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 vote 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 by the FDA, the panel concluded that the efficacy results from the IGNYTE trial were evaluable and clinically meaningful. This positive outcome prompted Cantor Fitzgerald to upgrade the company's stock to 'Overweight' from 'Neutral'. The company's stock surged 140% in pre-market trading, reflecting a bullish sentiment among investors. While the FDA's official decision is expected on August 2, 2026, the committee's support is seen as a significant milestone. The drug's future was closely watched because the company had previously faced challenges regarding the evidence provided for RP1's benefits. However, the panel's support, bolstered by testimony from patients and physicians, strengthens the case for accelerated approval.