The U.S. Food and Drug Administration accepted Replimune’s resubmitted biologics license application for RP1, an oncolytic herpesvirus engineered to prime immune responses, and set a target decision date of April 10, 2026. Replimune added new analyses and data to address prior FDA concerns about heterogeneity in the pivotal dataset; the company said it will work closely with the agency to expedite review. Replimune’s resubmission centers on RP1 combined with PD-1 blockade for advanced melanoma after progression on PD-1 therapy. CEO Sushil Patel said the combination offers a “strong risk‑benefit profile where there are few options,” and the market reacted: Replimune shares jumped sharply on the acceptance. The FDA’s renewed review underscores regulators’ willingness to reassess oncolytic and viral‑based immunotherapies when sponsors supplement clinical datasets and analyses.