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Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

Cogent Biosciences (COGT)Cogent BiosciencesFDA / regulatory

NDA supported by positive results from the APEX pivotal trial demonstrating clinically meaningful responses and evidence of disease modification in patients with AdvSM PDUFA target action date set for June 29, 2027 WALTHAM, Mass. and BOULDER, Colo., Sept.

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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

COGTCogent Biosciences2026-09-15 12:00 EST

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) for Bezuclastinib in Patients with Advanced Systemic Mastocytosis (AdvSM)

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)

COGTCogent Biosciences2026-06-12 12:01 EST

Cogent Biosciences Announces Preclinical Data from Novel JAK2 V617F Inhibitor at the 2026 European Hematology Association (EHA) Congress

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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5.6B USD
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