Replimune is lining up a new U.S. Food and Drug Administration resubmission for its advanced melanoma drug RP-1 after reaching alignment with the agency, following two prior rejections. The company said the FDA pledged to treat the resubmitted biologics license application as an urgent matter upon receipt and to prioritize review. RP-1 (vusolimogene oderparepvec) is being pursued in combination with nivolumab for advanced melanoma. The company’s announcement follows a short interval after a second complete response letter, with the company saying it has new discussions with the FDA following leadership changes within FDA’s oncology and biologics review structures. For sponsors, this marks a high-stakes attempt to convert regulatory feedback into a revised dataset package. If the resubmission advances quickly, it may also shift competitive dynamics in melanoma immunotherapy strategies that increasingly rely on combination endpoints and durable response measures.