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Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

Cogent Biosciences (COGT)Cogent BiosciencesFDA / regulatory

NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026 Bezuclastinib combination is first treatment ever to demonstrate statistically significant

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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 Biosciences2026-06-30 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

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COGTCogent Biosciences2026-05-30 12:00 EST

Cogent Biosciences Announces Detailed Clinical Data from PEAK Phase 3 Trial with Bezuclastinib in Combination with Sunitinib in Gastrointestinal Stromal Tumors (GIST) at 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

COGTCogent Biosciences2026-05-28 12:00 EST

Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST

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