Cogent Biosciences (COGT) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for bezuclastinib in NonAdvanced Systemic Mastocytosis patients previously treated with avapritinib as well as in patients with Smoldering Systemic Mastocytosis; populations with no currently approved standard of care. The Breakthrough Therapy Designation is based on positive results from the registration-directed SUMMIT trial in which bezuclastinib achieved statistical significance across all primary and key secondary endpoints in patients with NonAdvSM, including the consistent benefit observed in populations with high unmet need. Top-line data were announced in July 2025, and additional data are expected to be presented at an upcoming scientific conference.
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