Replimune announced that the U.S. FDA has accepted its resubmitted biologics license application for RP1 in advanced melanoma and set a target decision date of April 10, 2026. The filing adds analyses and data intended to address the agency’s prior concerns about interpretability and patient heterogeneity from an earlier rejection. The acceptance sent Replimune’s stock sharply higher and reopens the regulatory pathway for an oncolytic virus therapy combined with checkpoint inhibitors. Company executives said they will work closely with the agency to expedite review and stressed the unmet need in PD-1–refractory melanoma.