Replimune Group (NASDAQ: REPL) stock soared 107.02% during Friday’s regular trading session after a U.S. Food and Drug Administration (FDA) advisory committee voted 10-3 in support of the efficacy data for the company’s melanoma therapy candidate RP1, a rally that appeared to reflect increased investor optimism ahead of the agency’s final review decision.
The stock briefly touched a new 52-week high of $12.50 before ending the session at $11.20. The rally extended into after-hours trading, with shares rising to $11.39, up another 1.70%.
Why Did Replimune Group Stock Surge?
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee concluded that efficacy data from the single-arm IGNYTE study for RP1 (vusolimogene oderparepvec) in combination with nivolumab were evaluable and clinically meaningful for patients with advanced melanoma whose disease had progressed after prior anti-PD-1 therapy. The committee’s vote was advisory and does not bind the FDA, which will make the final decision on the application.
The positive vote came as the FDA reviews Replimune’s resubmitted Biologics License Application (BLA) for RP1. The FDA had raised concerns about the IGNYTE study design, including its response-assessment methodology, the inability to determine RP1’s contribution to the combination treatment, and an overall survival analysis that the agency considered uninterpretable.
Analysts Turn More Bullish on REPL Stock
The regulatory outcome also prompted bullish analyst reactions. Cantor Fitzgerald upgraded Replimune to “Overweight” from “Neutral,” saying the advisory committee vote materially increased the likelihood that Replimune could overcome the issues raised in the FDA’s previous Complete Response Letters and receive accelerated approval around the agency’s Aug. 2 target action date. The firm cited the strength of the committee’s vote as well as testimony from patients and physicians presented during the meeting.
Separately, Wedbush upgraded Replimune to “Outperform” from “Neutral” and increased its price target to $12.00 from $9.00 following the panel’s recommendation.
Wedbush’s more favorable view also reflected Replimune’s account of the earlier FDA review. In particular, Wedbush said Replimune had indicated that the original clinical team supported accelerated approval, identified no conduct or integrity problems, and considered the IGNYTE trial adequate and well controlled, with substantial evidence of effectiveness.
Wedbush interpreted the agency’s decision to accept the BLA for a third review and convene an advisory committee, following the departures of former FDA Commissioner Marty Makary and former Center for Biologics Evaluation and Research Director Vinay Prasad, as a strong indication that the FDA was willing to consider approving RP1.
What’s Next for Replimune Group?
Under the FDA’s Class 1 resubmission process, the agency’s target action date is Aug. 2, 2026. According to Replimune, Chief Executive Officer Sushil Patel said the advisory committee’s decision marked meaningful progress for advanced melanoma patients whose disease had worsened after anti-PD-1 treatment. He added that the company would continue working with the FDA as the agency completes its review ahead of the action date.
RP1 represents Replimune’s leading experimental immunotherapy. Built using a modified herpes simplex virus, it is being investigated together with nivolumab in advanced melanoma.
