Summit Therapeutics Outlines FDA PDUFA Date for Ivonescimab BLA on November 14 and Plans HARMONi-3 PFS in Late 2026
Summit Therapeutics (NASDAQ:SMMT) announced that the U.S. Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of November 14 for its Biologics License Application (BLA) for ivonescimab, indicating an expected decision by year-end. The company also plans to initiate the HARMONi-3 progression-free survival trial in the second half of 2026.
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Topics: blending application (BLA) clinical development commercialization plans management commentary