Cogent Biosciences Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM). The submission follows the FDA’s granting of Breakthrough Therapy Designation to bezuclastinib in October 2025, highlighting its potential to address significant unmet medical needs. The NDA is supported by positive clinical data from the SUMMIT pivotal trial, which demonstrated statistical significance across all primary and key secondary endpoints. Additional NDA submissions for bezuclastinib in Gastrointestinal Stromal Tumors (GIST) and Advanced Systemic Mastocytosis (AdvSM) are expected 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: 9618182) on December 30, 2025, and is solely responsible for the information contained therein.