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's decision follows a resubmitted Biologics License Application (BLA) for the drug, which is intended for patients whose melanoma has progressed after anti-PD-1 treatment. Despite previous rejections from the FDA, the committee members largely agreed that the efficacy results from the IGNYTE trial were evaluable and clinically meaningful. While FDA staff reviewers initially expressed concerns regarding the trial's design and the ability to distinguish the impact of RP1 from systemic therapies, the majority of the panel supported the accelerated approval. This positive outcome prompted Cantor Fitzgerald to upgrade the stock to 'Overweight' from 'Neutral,' with the stock surging 140% in pre-market trading. The FDA is expected to provide its official decision on the drug's application on Aug. 2, 2026.