Replimune won FDA accelerated approval for its oncolytic viral therapy Tudriqev (formerly RP1) for advanced melanoma, ending a two-rejection saga for the company. The FDA cleared Tudriqev in combination with Bristol Myers Squibb’s Opdivo (nivolumab), following an advisory committee vote that backed the efficacy signal in a difficult-to-treat population after PD-1 therapy failure. The approval is conditional: it remains tied to confirmatory evidence from an ongoing Phase 3 trial designed to test Tudriqev plus Opdivo against PD-1 regimens and/or chemotherapy. Replimune’s earlier Phase 1/2 single-arm data showed tumor responses in roughly a quarter of enrolled patients, with a median duration a bit over 14 months, according to the reporting. For investors and partners, the milestone shifts Tudriqev’s regulatory risk profile from persistent rejection to a clear path toward label expansion depending on confirmatory outcomes expected in late 2027. For clinicians, it adds another intratumoral option in the post–checkpoint-inhibitor melanoma setting.