00:40","updated":1739196127},{"commentary":"","companies":[{"cik":"949858","id":"603cef78b9e30d000188bb77","name":"Achieve Life Sciences Inc","securities":[{"exchange":"NASDAQ","symbol":"ACHV"}]}],"created":1739195927,"date":"2025-02-10","drug":{"generic":false,"id":"66571aaaf86556000186d475","indication_symptom":[" For smoking cessation and nicotine dependence",""],"name":"ORCA-OL"},"event_type":"NDA 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announced that the Data Safety Monitoring Committee (DSMC) has recently completed its second independent review of the ongoing ORCA-OL trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen in individuals who smoke cigarettes or vape nicotine.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43591298/achieve-life-sciences-announces-positive-outcome-of-second-data-safety-monitoring-committee-review","source_type":"Press Release","status":"Data Safety and Monitoring Board (DSMB) Review","target_date":"","time":"08:57:55","updated":1739196023},{"commentary":"","companies":[{"cik":"1055726","id":"603cef79b9e30d000188bfeb","name":"Inovio Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"INO"}]}],"created":1739193416,"date":"2025-02-10","drug":{"generic":false,"id":"64f86125add8280001ff7b2d","indication_symptom":["For the Treatment of Recurrent Respiratory Papillomatosis"],"name":"INO-3107"},"event_type":"Abstract","id":"67a9fc48b156400001bd08a6","nic_number":"","notes":"","outcome":"INOVIO announced that an abstract describing the immunological activity of INO-3107 will be presented as a poster at the following scientific conference:","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43590435/immune-response-data-for-ino-3107-to-be-presented-as-a-poster-at-american-association-for-cancer-r","source_type":"Press Release","status":"","target_date":"","time":"08:16:56","updated":1739193453},{"commentary":"","companies":[{"cik":"","id":"62180a9d6f3eb90001e03887","name":"Jasper Therapeutics, Inc.","securities":[{"exchange":"NASDAQ","symbol":"JSPR"}]}],"created":1739193344,"date":"2025-02-10","drug":{"generic":false,"id":"651d470408e89000019cfd76","indication_symptom":["To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)"],"name":"Briquilimab"},"event_type":"Poster Presentation","id":"67a9fc00b156400001bd0895","nic_number":"","notes":"","outcome":"Jasper Therapeutics, announced five poster presentations and an oral presentation of briquilimab data at the AAAAI 2025 Annual Meeting, being held February 28 - March 3, 2025, in San Diego, CA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43590284/jasper-therapeutics-announces-briquilimab-presentations-at-the-american-academy-of-allergy-asthma-","source_type":"Press Release","status":"","target_date":"","time":"08:15:44","updated":1739193390},{"commentary":"","companies":[{"cik":"","id":"656d94032803140001e13ceb","name":"Palvella Therapeutics, Inc","securities":[]}],"created":1739193217,"date":"2025-02-10","drug":{"generic":false,"id":"67811eeb9a903000017e3bae","indication_symptom":["In the Journal of Vascular Anomalies"],"name":"QTORIN™ rapamycin"},"event_type":"Provided 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cancer"],"name":"osimertinib"},"event_type":"Publication","id":"67a9fad1b156400001bd0860","nic_number":"","notes":"","outcome":"Ocean Biomedical announced newly published research findings demonstrating the ability of its proprietary cancer immunotherapy candidates to favorably interact with tyrosine kinase inhibitors (TKI), such as osimertinib that are used to treat non-small cell lung cancer (NSCLC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43590161/ocean-biomedical-announces-breakthrough-findings-in-egfr-mutant-lung-cancer-and-plans-for-fda-alig","source_type":"Press Release","status":"","target_date":"","time":"08:10:41","updated":1739193178},{"commentary":"","companies":[{"cik":"","id":"67a9fa412b94b70001f7dd3d","name":"Radiopharm Theranostics","securities":[{"exchange":"NASDAQ","symbol":"RADX"}]}],"created":1739192859,"date":"2025-02-10","drug":{"generic":false,"id":"67a5efa3dcc94e0001175906","indication_symptom":["For for successful detection of brain metastases"],"name":"RAD 101"},"event_type":"Publication","id":"67a9fa1b2b94b70001f7dd35","nic_number":"","notes":"","outcome":"Radiopharm Theranostics announce the publication of a novel imaging approach demonstrating proof-of-concept for the use of RAD 101 for successful detection of brain metastases (both treatment-naïve and previously treated) from a variety of primary solid tumors.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43590166/new-clinical-trial-data-highlights-rad-101-18f-pivalate-successfully-detects-brain-metastases","source_type":"Press Release","status":"","target_date":"","time":"08:07:39","updated":1739193006},{"commentary":"","companies":[{"cik":"","id":"6148bacbf3823900010003f9","name":"Tempest Therapeutics, Inc.","securities":[{"exchange":"NASDAQ","symbol":"TPST"}]}],"created":1739192646,"date":"2025-02-10","drug":{"generic":false,"id":"6148ba898cd4c100016b5b4b","indication_symptom":["First-Line Regimen for Hepatocellular Carcinoma"],"name":"TPST-1120"},"event_type":"Designation Grant","id":"67a9f946b1c67f0001360eb4","nic_number":"","notes":"","outcome":"Tempest Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43590151/tempest-granted-fast-track-designation-from-the-u-s-food-and-drug-administration-for-amezalpat-to-","source_type":"Press Release","status":"Fast Track Designation","target_date":"","time":"08:04:06","updated":1739192702},{"commentary":"","companies":[{"cik":"1539029","id":"603cef7eb9e30d000188f856","name":"Clearside Biomedical Inc","securities":[{"exchange":"NASDAQ","symbol":"CLSD"}]}],"created":1739190074,"date":"2025-02-10","drug":{"generic":false,"id":"60c89d94619f580001b5e07d","indication_symptom":["Neovascular age-related macular degeneration (wet AMD)"],"name":"CLS-AX (axitinib injectable suspension"},"event_type":"Presentation","id":"67a9ef3ab156400001bd07cd","nic_number":"","notes":"","outcome":"Clearside Biomedical, announced today that two subgroup analyses were presented from the ODYSSEY Phase 2b clinical trial at the Angiogenesis, Exudation, and Degeneration 2025 meeting.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43588531/clearside-biomedical-announces-additional-data-from-the-cls-ax-odyssey-phase-2b-trial-presented-at","source_type":"Press Release","status":"Phase 2b","target_date":"","time":"07:21:14","updated":1739190129},{"commentary":"","companies":[{"cik":"","id":"603cef79b9e30d000188c56c","name":"BioRestorative Therapies Inc","securities":[]}],"created":1739189926,"date":"2025-02-10","drug":{"generic":false,"id":"62019623e008470001d6fdb0","indication_symptom":["Chronic Lumbar Disc Disease"],"name":"BRTX-100"},"event_type":"Provided Update","id":"67a9eea6b156400001bd07ac","nic_number":"","notes":"","outcome":"BioRestorative Therapies, announced that its Vice President of Research and Development, Francisco Silva, presented 26–52 week blinded data from the first 15 patients (up from 10 reported previously) with chronic lumbar disc disease (\"cLDD\") enrolled in the ongoing Phase 2 clinical trial of BRTX-100 at the Orthopaedic Research Society (\"ORS\") annual meeting, taking place February 7-11, 2025 in Phoenix, AZ.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43588337/brtx-100-front-and-center-at-ors-2025","source_type":"Press Release","status":"","target_date":"","time":"07:18:46","updated":1739189987},{"commentary":"","companies":[{"cik":"1348911","id":"603cef7eb9e30d000188f64d","name":"KalVista Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"KALV"}]}],"created":1739189827,"date":"2025-02-10","drug":{"generic":false,"id":"65522310a54dc20001b24526","indication_symptom":["Therapy for hereditary angioedema (HAE)."],"name":"sebetralstat"},"event_type":"Data Presentation","id":"67a9ee43b156400001bd0797","nic_number":"","notes":"","outcome":"KalVista Pharmaceuticals, Inc announced the presentation of novel data related to long-term prophylaxis and sebetralstat at the Western Society of Allergy, Asthma \u0026 Immunology (WSAAI) 2025 Annual Meeting taking place in Waimea, HI from February 9-13, 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43588378/kalvista-pharmaceuticals-presents-new-sebetralstat-data-at-the-western-society-of-allergy-asthma-i","source_type":"Press Release","status":"","target_date":"","time":"07:17:07","updated":1739189904},{"commentary":"","companies":[{"cik":"1579428","id":"603cef7eb9e30d000188f7e1","name":"Axsome Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"AXSM"}]}],"created":1739189769,"date":"2025-02-10","drug":{"generic":false,"id":"65770ed9f754e50001dfb950","indication_symptom":["Patients with Major Depressive Disorder "],"name":"Auvelity"},"event_type":"Provided Update","id":"67a9ee09b156400001bd0787","nic_number":"","notes":"","outcome":"Axsome Therapeutics, Inc. announced that it has entered into a settlement agreement with Teva Pharmaceuticals, Inc.