Replimune resubmitted its biologics license application for RP1, an engineered oncolytic herpes simplex virus given with PD‑1 blockade, and the FDA has accepted the filing and set a target decision date for April 10, 2026. The company added new analyses and data after the agency previously cited trial heterogeneity in a July rejection. Market reaction was immediate: Replimune shares rose sharply after the agency confirmed acceptance. CEO Sushil Patel said the company will work with the FDA to expedite review and reiterated RP1’s potential in advanced melanoma refractory to PD‑1 therapy. The resubmission shifts the program back into a regulatory timeline; oncology investors and competitors will watch the FDA’s questions around trial interpretability, patient heterogeneity and confirmatory evidence.