Replimune reported a materially negative quarterly and annual bottom line in Q4 2025 as the company advances RP1 toward potential FDA approval for anti-PD-1 failed melanoma. The BLA was acknowledged by the FDA in early 2025 with priority designation and a PDUFA target date of July 22, 2025, underscoring a pivotal inflection point for commercialization. Ignite 3, the confirmatory trial with overall survival as the primary endpoint, is underway and enrollment in the U.S. is on track with more than 100 sites planned globally, signaling a robust pathway to a potential launch upon approval. The company presented a clear strategic plan to commercialize RP1, including a U.S. manufacturing facility capable of supporting initial demand and long-term supply, a dedicated 60-person commercial organization, and a novel interventional radiology coordination framework to enable image-guided intra-tumoral injections.