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43588347/axsome-therapeutics-announces-settlement-agreement-resolving-auvelity-dextromethorphan-hbr-bupropi","source_type":"Press Release","status":"","target_date":"","time":"07:16:09","updated":1739189808},{"commentary":"","companies":[{"cik":"1711754","id":"603cef7eb9e30d000188fe71","name":"INmune Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"INMB"}]}],"created":1739189637,"date":"2025-02-10","drug":{"generic":false,"id":"67a5efa3dcc94e0001175908","indication_symptom":["For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)"],"name":"CORDStrom"},"event_type":"Provided Update","id":"67a9ed85b1c67f0001360d11","nic_number":"","notes":"","outcome":"INmune Bio, announced today, following a Type C meeting with the U.S. Food and Drug Administration (FDA), its intent to submit a BLA in the US and Marketing Authorization Application (MAA) in the UK and EU supported by data from the MissionEB clinical trial investigating CORDStrom as a disease-modifying therapy for treating RDEB in pediatric patients.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43588338/inmune-bio-announces-plan-to-submit-fda-biologics-license-application-bla-seeking-approval-of-cord","source_type":"Press Release","status":"Biologics License Applications (BLA)","target_date":"","time":"07:13:57","updated":1739189755},{"commentary":"","companies":[{"cik":"14272","id":"603cef78b9e30d000188b6a3","name":"Bristol-Myers Squibb Company","securities":[{"exchange":"NYSE","symbol":"BMY"},{"exchange":"OTC","symbol":"BMYMP"}]}],"created":1739189541,"date":"2025-02-10","drug":{"generic":false,"id":"60c1ff910b7e3900011071a8","indication_symptom":["Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL)"],"name":"Breyanzi (lisocabtagene maraleucel)"},"event_type":"Endpoint 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Additional data were provided on the durability of aflibercept expression for up to two years.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43579183/4dmt-presents-positive-52-week-results-from-phase-2b-cohort-of-prism-wet-amd-study-and-long-term-d","source_type":"Press Release","status":"Phase 2b","target_date":"","time":"05:18:15","updated":1739182748},{"commentary":"","companies":[{"cik":"872589","id":"603cef78b9e30d000188ba95","name":"Regeneron Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"REGN"}]}],"created":1739182609,"date":"2025-02-08","drug":{"generic":false,"id":"64998c341d538a0001e6547e","indication_symptom":["For the treatment of patients with wet age-related macular degeneration (wAMD)"," diabetic macular edema (DME) and diabetic retinopathy (DR)",""],"name":"Aflibercept"},"event_type":"Presentation","id":"67a9d211b1c67f0001360b83","nic_number":"","notes":"","outcome":"Regeneron Pharmaceuticals, Inc. announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO), including those with central, branch and hemiretinal vein occlusions.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43579472/eylea-hd-aflibercept-injection-8-mg-positive-phase-3-results-in-patients-with-macular-edema-follow","source_type":"Press Release","status":"Phase 3","target_date":"","time":"05:16:49","updated":1739182660},{"commentary":"","companies":[{"cik":"1746473","id":"603cef7fb9e30d0001890111","name":"Pliant Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"PLRX"}]}],"created":1738966548,"date":"2025-02-07","drug":{"generic":false,"id":"650c1e648345120001a3d104","indication_symptom":["Primary Sclerosing Cholangitis and Suspected Liver Fibrosis"],"name":"Bexotegrast"},"event_type":"Enrollment Update","id":"67a68614dcc94e0001179b7f","nic_number":"","notes":"","outcome":"Pliant Therapeutics, Inc announced that following a prespecified data review and recommendations by the trial's independent Data Safety Monitoring Board (DSMB), the Company has voluntarily paused enrollment and dosing in the ongoing BEACON-IPF Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43574512/pliant-therapeutics-provides-update-on-beacon-ipf-a-phase-2b3-trial-in-patients-with-idiopathic-pu","source_type":"Press Release","status":"Phase 2b","target_date":"","time":"17:15:48","updated":1738966612},{"commentary":"","companies":[{"cik":"","id":"6063a3ebdbb1f50001cf73c9","name":"Eledon Pharmaceuticals, Inc.","securities":[]}],"created":1738963222,"date":"2025-02-07","drug":{"generic":false,"id":"671f7d9ad453ac0001621926","indication_symptom":["For Type 1 Diabetes "],"name":"tegoprubart"},"event_type":"Provided Update","id":"67a67916b156400001bcf481","nic_number":"","notes":"","outcome":"Eledon Pharmaceuticals, Inc. announced that tegoprubart, the company's investigational anti-CD40L antibody, was used as a key component of the immunosuppression therapy regimen in a patient who recently received a transplanted kidney from a genetically modified pig.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43562070/eledon-pharmaceuticals-announces-use-of-tegoprubart-as-key-component-of-immunosuppression-regimen-","source_type":"Press Release","status":"","target_date":"","time":"16:20:22","updated":1738963276},{"commentary":"","companies":[{"cik":"78003","id":"603cef79b9e30d000188c196","name":"Pfizer Inc","securities":[{"exchange":"NYSE","symbol":"PFE"}]}],"created":1738962895,"date":"2025-02-07","drug":{"generic":false,"id":"65f8219bcad84c000180aa7a","indication_symptom":["In the treatment of adult patients with complicated intra-abdominal infections (cIAI)"],"name":"EMBLAVEO"},"event_type":"Approved","id":"67a677cfb156400001bcf45a","nic_number":"","notes":"EMBLAVEO was jointly developed with Pfizer. AbbVie holds the rights to commercialize the therapy in the U.S. and Canada, with Pfizer responsible for commercialization in all other areas.","outcome":"AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO™ (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43569835/u-s-fda-approves-emblaveo-aztreonam-and-avibactam-for-the-treatment-of-adults-with-complicated-int","source_type":"Press Release","status":"FDA Approved","target_date":"","time":"16:14:55","updated":1738963094},{"commentary":"","companies":[{"cik":"946644","id":"603cef78b9e30d000188bf67","name":"AIM ImmunoTech Inc","securities":[{"exchange":"AMEX","symbol":"AIM"}]}],"created":1738936373,"date":"2025-02-07","drug":{"generic":false,"id":"608811d2eb87ad000173bac0","indication_symptom":["COVID-19 and Other Respiratory Viral 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depression."],"name":"NARCAN"},"event_type":"Provided Update","id":"67a605a1dcc94e0001175aa2","nic_number":"","notes":"","outcome":"Emergent BioSolutions announced today that it is raising awareness of the Ready to Rescue initiative in New Orleans with pro football legend and NARCAN® Nasal Spray spokesperson, Emmitt Smith, as the city welcomes an anticipated 83,000 fans for the Big Game.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43558233/emergent-biosolutions-and-pro-football-legend-emmitt-smith-raise-awareness-of-ready-to-rescue-camp","source_type":"Press Release","status":"","target_date":"","time":"08:07:45","updated":1738933705},{"commentary":"","companies":[{"cik":"922247","id":"603cef79b9e30d000188c51e","name":"Cyclo Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"CYTH"}]}],"created":1738933574,"date":"2025-02-07","drug":{"generic":false,"id":"66d99e96c2ed5b00011a37a5","indication_symptom":["For the treatment of Niemann-Pick 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Presentation","id":"67a60513dcc94e0001175a7c","nic_number":"","notes":"","outcome":"Cyclo Therapeutics, Inc announced the presentation of data from its ongoing Pivotal Phase 3 global study (TransportNPC™) evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (\"NPC1\") at the 21st Annual WORLDSymposium™ in San Diego, CA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43558210/cyclo-therapeutics-presents-positive-preliminary-data-from-ongoing-phase-3-transportnpc-open-label","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:05:23","updated":1738933642},{"commentary":"","companies":[{"cik":"","id":"67a604842b94b70001f79175","name":"Maze Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"MAZE"}]}],"created":1738933324,"date":"2025-02-07","drug":{"generic":false,"id":"67a5efa4dcc94e000117590a","indication_symptom":["For APOL1 Kidney Disease"],"name":"MZE829"},"event_type":"Dose