NasdaqGM:SMMTBiotechs
Summit Therapeutics (SMMT) Is Up 6.5% After FDA Accepts Ivonescimab BLA With 2026 PDUFA Date
Summit Therapeutics Inc. previously announced that the FDA accepted for filing its Biologics License Application for ivonescimab plus chemotherapy in EGFR‑mutated, locally advanced or metastatic non-squamous NSCLC after tyrosine kinase inhibitor therapy, assigning a PDUFA action date of November 14, 2026.
Beyond this U.S. filing, Summit and partner Akeso have broadened ivonescimab’s late-stage program across multiple Phase III trials and tumor types, underscoring a concerted push to position...