Replimune resubmitted its biologics license application for RP1, an engineered oncolytic herpesvirus given with checkpoint inhibition, and the FDA accepted the filing — triggering a near-doubling of the company’s shares. Management said it supplied additional data and analyses intended to address the agency’s prior concerns about trial heterogeneity. CEO Sushil Patel framed the package as clarifying RP1’s risk‑benefit in PD‑1 refractory advanced melanoma and urged expedited review. Investors and clinicians will be watching the agency’s review timeline and any requested advisory interactions; an approval would position RP1 as an option for patients who have progressed on PD‑1 therapy.