Cogent Biosciences Announces Submission of New Drug Application for Bezuclastinib in NonAdvanced Systemic Mastocytosis
Cogent Biosciences, Inc. (COGT)
Last cogent biosciences, inc. earnings: 11/8 04:05 pm
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Source: GlobeNewswire
WALTHAM, Mass. and BOULDER, Colo., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM). The submission is based on positive clinical data from the SUMMIT pivotal trial and follows the Breakthrough Therapy Designation for bezuclastinib in patients with SSM and patients with NonAdvSM who have received prior avapritinib. “This NDA is the first of three planned submissions for bezuclastinib based on positive clinical data from three pivotal trials completed in 2025 for patients with systemic mastocytosis and GIST. Building on the exceptional results from the SUMMIT trial, this filing moves us closer to delivering an important disease-modifying therapy to patients with NonAdvSM,” said Andrew
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- Cogent Biosciences (NASDAQ:COGT) had its "buy" rating reaffirmed by analysts at Jefferies Financial Group Inc..MarketBeat
COGT
Sec Filings
- 12/30/25 - Form 4
- 12/30/25 - Form 4
- 12/30/25 - Form 4
- COGT's page on the SEC website