Cogent Biosciences Gets US FDA Acceptance for Bezuclastinib AdvSM Application

09:20 AM EDT, 09/15/2026 (MT Newswires) -- Cogent Biosciences (COGT) said Tuesday that the US Food and Drug Administration has accepted its New Drug Application for bezuclastinib in patients with advanced systemic mastocytosis and set a Prescription Drug User Fee Act target action date of June 29, 2027. The NDA is supported by data from the pivotal APEX trial, which showed a 65% overall response rate and an 81% response rate under pure pathological response criteria, the company said. The 12-month progression-free and overall survival rates were 79% and 87%, respectively, Cogent said. Cogent also has NDAs for bezuclastinib in nonadvanced systemic mastocytosis and GIST under FDA review, it said.