Update","id":"67a6044cdcc94e0001175a54","nic_number":"","notes":"","outcome":"Maze Therapeutics, Inc announced the first patient has been dosed in the company's Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients with APOL1 kidney disease (AKD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43558018/maze-therapeutics-doses-first-patient-in-phase-2-horizon-clinical-trial-evaluating-mze829-as-a-pot","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:02:04","updated":1738933473},{"commentary":"","companies":[{"cik":"1710340","id":"603cef7eb9e30d000188fd62","name":"Eton Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"ETON"}]}],"created":1738929410,"date":"2025-02-07","drug":{"generic":false,"id":"6411a3e700af890001092ecd","indication_symptom":["For the treatment of an endocrinology "],"name":"ET-600"},"event_type":"Provided 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disease"],"name":"mirikizumab-mrkz"},"event_type":"Results","id":"67a5f4badcc94e00011759e4","nic_number":"","notes":"","outcome":"Eli Lilly and Company announced results from the VIVID-2 open-label extension study, which showed the majority of patients with moderately to severely active Crohn's disease receiving two years of continuous treatment with Omvoh® (mirikizumab-mrkz) achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43556289/most-patients-on-lillys-omvoh-mirikizumab-mrkz-for-crohns-disease-achieved-sustained-clinical-remi","source_type":"Press Release","status":"","target_date":"","time":"06:55:38","updated":1738929391},{"commentary":"","companies":[{"cik":"","id":"655206ffb3615100015df138","name":"Lipella Pharmaceuticals Inc","securities":[]}],"created":1738928235,"date":"2025-02-06","drug":{"generic":false,"id":"655204e1207b9d0001912b70","indication_symptom":["For the treatment of oral Graft-versus-Host Disease (GvHD). "],"name":"LP-310"},"event_type":"Approved","id":"67a5f06bb1c67f000135bc5b","nic_number":"","notes":"","outcome":"Lipella Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval for an Expanded Access Program (EAP) for LP-310, an oral rinse formulation designed to treat oral lichen planus (OLP).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43522207/lipella-pharmaceuticals-granted-fda-approval-for-expanded-access-program-for-lp-310-in-oral-lichen","source_type":"Press Release","status":"FDA Approved","target_date":"","time":"06:37:15","updated":1738928313},{"commentary":"","companies":[{"cik":"1684144","id":"603cef7db9e30d000188f399","name":"Zomedica Corp","securities":[{"exchange":"AMEX","symbol":"ZOM"}]}],"created":1738928028,"date":"2025-02-06","drug":{"generic":false,"id":"67a5efa4dcc94e000117590c","indication_symptom":["In Equine PPID Diagnosis"],"name":"TRUFORMA"},"event_type":"Groundbreaking update","id":"67a5ef9cdcc94e00011758f9","nic_number":"","notes":"","outcome":"Zomedica Corp. announced a groundbreaking update to its endogenous ACTH (eACTH) assay for equine plasma on the TRUFORMA biosensor platform.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/ac43522947/zomedica-launches-the-truforma-r-enhanced-endogenous-acth-assay-to-aid-in-equine-ppid-diagnosis","source_type":"Press Release","status":"","target_date":"","time":"06:33:48","updated":1738928189},{"commentary":"","companies":[{"cik":"310158","id":"603cef78b9e30d000188b9a4","name":"Merck \u0026 Co Inc","securities":[{"exchange":"NYSE","symbol":"MRK"}]}],"created":1738926898,"date":"2025-02-06","drug":{"generic":false,"id":"67a21b92dcc94e000116896a","indication_symptom":["For the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma"],"name":"LINE-010"},"event_type":"Clinical Trial","id":"67a5eb32b1c67f000135bbf0","nic_number":"","notes":"","outcome":"Merck announced the initiation of waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) compared to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) alone, for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43523295/merck-announces-phase-3-waveline-010-trial-initiation-evaluating-zilovertamab-vedotin-an-investiga","source_type":"Press Release","status":"Phase 3","target_date":"","time":"06:14:58","updated":1738926988},{"commentary":"","companies":[{"cik":"","id":"6164d697d8eaa700011dad59","name":"Immuneering Corporation","securities":[{"exchange":"NASDAQ","symbol":"IMRX"}]}],"created":1738926783,"date":"2025-02-06","drug":{"generic":false,"id":"6164d655d5cb080001d23979","indication_symptom":["Solid tumors"],"name":"IMM-1-104"},"event_type":"Provided Update","id":"67a5eabfb1c67f000135bbd1","nic_number":"","notes":"","outcome":"Immuneering Corporation announced a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo (cemiplimab).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43523598/immuneering-announces-clinical-supply-agreement-with-regeneron-pharmaceuticals-to-evaluate-imm-1-1","source_type":"Press Release","status":"","target_date":"","time":"06:13:03","updated":1738926835},{"commentary":"","companies":[{"cik":"911216","id":"603cef79b9e30d000188c149","name":"Palatin Technologies Inc","securities":[{"exchange":"AMEX","symbol":"PTN"}]}],"created":1738926540,"date":"2025-02-06","drug":{"generic":false,"id":"67a21b92dcc94e000116896c","indication_symptom":[" For the treatment of obesity. "],"name":"BMT-801"},"event_type":"Clinical Study","id":"67a5e9ccb1c67f000135bb80","nic_number":"","notes":"","outcome":"Palatin Technologies, Inc. announced the completion of its Phase 2 BMT-801 clinical study of the co-administration of MC4R bremelanotide + GLP-1/GIP tirzepatide for the treatment of obesity. The last patient enrolled has completed their last visit.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43524706/palatin-completes-phase-2-obesity-study-with-mc4r-bremelanotide-plus-glp-1gip-tirzepatide","source_type":"Press Release","status":"Phase 2","target_date":"","time":"06:09:00","updated":1738926676},{"commentary":"","companies":[{"cik":"1501697","id":"603cef7eb9e30d000188fb97","name":"X4 Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"XFOR"}]}],"created":1738926479,"date":"2025-02-06","drug":{"generic":false,"id":"6576bcd5a2fb150001c8fb42","indication_symptom":["In people diagnosed with idiopathic"," cyclic"," or congenital neutropenia."],"name":"Mavorixafor"},"event_type":"Provided Update","id":"67a5e98fb1c67f000135bb70","nic_number":"","notes":"","outcome":"X4 Pharmaceuticals announced today a restructuring of its workforce and capital spending to focus efforts on advancing mavorixafor to treat those with chronic neutropenia, while also optimizing its U.S. promotion of XOLREMDI® (mavorixafor), approved for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis), a rare immunodeficiency.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43524970/x4-pharmaceuticals-announces-strategic-restructuring-to-drive-value-and-maximize-opportunity-for-m","source_type":"Press Release","status":"","target_date":"","time":"06:07:59","updated":1738926517},{"commentary":"","companies":[{"cik":"1135951","id":"603cef78b9e30d000188becd","name":"Dr Reddy's Laboratories Ltd","securities":[{"exchange":"NYSE","symbol":"RDY"}]}],"created":1738926243,"date":"2025-02-06","drug":{"generic":false,"id":"67a21b93dcc94e000116896e","indication_symptom":["a biosimilar candidate to Darzalex® \u0026 Darzalex Faspro®"],"name":"HLX15"},"event_type":"Provided Update","id":"67a5e8a3b1c67f000135bb4b","nic_number":"","notes":"","outcome":"Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd. announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) related to the development and commercialization of HLX15, Henlius's investigational daratumumab biosimilar candidate to Darzalex® \u0026 Darzalex Faspro®.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43525424/dr-reddys-enters-into-collaboration-with-henlius-for-commercialization-of-hlx15-daratumumab-a-bios","source_type":"Press Release","status":"","target_date":"","time":"06:04:03","updated":1738926431},{"commentary":"","companies":[{"cik":"1401914","id":"603cef7db9e30d000188f45f","name":"Dare Bioscience Inc","securities":[{"exchange":"NASDAQ","symbol":"DARE"}]}],"created":1738925936,"date":"2025-02-06","drug":{"generic":false,"id":"67a21b93dcc94e0001168970","indication_symptom":["For HPV-related cervical diseases"],"name":"DARE-HPV"},"event_type":"Provided Update","id":"67a5e770b1c67f000135bb1c","nic_number":"","notes":"","outcome":"Daré Bioscience, announced that it received a Notice of Award of a grant from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43525542/dar-bioscience-announces-funding-award-notice-from-the-national-institutes-of-health-nih-national-","source_type":"Press Release","status":"","target_date":"","time":"05:58:56","updated":1738926062},{"commentary":"","companies":[{"cik":"1430306","id":"603cef7cb9e30d000188e1dc","name":"Tonix Pharmaceuticals Holding Corp","securities":[{"exchange":"NASDAQ","symbol":"TNXP"}]}],"created":1738925867,"date":"2025-02-06","drug":{"generic":false,"id":"63d920ca3b88450001b81d00","indication_symptom":["Humanized monoclonal antibody "],"name":"TNX-1500"},"event_type":"Top-line results","id":"67a5e72bb1c67f000135bb06","nic_number":"","notes":"","outcome":"Tonix Pharmaceuticals announced positive topline results from its Phase 1, single ascending dose trial of TNX-1500 (Fc-modified humanized anti-CD40L monoclonal antibody, or mAb)* in healthy participants.