Replimune’s oncolytic virus Tudriqev (formerly RP1) cleared the FDA on an accelerated approval pathway for advanced melanoma, ending a back-and-forth that included two prior FDA rejections. The FDA approval covers Tudriqev given alongside Bristol Myers Squibb’s Opdivo for patients whose disease has progressed after PD-1–blocking therapy. The regulator’s decision followed an advisory committee vote in support of the program, despite continuing FDA staff concerns about trial design and response interpretation. The decision hinges on single-arm trial evidence in a population with limited options, with confirmation expected from a Phase 3 study running through late 2027. For Replimune, the approval is also a commercial re-rating after Tumor response signals were repeatedly challenged during FDA review. Analysts cited in the coverage pointed to substantial peak-sales potential, underscoring how quickly the market narrative can flip when accelerated approval lands.