Shots:
- The US FDA has accepted the NDA of bezuclastinib for the treatment of NonAdvSM, with no advisory committee meeting planned or review issues identified yet (PDUFA: Dec 30, 2026)
- NDA was backed by SUMMIT trial, which met its 1 & 2EPs, showing sustained, deepening clinical benefit through 48wks., plus impact on bone mineral density & evidence of disease modification, with effect also observed in pts with high unmet need
- The company is planning to complete bezuclastinib NDA submission for patients with Gastrointestinal Stromal Tumors who have received prior treatment with imatinib in Apr 2026 & for AdvSM in H1’26
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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