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43525535/tonix-pharmaceuticals-announces-positive-topline-results-from-phase-1-trial-for-tnx-1500-a-next-ge","source_type":"Press Release","status":"Phase 1","target_date":"","time":"05:57:47","updated":1738925916},{"commentary":"","companies":[{"cik":"","id":"6617e89740e824000148ad52","name":"TransCode Therapeutics Inc","securities":[]}],"created":1738925796,"date":"2025-02-06","drug":{"generic":false,"id":"661d203bed9ebb00017183ae","indication_symptom":["In Patients with Advanced Solid Tumors"],"name":"TTX-MC138"},"event_type":"Enrollment Update","id":"67a5e6e4b1c67f000135baee","nic_number":"","notes":"","outcome":"TransCode Therapeutics, Inc. announced that Cohort 3 of its Phase 1 clinical trial enrolled three patients and all have been dosed with TTX-MC138, its lead candidate.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43525644/transcode-therapeutics-announces-completion-of-cohort-3-initial-dosing-with-lead-candidate-in-phas","source_type":"Press Release","status":"Phase 1","target_date":"","time":"05:56:36","updated":1738925839},{"commentary":"","companies":[{"cik":"1746466","id":"603cef7eb9e30d000188fdcf","name":"Equillium Inc","securities":[{"exchange":"NASDAQ","symbol":"EQ"}]}],"created":1738925726,"date":"2025-02-06","drug":{"generic":false,"id":"605241b936622a000156cdf9","indication_symptom":["Acute graft-versus-host disease (aGVHD)"],"name":"itolizumab"},"event_type":"Positive Results","id":"67a5e69eb1c67f000135bad8","nic_number":"","notes":"","outcome":"Equillium, Inc announced positive topline results from the Phase 2 study evaluating itolizumab in the treatment of moderate to severe ulcerative colitis (UC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43525609/equillium-announces-positive-data-from-phase-2-study-evaluating-itolizumab-in-patients-with-modera","source_type":"Press Release","status":"Phase 2","target_date":"","time":"05:55:26","updated":1738925777},{"commentary":"","companies":[{"cik":"","id":"603cef7db9e30d000188f36c","name":"Allarity Therapeutics AS","securities":[{"exchange":"NASDAQ","symbol":"ALLR"}]}],"created":1738925561,"date":"2025-02-06","drug":{"generic":false,"id":"656f21fc258cdd000172e5c1","indication_symptom":[" For ovarian cancer (AOC)"],"name":"Stenoparib"},"event_type":"Provided Update","id":"67a5e5f9b1c67f000135baa3","nic_number":"","notes":"","outcome":"Allarity Therapeutics, Inc announced plans for the next step in advancing the clinical development of stenoparib toward FDA approval in advanced ovarian cancer.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43525545/allarity-therapeutics-announces-expansion-of-phase-2-clinical-trial-to-accelerate-development-of-s","source_type":"Press Release","status":"","target_date":"","time":"05:52:41","updated":1738925690},{"commentary":"","companies":[{"cik":"","id":"603cef7db9e30d000188f36c","name":"Allarity Therapeutics AS","securities":[{"exchange":"NASDAQ","symbol":"ALLR"}]}],"created":1738925640,"date":"2025-02-06","drug":{"generic":false,"id":"656f21fc258cdd000172e5c1","indication_symptom":[" For ovarian cancer (AOC)"],"name":"Stenoparib"},"event_type":"Enrollment Update","id":"67a5e648b1c67f000135bab9","nic_number":"","notes":"","outcome":"Allarity Therapeutics, Inc announced that Patient enrollment is expected to begin in the first half of 2025","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43525545/allarity-therapeutics-announces-expansion-of-phase-2-clinical-trial-to-accelerate-development-of-s","source_type":"Press Release","status":"","target_date":"2025-H1","time":"05:54:00","updated":1738925690},{"commentary":"","companies":[{"cik":"1001233","id":"603cef78b9e30d000188baef","name":"Sangamo Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"SGMO"}]}],"created":1738925374,"date":"2025-02-06","drug":{"generic":false,"id":"6091f7842bc27400010a525a","indication_symptom":["FabryDisease"],"name":"ST-920"},"event_type":"Updated data","id":"67a5e53eb1c67f000135ba65","nic_number":"","notes":"","outcome":"Sangamo Therapeutics, Inc announced updated data from the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43526025/sangamo-therapeutics-announces-updated-phase-12-staar-study-data-in-fabry-disease-showing-sustaine","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"05:49:34","updated":1738925522},{"commentary":"","companies":[{"cik":"1001233","id":"603cef78b9e30d000188baef","name":"Sangamo Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"SGMO"}]}],"created":1738925457,"date":"2025-02-06","drug":{"generic":false,"id":"6091f7842bc27400010a525a","indication_symptom":["FabryDisease"],"name":"ST-920"},"event_type":"BLA Filing","id":"67a5e591b1c67f000135ba7d","nic_number":"","notes":"","outcome":"Sangamo Therapeutics, Inc announced that Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) anticipated in second half of 2025","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43526025/sangamo-therapeutics-announces-updated-phase-12-staar-study-data-in-fabry-disease-showing-sustaine","source_type":"Press Release","status":"Biologics License Applications (BLA)","target_date":"2025-H2","time":"05:50:57","updated":1738925521},{"commentary":"","companies":[{"cik":"1001233","id":"603cef78b9e30d000188baef","name":"Sangamo Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"SGMO"}]}],"created":1738925415,"date":"2025-02-06","drug":{"generic":false,"id":"6091f7842bc27400010a525a","indication_symptom":["FabryDisease"],"name":"ST-920"},"event_type":"Data","id":"67a5e567b1c67f000135ba71","nic_number":"","notes":"","outcome":"Sangamo Therapeutics, Inc. announced Data to support Accelerated Approval pathway expected in first half of 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obesity.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43526823/wave-life-sciences-announces-initiation-of-phase-1-inlight-clinical-trial-of-wve-007-in-obesity","source_type":"Press Release","status":"Phase 1","target_date":"","time":"05:46:23","updated":1738925294},{"commentary":"","companies":[{"cik":"1714899","id":"603cef7eb9e30d000188fbc4","name":"Denali Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"DNLI"}]}],"created":1738924956,"date":"2025-02-06","drug":{"generic":false,"id":"6489b22d38ab3c0001934f74","indication_symptom":["Gene therapy that reduces the rate of abnormal bleeding in eligible people with hemophilia B by enabling the body to continuously produce factor IX"," the deficient protein in hemophilia B. "],"name":"DNL310"},"event_type":"Analysis","id":"67a5e39cb1c67f000135ba20","nic_number":"","notes":"","outcome":"Denali Therapeutics Inc","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43535932/denali-therapeutics-announces-primary-analysis-and-long-term-follow-up-of-phase-12-study-in-hunter","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"05:42:36","updated":1738925010},{"commentary":"","companies":[{"cik":"","id":"6523e601b474e10001dc734d","name":"Hyperfine Inc","securities":[]}],"created":1738924756,"date":"2025-02-06","drug":{"generic":false,"id":"651d470408e89000019cfd6e","indication_symptom":[" Portable MR Imaging® System"],"name":"Swoop® System Sequences"},"event_type":"Presentation","id":"67a5e2d4b1c67f000135ba0e","nic_number":"","notes":"","outcome":"Hyperfine, Inc announced the presentation of two studies at the 2025 International Stroke Conference (ISC), which provide evidence supporting the value of AI-powered portable MRI in acute ischemic stroke triage and diagnosis.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43544670/hyperfine-reports-on-growing-evidence-for-the-use-of-swoop-system-images-in-stroke-diagnosis-prese","source_type":"Press Release","status":"","target_date":"","time":"05:39:16","updated":1738924808},{"commentary":"","companies":[{"cik":"1422143","id":"603cef7eb9e30d000188f7a9","name":"Kura Oncology Inc","securities":[{"exchange":"NASDAQ","symbol":"KURA"}]}],"created":1738928831,"date":"2025-02-05","drug":{"generic":false,"id":"63e4ec275f23fa0001076b13","indication_symptom":["Treatment of genetically defined AML patients with high unmet need"],"name":"Ziftomenib"},"event_type":"Positive Results","id":"67a5f2bfb1c67f000135bd0a","nic_number":"","notes":"","outcome":"Kura Oncology, Inc. announced positive topline results from KOMET-001, the Phase 2 registration-directed trial of ziftomenib, a highly selective, once-daily, oral investigational menin inhibitor, in patients with relapsed/refractory (R/R) NPM1-mutant (NPM1-m) acute myeloid leukemia (AML).