Cogent Biosciences Submits New Drug Application for Bezuclastinib in Nonadvanced Systemic Mastocytosis

Reuters

Feb 10

<a href="https://laohu8.com/S/COGT">Cogent Biosciences</a> Submits New Drug Application for Bezuclastinib in Nonadvanced Systemic Mastocytosis

Cogent Biosciences Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for bezuclastinib in the treatment of nonadvanced systemic mastocytosis (NonAdvSM). The submission, announced in December 2025, is based on positive clinical data from the SUMMIT pivotal trial and follows the Breakthrough Therapy Designation previously granted for bezuclastinib in patients with SSM and NonAdvSM who have received prior avapritinib.

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 on February 10, 2026, and is solely responsible for the information contained therein.

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The submission, announced in December 2025, is based on positive clinical data from the SUMMIT pivotal trial and follows the Breakthrough Therapy Designation previously granted for bezuclastinib in patients with SSM and NonAdvSM who have received prior avapritinib.Disclaimer: This news brief was created by Public Technologies  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. 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The submission, announced in December 2025, is based on positive clinical data from the SUMMIT pivotal trial and follows the Breakthrough Therapy Designation previously granted for bezuclastinib in patients with SSM and NonAdvSM who have received prior avapritinib.\n      \n\n\nDisclaimer: 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. 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