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Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)

Cogent Biosciences (COGT)Cogent BiosciencesClinical readout

Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated safety profile for AdvSM patients APEX NDA is third submission for bezuclastinib in six months; PEAK

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Cogent Biosciences

Genetically Defined Diseases Cogent Biosciences develops precision therapies for diseases driven by defined oncogenic mutations. Its portfolio is led by a selective KIT inhibitor and includes earlier programs directed at ErbB2, PI3Kα, KRAS and JAK2. Bezuclastinib Bezuclastinib is designed to inhibit KIT D816V and other exon 17 KIT...

Recent company news

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COGTCogent Biosciences2026-08-10 12:00 EST

Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2026 Financial Results

COGTCogent Biosciences2026-06-30 12:00 EST

Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)

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COGTCogent Biosciences2026-06-12 12:00 EST

Cogent Biosciences Announces Detailed Data from APEX Pivotal Trial of Bezuclastinib in Patients with Advanced Systemic Mastocytosis at the 2026 European Hematology Association (EHA) Congress

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