REPL Stock Plunges 54% in 3 Months After FDA Rejects Skin Cancer Drug

Core Insights - Replimune Group's share price has decreased by 54.2% over the past three months following the FDA's complete response letter (CRL) regarding its biologics license application (BLA) for RP1 in combination with Opdivo for advanced melanoma treatment [1][5] - The FDA's CRL was based on the inadequacy of data from the IGNYTE study, which did not meet the standards for a well-controlled clinical investigation, although no safety concerns were raised [2][5] - The setback has created significant uncertainty regarding the regulatory path for RP1, delaying Replimune's prospects of launching its first approved product and establishing a revenue stream [3][4] Company Developments - Replimune has completed a Type A meeting with the FDA to discuss the CRL and is currently reviewing the agency's feedback to determine next steps, although a clear regulatory path remains uncertain [6][7] - The BLA for RP1 in combination with Opdivo was initially accepted for review under the FDA's Priority Review pathway in January 2025, based on the IGNYTE study's primary analysis data [8] - Replimune is also exploring RP1 for other indications, including non-melanoma skin cancers and as a monotherapy for solid organ transplant recipients with skin cancers [11] Market Context - Year-to-date, Replimune's shares have fallen by 64.2%, contrasting with a 3.6% growth in the broader industry [4] - The company is facing challenges in delivering on its lead program, which has raised broader investor concerns about its future performance [3]