Shots:
- The US FDA has received the NDA of bezuclastinib for the treatment of NonAdvanced Systemic Mastocytosis (NonAdvSM)
- NDA was supported by the SUMMIT trial, which met its 1 & 2EPs, showing clinical benefit across all symptom domains, incl. 11 individual patient-reported symptoms as well as the most severe symptom, along with correlated biomarker reductions as reported in Jul 2025. Updated data showed sustained, deepening clinical benefit through 48wks.
- The company is planning for additional NDA submissions for Gastrointestinal Stromal Tumors & Advanced Systemic Mastocytosis in H1’26, supported by favorable PEAK & APEX trial reported in Q4’25
Ref: Cogent | Image: Cogent | Press Release
Related News: Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)
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