Replimune announced that the FDA accepted a resubmitted biologics license application for RP1, an oncolytic HSV‑based therapy given with PD‑1 blockade, setting a new decision date in April 2026. The company added data, analyses and context the agency requested after a prior rejection citing heterogeneity in the pivotal dataset. Replimune’s CEO committed to close cooperation with the agency and characterized the resubmission as materially strengthened by additional analyses. The acceptance triggered a strong market reaction, with the company’s stock jumping on the news. The decision to press forward reflects a broader regulator‑industry dialogue on interpreting early‑phase immunotherapy datasets for approvals.