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43509177/kura-oncology-and-kyowa-kirin-announce-positive-ziftomenib-monotherapy-registrational-trial-and-po","source_type":"Press Release","status":"Phase 2","target_date":"","time":"06:47:11","updated":1738928914},{"commentary":"","companies":[{"cik":"1422143","id":"603cef7eb9e30d000188f7a9","name":"Kura Oncology Inc","securities":[{"exchange":"NASDAQ","symbol":"KURA"}]}],"created":1738928859,"date":"2025-02-05","drug":{"generic":false,"id":"63e4ec275f23fa0001076b13","indication_symptom":["Treatment of genetically defined AML patients with high unmet need"],"name":"Ziftomenib"},"event_type":"NDA Filing","id":"67a5f2dbb1c67f000135bd22","nic_number":"","notes":"","outcome":"Kura is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ziftomenib in the second quarter of 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43509177/kura-oncology-and-kyowa-kirin-announce-positive-ziftomenib-monotherapy-registrational-trial-and-po","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"2025-Q2","time":"06:47:39","updated":1738928913},{"commentary":"","companies":[{"cik":"","id":"623b775265a64100016d964a","name":"Rani Therapeutics Holdings, Inc.","securities":[{"exchange":"NASDAQ","symbol":"RANI"}]}],"created":1738928757,"date":"2025-02-05","drug":{"generic":false,"id":"6710fb124a361900010a7430","indication_symptom":["For the treatment of obesity"],"name":"RaniPill"},"event_type":"New Data","id":"67a5f275b1c67f000135bcc3","nic_number":"","notes":"","outcome":"Rani Therapeutics Holdings, announced new pharmacokinetic and pharmacodynamic data from a preclinical study evaluating the oral delivery of the glucagon-like peptide-1 receptor (GLP-1) agonist semaglutide administered via the RaniPill® capsule.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43509393/rani-therapeutics-announces-preclinical-data-demonstrating-successful-oral-delivery-of-semaglutide","source_type":"Press Release","status":"","target_date":"","time":"06:45:57","updated":1738928809},{"commentary":"","companies":[{"cik":"1607678","id":"603cef7db9e30d000188f53a","name":"Viking Therapeutics Inc","securities":[{"exchange":"NASDAQ","symbol":"VKTX"}]}],"created":1738928683,"date":"2025-02-05","drug":{"generic":false,"id":"61dc8dd72925770001ed8dff","indication_symptom":["Metabolic disorders"],"name":"VK2735"},"event_type":"Clinical Update","id":"67a5f22bb1c67f000135bcb1","nic_number":"","notes":"","outcome":"Viking Therapeutics, Inc. provided clinical 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adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43513460/new-england-journal-of-medicine-publishes-efficacy-of-zenocutuzumab-in-nrg1-fusion-positive-cancer","source_type":"Press Release","status":"Phase 2","target_date":"","time":"06:41:09","updated":1738928517},{"commentary":"","companies":[{"cik":"","id":"6154826373a5f300019b73de","name":"Recursion","securities":[{"exchange":"NASDAQ","symbol":"RXRX"}]}],"created":1738928396,"date":"2025-02-05","drug":{"generic":false,"id":"623487d002807e000111c3e8","indication_symptom":["Cerebral Cavernous Malformation (CCM)"],"name":"REC-994"},"event_type":"Data","id":"67a5f10cb1c67f000135bc73","nic_number":"","notes":"","outcome":"Recursion reported 12 month data from the Phase 2 study (SYCAMORE) of REC-994, the first industry sponsored Phase 2 trial completed in Cerebral Cavernous Malformations (CCM).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43514580/recursion-presents-phase-2-data-for-rec-994-in-ccm-in-late-breaking-oral-presentation-at-the-inter","source_type":"Press Release","status":"Phase 2","target_date":"","time":"06:39:56","updated":1738928439},{"commentary":"","companies":[{"cik":"1521036","id":"603cef7db9e30d000188f52a","name":"Lantheus Holdings Inc","securities":[{"exchange":"NASDAQ","symbol":"LNTH"}]}],"created":1738762499,"date":"2025-02-05","drug":{"generic":false,"id":"60af9702c878010001d5bafd","indication_symptom":["Metastasis or recurrence of prostate cancer"],"name":"PYLARIFY (piflufolastat F 18)"},"event_type":"Presentation","id":"67a36903b156400001bc31f3","nic_number":"","notes":"","outcome":"Lantheus Holdings, announced piflufolastat F 18 data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, taking place February 13-15, 2025, in San Francisco, CA.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43493644/lantheus-announces-presentations-featuring-pylarify-piflufolastat-f-18-data-at-the-asco-gu-meeting","source_type":"Press Release","status":"","target_date":"","time":"08:34:59","updated":1738762555},{"commentary":"","companies":[{"cik":"1472091","id":"603cef7eb9e30d000188f79c","name":"PDS Biotechnology Corp","securities":[{"exchange":"NASDAQ","symbol":"PDSB"}]}],"created":1738761033,"date":"2025-02-05","drug":{"generic":false,"id":"64c0cdbe9c212e0001522256","indication_symptom":["Evaluating the safety and efficacy of PDS0101 in combination with Merck's anti-PD-1 therapy"," KEYTRUDA® (pembrolizumab) versus KEYTRUDA® monotherapy."],"name":"VERSATILE-003"},"event_type":"Provided Update","id":"67a36349b156400001bc3165","nic_number":"","notes":"","outcome":"PDS Biotechnology today reaffirmed the Company's guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43492592/pds-biotech-reaffirms-guidance-for-first-quarter-initiation-of-versatile-003-phase-3-clinical-tria","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:10:33","updated":1738761076},{"commentary":"","companies":[{"cik":"946644","id":"603cef78b9e30d000188bf67","name":"AIM ImmunoTech Inc","securities":[{"exchange":"AMEX","symbol":"AIM"}]}],"created":1738760946,"date":"2025-02-05","drug":{"generic":false,"id":"608811d2eb87ad000173bac0","indication_symptom":["COVID-19 and Other Respiratory Viral Diseases"],"name":"Ampligen"},"event_type":"Approved","id":"67a362f2b156400001bc3147","nic_number":"","notes":"","outcome":"AIM ImmunoTech Inc. announced Safety Committee approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM's Ampligen® (rintatolimod) and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (\"DURIPANC\").","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43492529/erasmus-medical-center-safety-committee-grants-approval-to-proceed-with-phase-2-study-of-ampligen-","source_type":"Press Release","status":"Phase 1b/2","target_date":"","time":"08:09:06","updated":1738761018},{"commentary":"","companies":[{"cik":"1649094","id":"603cef7fb9e30d0001890127","name":"Vaxcyte Inc","securities":[{"exchange":"NASDAQ","symbol":"PCVX"}]}],"created":1738760872,"date":"2025-02-05","drug":{"generic":false,"id":"64c0cdbe9c212e000152225a","indication_symptom":["For the Prevention of Invasive Pneumococcal Disease "],"name":"VAX-31"},"event_type":"Dosing 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the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the ACR-368 OncoSignature assay, a multiplex immunofluorescence assay for the identification of endometrial cancer patients who may benefit from ACR-368 treatment.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43492554/acrivon-therapeutics-announces-fda-has-granted-breakthrough-device-designation-for-acr-368-oncosig","source_type":"Press Release","status":"Breakthrough Device Designation","target_date":"","time":"08:06:40","updated":1738760852},{"commentary":"","companies":[{"cik":"1515673","id":"603cef7db9e30d000188f3ae","name":"Ultragenyx Pharmaceutical Inc","securities":[{"exchange":"NASDAQ","symbol":"RARE"}]}],"created":1738760715,"date":"2025-02-05","drug":{"generic":false,"id":"666a8b3fe56ade0001156a70","indication_symptom":[" For Sanfilippo syndrome type A (MPS IIIA)"],"name":"UX111"},"event_type":"New 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(PD).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43462326/supernus-announces-fda-approval-of-onapgo-apomorphine-hydrochloride-for-parkinsons-disease","source_type":"Press Release","status":"FDA Approved","target_date":"","time":"09:04:14","updated":1738677997},{"commentary":"","companies":[{"cik":"","id":"653a5131c697190001de8357","name":"PaxMedica Inc","securities":[]}],"created":1738677783,"date":"2025-02-04","drug":{"generic":false,"id":"6501af9d9ab00f00016a4d0c","indication_symptom":["For Trypanosoma brucei rhodesiense"],"name":"FemaSeed"},"event_type":"Provided Update","id":"67a21e17dcc94e0001168a19","nic_number":"","notes":"","outcome":"Femasys Inc. announces the receipt of the Israeli Medical Device Division of the Ministry of Health's (AMAR) approvals for the FemaSeed® Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue® for tubal evaluation and FemCerv® for cervical cancer detection.