Cogent Biosciences Announces FDA Breakthrough Therapy Designation for Bezuclastinib
Cogent Biosciences, Inc. (COGT)
Last cogent biosciences, inc. earnings: 11/8 04:05 pm
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Source: GlobeNewswire
Detailed results from bezuclastinib’s positive SUMMIT trial evaluating bezuclastinib in patients with NonAdvanced Systemic Mastocytosis planned for presentation at upcoming scientific conference this yearNDA submission for bezuclastinib planned by YE 2025 WALTHAM, Mass. and BOULDER, Colo., Oct. 20, 2025 (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 granted Breakthrough Therapy Designation for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients previously treated with avapritinib as well as in patients with Smoldering Systemic Mastocytosis; populations with no currently approved standard of care. “We are excited to announce Breakthrough Therapy Designation for bezuclastinib, which highlights the FDA’s recognition of the unmet need for patients with NonAdvanced Systemtic Mastocytosis
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COGT
Sec Filings
- 11/18/25 - Form 8-K
- 11/17/25 - Form SCHEDULE
- 11/14/25 - Form SCHEDULE
- COGT's page on the SEC website