Cogent Biosciences (COGT) announced positive top-line results from the registration-directed APEX Part 2 clinical trial of bezuclastinib in patients with advanced systemic mastocytosis demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response. This is the third positive pivotal trial result for bezuclastinib in 2025, following positive announcements from the SUMMIT trial in NonAdvSM patients and the PEAK trial in GIST patients earlier this year. Based on these top-line data, Cogent expects to submit a new drug application, NDA, to the U.S. Food and Drug Administration, FDA, for bezuclastinib in AdvSM during the first half of 2026. In addition, Cogent plans to present detailed data from the APEX trial at an upcoming scientific meeting in the first half of 2026.
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