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43462358/femasys-announces-israeli-regulatory-approvals-for-femaseed-for-female-infertility-treatment-and-t","source_type":"Press Release","status":"Israeli Ministry of Health Approval","target_date":"","time":"09:03:03","updated":1738677839},{"commentary":"","companies":[{"cik":"1027838","id":"603cef7eb9e30d000188f863","name":"Tactile Systems Technology Inc","securities":[{"exchange":"NASDAQ","symbol":"TCMD"}]}],"created":1738677682,"date":"2025-02-04","drug":{"generic":false,"id":"66e7db7dc2ed5b00011b924c","indication_symptom":["Pneumatic compression platform"],"name":"Nimbl"},"event_type":"Provided Update","id":"67a21db2dcc94e0001168a08","nic_number":"","notes":"","outcome":"Tactile Systems Technology announced that Nimbl, its next-generation pneumatic compression platform, is now commercially available throughout the United States (U.S.) for the treatment of both upper and lower extremity lymphedema.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43459986/tactile-medical-expands-launch-of-nimbl-to-include-patients-with-lower-extremity-lymphedema","source_type":"Press Release","status":"","target_date":"","time":"09:01:22","updated":1738677728},{"commentary":"","companies":[{"cik":"","id":"65266f4cb6b19d00018a76c0","name":"MAIA Biotechnology Inc","securities":[]}],"created":1738677496,"date":"2025-02-04","drug":{"generic":false,"id":"669f98e8d9891400015004aa","indication_symptom":["In patients with advanced non-small cell lung cancer (NSCLC) "],"name":"THIO-101"},"event_type":"Positive Data","id":"67a21cf8dcc94e00011689f0","nic_number":"","notes":"","outcome":"MAIA Biotechnology, Inc announced positive updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron's immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43462032/maia-biotechnology-announces-positive-efficacy-updates-for-phase-2-thio-101-trial-in-advanced-non-","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:58:16","updated":1738677540},{"commentary":"","companies":[{"cik":"","id":"606b65f2653896000188fe31","name":"IceCure Medical Ltd","securities":[]}],"created":1738677412,"date":"2025-02-04","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":"Marketing authorization","id":"67a21ca4dcc94e00011689d7","nic_number":"","notes":"","outcome":"IceCure Medical Ltd. announced that FDA's decision on ProSense® market authorization for early-stage breast cancer expected Q1 2025","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43461266/icecures-prosense-in-the-spotlight-at-society-of-interventional-oncology-sio-annual-meeting-award-","source_type":"Press Release","status":"","target_date":"2025-Q1","time":"08:56:52","updated":1738677477},{"commentary":"","companies":[{"cik":"","id":"606b65f2653896000188fe31","name":"IceCure Medical Ltd","securities":[]}],"created":1738677363,"date":"2025-02-04","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":"67a21c73dcc94e00011689cc","nic_number":"","notes":"","outcome":"IceCure Medical Ltd. announced its participation as one of the sponsors of the Breast Cryoablation Mini Masterclass held during the 2025 Society of Interventional Oncology (SIO) Annual Meeting in Las Vegas, which took place January 29 to February 3, 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43461266/icecures-prosense-in-the-spotlight-at-society-of-interventional-oncology-sio-annual-meeting-award-","source_type":"Press Release","status":"","target_date":"","time":"08:56:03","updated":1738677476},{"commentary":"","companies":[{"cik":"883975","id":"603cef79b9e30d000188c1ef","name":"Microbot Medical Inc","securities":[{"exchange":"NASDAQ","symbol":"MBOT"}]}],"created":1738677252,"date":"2025-02-04","drug":{"generic":false,"id":"66b9fbd3157a570001811ce9","indication_symptom":["Device Study"],"name":"LIBERTY® Endovascular Robotic Surgical System"},"event_type":"Late Breaking Presentation","id":"67a21c04dcc94e00011689a8","nic_number":"","notes":"","outcome":"Microbot Medical Inc. announced the acceptance of a late-breaking abstract that will be presented at the upcoming Society of Interventional Radiology (SIR) annual meeting, being held in Nashville, TN on March 29 - April 2, 2025.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43461234/microbot-medical-announces-late-breaking-abstract-acceptance-at-the-society-of-interventional-radi","source_type":"Press Release","status":"","target_date":"2025-04-02","time":"08:54:12","updated":1738677314},{"commentary":"","companies":[{"cik":"1555280","id":"603cef7db9e30d000188f121","name":"Zoetis Inc","securities":[{"exchange":"NYSE","symbol":"ZTS"}]}],"created":1738677071,"date":"2025-02-04","drug":{"generic":false,"id":"67a21b92dcc94e0001168968","indication_symptom":["For Canine Osteoarthritis (OA) Pain"],"name":"Librela"},"event_type":"Provided Update","id":"67a21b4fdcc94e0001168944","nic_number":"","notes":"","outcome":"Zoetis Inc announced that it has updated the U.S. label for Librela® (bedinvetmab injection), following its submission of a supplement to the U.S. Food and Drug Administration (FDA).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43460129/zoetis-announces-u-s-label-update-for-librela-bedinvetmab-injection-a-treatment-to-control-canine-","source_type":"Press Release","status":"","target_date":"","time":"08:51:11","updated":1738677229},{"commentary":"","companies":[{"cik":"","id":"66be054ac55fed00014b5b0f","name":"Glucotrack Inc","securities":[{"exchange":"NASDAQ","symbol":"GCTK"}]}],"created":1738675680,"date":"2025-02-04","drug":{"generic":false,"id":"67a20a50b1c67f000134efa3","indication_symptom":["Vein-Based Continuous Glucose Monitor"],"name":"Subclavian"},"event_type":"Provided Update","id":"67a215e0dcc94e000116881b","nic_number":"","notes":"","outcome":"Glucotrack, Inc. announced the successful completion of its first in human clinical study, marking a significant milestone in continuous glucose monitoring.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43460168/glucotrack-announces-successful-completion-of-its-first-human-clinical-study-of-continuous-blood-g","source_type":"Press Release","status":"","target_date":"","time":"08:28:00","updated":1738675767},{"commentary":"","companies":[{"cik":"","id":"6284da526a002e00012f5d86","name":"IO Biotech","securities":[{"exchange":"NASDAQ","symbol":"IOBT"}]}],"created":1738675201,"date":"2025-02-04","drug":{"generic":false,"id":"67a20a50b1c67f000134efa7","indication_symptom":["Arginase 1-Targeting Therapeutic Cancer Vaccine Candidate"],"name":"IO112"},"event_type":"NDA Filing","id":"67a21401dcc94e00011687bd","nic_number":"","notes":"","outcome":"IO Biotech announced that Submission of Investigational New Drug Application (IND) to US FDA expected in 2025 –","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43460283/io-biotech-announces-publication-of-preclinical-data-investigating-immune-modulatory-effects-of-io","source_type":"Press Release","status":"New Drug Application (NDA)","target_date":"","time":"08:20:01","updated":1738675274},{"commentary":"","companies":[{"cik":"","id":"6284da526a002e00012f5d86","name":"IO Biotech","securities":[{"exchange":"NASDAQ","symbol":"IOBT"}]}],"created":1738675087,"date":"2025-02-04","drug":{"generic":false,"id":"67a20a50b1c67f000134efa7","indication_symptom":["Arginase 1-Targeting Therapeutic Cancer Vaccine Candidate"],"name":"IO112"},"event_type":"Publication","id":"67a2138fdcc94e0001168789","nic_number":"","notes":"","outcome":"IO Biotech announced the publication of results from a preclinical study of its second immune-modulatory therapeutic cancer vaccine candidate, IO112, targeting arginase 1 (Arg1), in the Journal for ImmunoTherapy of Cancer.