Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for Advanced Systemic Mastocytosis (AdvSM)

Shots: The US FDA has accepted an NDA for bezuclastinib in pts with AdvSM, plus set a PDUFA target action date of Jun 29, 2027, with no plans to hold an advisory committee, as well as no potential review issues identified NDA was backed by the APEX trial, which showed as of Mar 31, 2026, a 65% ORR by mIWG-MRT-ECNM criteria, incl. 57% achieving CR, CRh or PR as best response; the PPR response rate was 81%, while 12mos. PFS & OS rates were 79% & 87%, respectively, with mPFS & mOS not yet mature Bezuclastinib’s NDA for non-advanced systemic mastocytosis is under FDA review with a PDUFA target action date of Dec 30, 2026, while the NDA for gastrointestinal stromal tumors has a PDUFA target action date of Nov 30, 2026 Ref: Globenewswire  |  Image: Cogent Biosciences  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for Advanced Systemic Mastocytosis (AdvSM) appeared first on PharmaShots.