Replimune Group received a favorable 10-3 advisory committee vote for its melanoma therapy RP1.
Replimune Group received a favorable 10-3 advisory committee vote from the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee regarding its melanoma therapy RP1. The committee reviewed the drug's resubmitted Biologics License Application (BLA) for use in patients whose melanoma had progressed after anti-PD-1 treatment. Despite previous rejections from the FDA, the majority of the panel voted that the efficacy results from the IGNYTE trial were evaluable and clinically meaningful. This positive outcome prompted Cantor Fitzgerald to upgrade Replimune Group's stock to 'Overweight' from 'Neutral', causing the stock to surge 140% in pre-market trading. While FDA staff reviewers initially expressed concerns regarding the trial's design and the ability to distinguish the impact of RP1 from systemic therapy, many study investigators and patients testified in favor of the communication. The FDA is expected to provide its official decision on the drug's application on August 2, 2026.