REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA

Core Viewpoint - Replimune Group, Inc. has received FDA acceptance for its biologics license application for RP1 in combination with Opdivo to treat advanced melanoma, with a decision expected by July 22, 2025 [1][2]. Company Developments - The FDA has granted a priority review for the BLA and has not identified any potential review issues, indicating a smooth review process [2][5]. - Replimune's shares increased by 16.9% following the announcement, and the company has seen a 50.7% increase in share price over the past year, contrasting with a 14.8% decline in the industry [1][2]. - The BLA submission was based on data from the IGNYTE study, which assessed RP1 combined with Opdivo for patients with anti-PD-1 failed melanoma [3][4]. - The ongoing confirmatory phase III IGNYTE-3 study is evaluating the RP1/Opdivo combination for advanced melanoma patients who have progressed on anti-PD-1 and anti-CTLA-4 therapies [4][6]. Product Pipeline - RP1 has received Breakthrough Therapy designation for treating advanced melanoma patients who have previously received anti-PD-1 therapy [5]. - In addition to melanoma, Replimune is exploring the RP1/Opdivo combination for non-melanoma skin cancer indications and evaluating RP1 as a monotherapy for solid organ transplant recipients with skin cancers [6]. Market Position - Replimune currently has no approved products, making the successful development of RP1 and other pipeline candidates critical for the company's future [6].