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FDA Accepts Cogent Biosciences' NDA For Bezuclastinib In Patients With Advanced Systemic Mastocytosis

Benzinga·09/15/2026 12:02:57
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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