Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for NonAdvanced Systemic Mastocytosis

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…

ByRidhi RastogiDecember 31, 2025

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Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Shots: Cogent Biosciences has reported the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx. in pts with imatinib-resistant or intolerant GIST; the US FDA’s NDA filing is planned for H1’26 As of Sep 30, 2025, trial met its 1EP of improved PFS (mPFS: 16.5 vs 9.2mos.) & showed ORR of 46% vs…

ByRidhi RastogiNovember 11, 2025

Cogent Biosciences Reports US FDA’s NDA Submission of Bezuclastinib for NonAdvanced Systemic Mastocytosis

Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

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