Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GIST
The NDA for a new drug has been accepted for review with Priority Review, further highlighting its significance after previously being designated as Breakthrough Therapy and undergoing Real-Time Oncology Review post successful Phase 3 PEAK trials. The PDUFA date has been scheduled for November 30, 2026.