Cogent Biosciences Announces FDA Acceptance of New Drug Application for Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)
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., March 16, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for bezuclastinib in patients with NonAdvanced Systemic Mastocytosis (NonAdvSM) and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2026. In addition, the FDA communicated that at this time, there is no plan to hold an advisory committee, nor have they identified any potential review issues.Clinical results from the pivotal SUMMIT trial with bezuclastinib in NonAdvSM patients demonstrated clinically meaningful and highly statistically significant improvements across the primary and all key secondary endpoints. Data from the SUMMIT trial through 48 weeks showcased a clear and continued deepening of symptomatic improvement over time,
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COGT
Sec Filings
- 2/17/26 - Form SCHEDULE
- 2/17/26 - Form S-8
- 2/17/26 - Form SCHEDULE
- COGT's page on the SEC website