Cogent's Bezuclastinib NDA Accepted For Advanced Systemic Mastocytosis; PDUFA Set For June 2027
Cogent Biosciences (COGT) announced FDA acceptance of its NDA for Bezuclastinib to treat Advanced Systemic Mastocytosis, with a PDUFA target date of June 2027. The NDA is supported by APEX trial data showing a 65% overall response rate and 79% 12-month progression-free survival. The FDA has not identified any review issues. COGT is also advancing NDAs for other indications. The stock is currently trading at $33.49, up 0.24%.