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43460283/io-biotech-announces-publication-of-preclinical-data-investigating-immune-modulatory-effects-of-io","source_type":"Press Release","status":"","target_date":"","time":"08:18:07","updated":1738675274},{"commentary":"","companies":[{"cik":"","id":"6544b88f5cf4640001b2a7b4","name":"Mineralys Therapeutics Inc","securities":[]}],"created":1738674987,"date":"2025-02-04","drug":{"generic":false,"id":"6544b85ccba3b6000149a432","indication_symptom":["For the treatment of uncontrolled and resistant hypertension "],"name":"lorundrostat"},"event_type":"Enrollment Update","id":"67a2132bdcc94e0001168766","nic_number":"","notes":"","outcome":"Mineralys Therapeutics, Inc announced that it has completed enrollment in the Explore-CKD Phase 2 trial evaluating the efficacy and safety of lorundrostat for the treatment of hypertension in subjects with CKD and albuminuria, despite receiving stable treatment with an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) and an SGLT2 inhibitor..","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43460033/mineralys-therapeutics-completes-enrollment-in-explore-ckd-phase-2-trial-of-lorundrostat-for-the-t","source_type":"Press Release","status":"Phase 2","target_date":"","time":"08:16:27","updated":1738675056},{"commentary":"","companies":[{"cik":"1509261","id":"603cef7db9e30d000188effd","name":"Rezolute Inc","securities":[{"exchange":"NASDAQ","symbol":"RZLT"}]}],"created":1738674785,"date":"2025-02-04","drug":{"generic":false,"id":"67a20a50b1c67f000134efa9","indication_symptom":["For Hypoglycemia Due to Congenital Hyperinsulinism"],"name":"Ersodetug"},"event_type":"Enrollment Update","id":"67a21261dcc94e0001168714","nic_number":"","notes":"","outcome":"Rezolute, Inc. announced that sunRIZE enrollment completion expected in Q2 2025","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43459940/rezolute-provides-update-on-its-phase-3-sunrize-study-of-ersodetug-for-the-treatment-of-hypoglycem","source_type":"Press Release","status":"","target_date":"2025-Q2","time":"08:13:05","updated":1738674946},{"commentary":"","companies":[{"cik":"1509261","id":"603cef7db9e30d000188effd","name":"Rezolute Inc","securities":[{"exchange":"NASDAQ","symbol":"RZLT"}]}],"created":1738674665,"date":"2025-02-04","drug":{"generic":false,"id":"67a20a50b1c67f000134efa9","indication_symptom":["For Hypoglycemia Due to Congenital Hyperinsulinism"],"name":"Ersodetug"},"event_type":"Provided Update","id":"67a211e9dcc94e00011686e6","nic_number":"","notes":"","outcome":"Rezolute, Inc. announced outcomes from an independent Data Monitoring Committee (DMC) review of the open label arm (OLA) portion of the sunRIZE Phase 3 study of ersodetug for the treatment of hypoglycemia due to congenital hyperinsulinism (HI) and provided additional study updates including guidance on its upcoming interim analysis (IA) by the DMC.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43459940/rezolute-provides-update-on-its-phase-3-sunrize-study-of-ersodetug-for-the-treatment-of-hypoglycem","source_type":"Press Release","status":"Phase 3","target_date":"","time":"08:11:05","updated":1738674945},{"commentary":"","companies":[{"cik":"","id":"6731f7bfb3805500018f1d41","name":"Pyxis Oncology Inc","securities":[{"exchange":"NASDAQ","symbol":"PYXS"}]}],"created":1738672827,"date":"2025-02-04","drug":{"generic":false,"id":"672b343b86a8560001f8f305","indication_symptom":["In multiple types of solid tumors"],"name":"PYX-201"},"event_type":"Provided Update","id":"67a20abbdcc94e0001168526","nic_number":"","notes":"","outcome":"Pyxis Oncology, Inc. announced significant progress in its clinical program for PYX-201, a first-in-concept antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM), which is highly expressed in various tumor types.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43459095/pyxis-oncology-initiates-new-pyx-201-combination-trial-and-initiates-cohort-expansions-of-ongoing-","source_type":"Press Release","status":"","target_date":"","time":"07:40:27","updated":1738672865},{"commentary":"","companies":[{"cik":"1087294","id":"603cef7ab9e30d000188d416","name":"Cumberland Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"CPIX"}]}],"created":1738672702,"date":"2025-02-04","drug":{"generic":false,"id":"67a20a51b1c67f000134efab","indication_symptom":[" In Duchenne Muscular Dystrophy Heart Disease"],"name":"ifetroban"},"event_type":"Top-line results","id":"67a20a3eb1c67f000134ef9f","nic_number":"","notes":"","outcome":"Cumberland Pharmaceuticals announced positive top-line results from its Phase 2 FIGHT DMD trial.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43459112/cumberland-pharmaceuticals-announces-breakthrough-results-from-the-phase-2-fight-dmd-trial-in-duch","source_type":"Press Release","status":"Phase 2","target_date":"","time":"07:38:22","updated":1738672804},{"commentary":"","companies":[{"cik":"1082554","id":"603cef79b9e30d000188c311","name":"United Therapeutics Corp","securities":[{"exchange":"NASDAQ","symbol":"UTHR"}]}],"created":1738670707,"date":"2025-02-04","drug":{"generic":false,"id":"60424146e74cfd0001f68f97","indication_symptom":["Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD)"],"name":"Tyvaso (Treprostinil)"},"event_type":"Enrollment Update","id":"67a202732b94b70001f6afb4","nic_number":"","notes":"","outcome":"United Therapeutics Corporation announced full enrollment of the TETON 1 study evaluating the use of Tyvaso® (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43458111/united-therapeutics-corporation-announces-full-enrollment-of-the-teton-1-study-of-inhaled-treprost","source_type":"Press Release","status":"","target_date":"","time":"07:05:07","updated":1738670763},{"commentary":"","companies":[{"cik":"1553846","id":"603cef7db9e30d000188ee31","name":"Redhill Biopharma Ltd","securities":[{"exchange":"NASDAQ","symbol":"RDHL"}]}],"created":1738670631,"date":"2025-02-04","drug":{"generic":false,"id":"6070a5f46d58b1000154842d","indication_symptom":["Severe COVID-19 pneumonia"],"name":"Opaganib"},"event_type":"Study Initiation","id":"67a202272b94b70001f6af9e","nic_number":"","notes":"","outcome":"RedHill Biopharma Ltd announced the initiation of a Phase 2 clinical study to evaluate the efficacy of opaganib[3] in combination with darolutamide[4] in men with metastatic castrate-resistant prostate cancer (mCRPC).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/n43458150/redhill-announces-initiation-of-phase-2-study-of-opaganib-and-darolutamide-in-advanced-prostate-ca","source_type":"Press Release","status":"Phase 2","target_date":"","time":"07:03:51","updated":1738670673},{"commentary":"","companies":[{"cik":"","id":"618c515280db050001bdf6f3","name":"NeuroPace, Inc.","securities":[{"exchange":"NASDAQ","symbol":"NPCE"}]}],"created":1738616824,"date":"2025-02-03","drug":{"generic":false,"id":"618c511f80db050001bdf6e4","indication_symptom":["Drug-resistant idiopathic generalized epilepsy"],"name":"RNS System"},"event_type":"Oral presentation","id":"67a12ff82b94b70001f6a26b","nic_number":"","notes":"","outcome":"NeuroPace, Inc announced that an abstract featuring data from the Post-approval Study of the RNS System has been selected for an oral presentation at the upcoming American Academy of Neurology (AAN) 2025 Annual Meeting, which is being held April 5th – 9th in San Diego.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43448629/neuropace-announces-upcoming-oral-presentation-of-data-from-the-post-approval-study-of-the-rns-sys","source_type":"Press Release","status":"","target_date":"","time":"16:07:04","updated":1738616880},{"commentary":"","companies":[{"cik":"","id":"62b3773a118ebc0001427b67","name":"Alpha Tau Medical Ltd.","securities":[{"exchange":"NASDAQ","symbol":"DRTS"}]}],"created":1738589851,"date":"2025-02-03","drug":{"generic":false,"id":"62b3771c9c3cd100011418ce","indication_symptom":["Prostate cancer"],"name":"Alpha DaRT"},"event_type":"FDA Approval","id":"67a0c69b2b94b70001f66509","nic_number":"","notes":"","outcome":"Alpha Tau Medical Ltd announced an approval from the U.S. Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) supplement to the IDE previously announced on Jan 27, 2025, which had approved a clinical study examining the combination of Alpha DaRT and first-line chemotherapy in 12 patients with newly diagnosed metastatic pancreatic cancer, allowing expansion of the clinical trial to a broader group of pancreatic cancer patients.