Replimune said the FDA has accepted its resubmitted biologics license application for RP1, an oncolytic herpes‑based therapy combined with PD‑1 blockade, and set a target decision date of April 10, 2026. The company added new data and analyses after the agency rejected an earlier submission in July citing interpretability concerns tied to patient heterogeneity. Replimune reported the resubmission includes additional information from completed clinical trials and pledged to work closely with the agency to expedite review. The market reaction was immediate: the company’s shares surged nearly 100% on the news. A favorable outcome could revalidate engineered oncolytic virus strategies and revive investor interest in virotherapy combinations; a rejection would raise questions about acceptable evidence standards for single‑arm immuno‑oncology datasets.