Replimune’s investigational melanoma therapy RP1—given with nivolumab—won a favorable reception on an FDA advisory committee vote after earlier negative briefing documents. The company’s BLA submission for the combination in anti–PD-1–refractory advanced melanoma (IGNYTE Phase I/II registrational cohort) has now added another data point to the roller-coaster approval path. The panel outcome matters for investors and trial planners because it signals that at least some FDA external reviewers see enough evidence to advance the regulatory review process. Replimune now needs to translate that committee momentum into a consistent FDA decision on efficacy, durability, and overall benefit-risk for the defined population.