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43432752/alpha-tau-announces-fda-approval-of-ide-supplement-to-expand-pilot-trial-of-alpha-dart-to-thirty-p","source_type":"Press Release","status":"Investigational Device Exemption (IDE) Application","target_date":"","time":"08:37:31","updated":1738589912},{"commentary":"","companies":[{"cik":"1615219","id":"603cef7eb9e30d000188f64e","name":"Salarius Pharmaceuticals Inc","securities":[{"exchange":"NASDAQ","symbol":"SLRX"}]}],"created":1738589210,"date":"2025-02-03","drug":{"generic":false,"id":"679be6ef3c7fb90001b8462a","indication_symptom":["For Hematologic Cancers"],"name":"azacitidine"},"event_type":"Enrollment Update","id":"67a0c41a2b94b70001f6646e","nic_number":"","notes":"","outcome":"Salarius Pharmaceuticals, Inc. announces that patient enrollment will resume in the investigator-initiated Phase 1/2 clinical trial evaluating seclidemstat in combination with azacitidine for the treatment of myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML).","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43431719/salarius-pharmaceuticals-announces-patient-enrollment-to-resume-in-investigator-initiated-phase-12","source_type":"Press Release","status":"Phase 1/2","target_date":"","time":"08:26:50","updated":1738589303},{"commentary":"","companies":[{"cik":"","id":"67a0c3bfb156400001bb88e6","name":"Jupiter Neurosciences Inc","securities":[{"exchange":"NASDAQ","symbol":"JUNS"}]}],"created":1738589090,"date":"2025-02-03","drug":{"generic":false,"id":"679be6f03c7fb90001b8462c","indication_symptom":["For Parkinson's disease."],"name":"JOTROL"},"event_type":"Provided Update","id":"67a0c3a2b156400001bb88cb","nic_number":"","notes":"","outcome":"Jupiter Neurosciences, Inc. announced it has entered into an agreement with Catalent Pharma Solutions, LLC (\"Catalent\") for the production of JOTROL™ softgel capsules to support Jupiter's upcoming Phase 2a clinical trial in Parkinson's disease.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/g43431716/jupiter-neurosciences-announces-jotrol-manufacturing-agreement-with-catalent-to-support-phase-2a-p","source_type":"Press Release","status":"","target_date":"","time":"08:24:50","updated":1738589200},{"commentary":"","companies":[{"cik":"1774163","id":"603cef7eb9e30d000188fde5","name":"Innovent Biologics Inc","securities":[{"exchange":"OTC","symbol":"IVBIY"},{"exchange":"GREY","symbol":"IVBXF"}]}],"created":1738589028,"date":"2025-02-03","drug":{"generic":false,"id":"621eb25e6dd755000147016e","indication_symptom":["ROS1-Positive Non-Small Cell Lung Cancer"],"name":"Taletrectinib"},"event_type":"Provided Update","id":"67a0c364b156400001bb88ab","nic_number":"","notes":"","outcome":"Nuvation Bio Inc announced it has initiated an Expanded Access Program (EAP) for taletrectinib in the U.S. for the treatment of patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) when no comparable or satisfactory alternative therapy options are available.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43431770/nuvation-bio-announces-expanded-access-program-in-the-u-s-for-taletrectinib-in-advanced-ros1-posit","source_type":"Press Release","status":"","target_date":"","time":"08:23:48","updated":1738589067},{"commentary":"","companies":[{"cik":"200406","id":"603cef79b9e30d000188c04b","name":"Johnson \u0026 Johnson","securities":[{"exchange":"NYSE","symbol":"JNJ"}]}],"created":1738586033,"date":"2025-02-03","drug":{"generic":false,"id":"679be6f03c7fb90001b8462e","indication_symptom":["For Advanced EGFR-Mutated Non-Small Cell 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therapy.","outcome_brief":"","source_link":"https://www.jnj.com/media-center/press-releases/chmp-recommends-subcutaneous-rybrevant-amivantamab-for-the-treatment-of-patients-with-advanced-egfr-mutated-non-small-cell-lung-cancer","source_type":"Press Release","status":"European Medicines Agency (EMA)","target_date":"","time":"07:33:53","updated":1738586286},{"commentary":"","companies":[{"cik":"924717","id":"603cef79b9e30d000188c221","name":"Surmodics Inc","securities":[{"exchange":"NASDAQ","symbol":"SRDX"}]}],"created":1738585490,"date":"2025-02-03","drug":{"generic":false,"id":"64870f0818fb560001fa21d2","indication_symptom":["Intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter."],"name":"Pounce™ LP Thrombectomy System"},"event_type":"Provided Update","id":"67a0b592dcc94e000116366b","nic_number":"","notes":"","outcome":"Surmodics, Inc. announced the successful early clinical use of its Pounce™ XL Thrombectomy System.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43430030/surmodics-announces-successful-early-clinical-use-of-pounce-xl-thrombectomy-system-suitable-for-no","source_type":"Press Release","status":"","target_date":"","time":"07:24:50","updated":1738585536},{"commentary":"","companies":[{"cik":"1728117","id":"603cef7eb9e30d000188fe47","name":"Gossamer Bio Inc","securities":[{"exchange":"NASDAQ","symbol":"GOSS"}]}],"created":1738585418,"date":"2025-02-03","drug":{"generic":false,"id":"6465f79be0e71d0001be3490","indication_symptom":["Treatment of Pulmonary Arterial Hypertension "],"name":"seralutinib"},"event_type":"Oral presentation","id":"67a0b54adcc94e0001163657","nic_number":"","notes":"","outcome":"Gossamer Bio, Inc presented one oral presentation and three posters related to seralutinib at the Pulmonary Vascular Research Institute (PVRI) 2025 Annual Congress that took place January 29th through February 1st in Rio de Janeiro, Brazil.","outcome_brief":"","source_link":"https://www.benzinga.com/pressreleases/25/02/b43430082/gossamer-bio-presented-clinical-and-preclinical-data-at-the-pulmonary-vascular-research-institute-","source_type":"Press Release","status":"","target_date":"","time":"07:23:38","updated":1738585461},{"commentary":"","companies":[{"cik":"","id":"617b25093abe8b00016c722e","name":"HCW Biologics Inc.","securities":[{"exchange":"NASDAQ","symbol":"HCWB"}]}],"created":1738585174,"date":"2025-02-03","drug":{"generic":false,"id":"67a0b139dcc94e00011634df","indication_symptom":["For alopecia areata"],"name":"HCW9302"},"event_type":"FDA Clearance","id":"67a0b456dcc94e000116361d","nic_number":"","notes":"","outcome":"HCW Biologics Inc announced that it has received clearance of its Investigational New Drug Application (\"IND\") from the U.S. Food and Drug Administration (\"FDA\") to initiate a first-in-human Phase 1 dose escalation clinical trial to evaluate one of its lead drug candidates, HCW9302, 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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.","tag":"p","type":"default"},{"blockName":"core/paragraph","attrs":{"data":[]},"innerBlocks":[],"innerHTML":"\n\u003cp\u003eA 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.\u003c/p\u003e\n","html":"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. 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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. 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.\u003c/span\u003e\u003c/p\u003e\n","answer_link":"https://www.benzinga.com/?post_type=page\u0026p=105610","author":"","created_at":"2021-04-17","style":"default"},{"question_text":"How long does an FDA approval take? ","answer_text":"\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA 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.\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eOnce 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.\u003c/span\u003e\u003c/p\u003e\n","answer_link":"https://www.benzinga.com/?post_type=page\u0026p=105610","author":"","created_at":"2021-04-17","style":"default"},{"question_text":"How do you find FDA approvals?","answer_text":"\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA Catalysts Calendar is one way of tracking all the \u003c/span\u003e\u003cspan style=\"font-weight: 400;\"\u003edecisions 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.\u003c/span\u003e\u003c/p\u003e\n","answer_link":"https://www.benzinga.com/?post_type=page\u0026p=105610","author":"","created_at":"2021-04-17","style":"default"}],"tailwind_layout":false},"align":"","mode":"edit"},"innerBlocks":[],"innerHTML":"","faq":[{"answer_link":"https://www.benzinga.com/?post_type=page\u0026p=105610","author":"","created_at":"2021-04-17","style":"default","question":"What is an FDA PDUFA date?","answer":"\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003ePrescription 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.\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. 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.\u003c/span\u003e\u003c/p\u003e\n"},{"answer_link":"https://www.benzinga.com/?post_type=page\u0026p=105610","author":"","created_at":"2021-04-17","style":"default","question":"How long does an FDA approval take? ","answer":"\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA 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.\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eOnce 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.\u003c/span\u003e\u003c/p\u003e\n"},{"answer_link":"https://www.benzinga.com/?post_type=page\u0026p=105610","author":"","created_at":"2021-04-17","style":"default","question":"How do you find FDA approvals?","answer":"\u003cp\u003e\u003cspan style=\"font-weight: 400;\"\u003eA Catalysts Calendar is one way of tracking all the \u003c/span\u003e\u003cspan style=\"font-weight: 400;\"\u003edecisions in a single place. 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