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
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