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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)investors.cogentbio.com2026-05-28 20:03 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 is a biopharmaceutical company focused on pipeline execution and catalyst-driven growth, with investors tracking how data, regulatory milestones, and launch timing reshape the investment case.

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