The FDA accepted Summit Therapeutics’ BLA/MAA for ivonescimab, a PD‑1/VEGF bispecific antibody for non‑small cell lung cancer, and set a PDUFA decision date in November. Summit reported the filing acceptance and said regulators will render a decision by the scheduled date, advancing the company’s program toward potential approval. Summit positioned ivonescimab as a next‑generation immuno‑oncology agent that targets immune checkpoint and angiogenesis pathways simultaneously. Acceptance follows submission of pivotal data packages and will trigger an agency review clock and possible advisory committee interactions depending on FDA questions. Summit’s timeline sets up a late‑year regulatory inflection point for the company and for bispecific immunotherapy approaches. Investors and competitors will watch readouts and regulatory dialogue closely to assess ivonescimab’s positioning versus existing PD‑1 and VEGF-targeting regimens.