FDA Accepts NDA for Cogent Biosciences' Bezuclastinib Combination in GIST Under RTOR Program

Reuters

Jan 20

FDA Accepts NDA for <a href="https://laohu8.com/S/COGT">Cogent Biosciences</a>' Bezuclastinib Combination in GIST Under RTOR Program

Cogent Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has agreed to accept its New Drug Application (NDA) for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors (GIST) who have previously received imatinib. The application will be reviewed under the FDA's Real-Time Oncology Review (RTOR) program, which allows pre-submission of NDA components for earlier review of clinical trial data. Cogent is expected to initiate the RTOR process immediately, with completion of the NDA submission anticipated in April 2026. Full results from the PEAK trial supporting the application will be presented in the first half of 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cogent Biosciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9628197) on January 20, 2026, and is solely responsible for the information contained therein.

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The application will be reviewed under the FDA's Real-Time Oncology Review (RTOR) program, which allows pre-submission of NDA components for earlier review of clinical trial data. Cogent is expected to initiate the RTOR process immediately, with completion of the NDA submission anticipated in April 2026. Full results from the PEAK trial supporting the application will be presented in the first half of 2026.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cogent Biosciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9628197) on January 20, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"SG9999014021.USD","symbol_name":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260120:nNDLb0t964:1","article_id":"2604050113","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2604050113","pubTimestamp":1768914389,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Cogent Biosciences Inc. announced that the U.S. Food and Drug Administration  has agreed to accept its New Drug Application  for bezuclastinib in combination with sunitinib for patients with Gastrointestinal Stromal Tumors  who have previously received imatinib. 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