ODINSIGNAL JOURNAL · NEWS & EVENTS
Summit Therapeutics’ ivonescimab receives FDA PDUFA goal date of Nov 14 2026
Summit Therapeutics’ ivonescimab (HARMONi) BLA has a FDA PDUFA goal action date of November 14 2026 for non‑small cell lung cancer.
Summit Therapeutics’ Phase 3 candidate ivonescimab (HARMONi), being studied with chemotherapy for non‑small cell lung cancer, has been assigned a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. The FDA provided this target date in its PDUFA calendar Biopharma Transcript. The date represents a regulatory review milestone, not a guaranteed decision deadline; the agency may act earlier, later, or request additional information. Market participants will resolve the binary market on OdinSignal as Yes if approval is granted on or before the target date, and No otherwise.
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