Replimune Group Inc shares surged 127% following a favorable FDA advisory panel vote for its experimental therapy RP1.
Replimune Group Inc shares experienced a significant 127% price surge following an independent FDA advisory panel vote that endorsed the clinical significance of its experimental therapy, RP1. The panel voted 10 to 3 in favor of the drug, which is designed to treat advanced melanoma patients who have not responded to prior anti-PD-1 treatments. This endorsement marks a major milestone for the company, which previously faced a rejection from the FDA in June 2025. The agency's staff noted that the previous mid-stage study was not interpretable, but the new panel discussion highlighted the potential effectiveness and durability of RP1. The therapy utilizes a genetically modified herpes simplex virus to attack tumor cells while enhancing the immune response against cancer. While the stock price rose sharply, analysts note that Replimune Group Inc remains unprofitable and faces challenges in profitability and growth. Investors are advised to be cautious as the company's GF Score of 27/100 reflects ongoing financial weaknesses despite the positive regulatory progress.