The FDA accepted Summit Therapeutics’ marketing application for ivonescimab, a PD‑1/VEGF bispecific antibody, and set a PDUFA decision date in November. Summit said regulators acknowledged its submission package and assigned a target action date, moving the candidate closer to a potential U.S. approval. Ivonescimab combines immune checkpoint blockade with angiogenesis blockade in a single molecule; bispecific antibodies simultaneously bind two targets and can combine mechanisms in one therapeutic. The accepted filing marks a material regulatory milestone for Summit’s next‑generation immuno‑oncology strategy.