Cogent Biosciences Announces FDA Breakthrough Therapy Designation for Bezuclastinib

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.