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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 Biosciences2026-05-28 12:00 ESTFDA / 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

Cogent Biosciences is a precision-oncology company focused on genetically defined cancer targets. Its pipeline is built to address specific kinase-driven cancers with targeted therapy.

Recent company news

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

COGTCogent Biosciences2026-05-27 12:00 EST

Cogent Biosciences Announces Participation in the 2026 Jefferies Global Healthcare Conference

COGTCogent Biosciences2026-05-12 13:30 EST

Cogent Biosciences Announces Multiple Presentations at the European Hematology Association (EHA) 2026 Congress

COGTCogent Biosciences2026-05-05 12:00 EST

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

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