Replimune resubmitted its biologics license application for RP1, an engineered oncolytic herpes simplex virus combined with PD-1 blockade, and the FDA has accepted the filing with a target decision date of April 10, 2026. The company added analyses and data after a July rejection that cited heterogeneity in the pivotal trial. Replimune highlighted objective response data (32.9% ORR in a phase 1/2 cohort) and said it will work closely with regulators to expedite review. The announcement triggered a sharp positive market reaction and renewed investor scrutiny of oncolytic-immunotherapy combinations.