FDA accepts Replimune’s melanoma candidate for priority review

22 January 2025

The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma.

Under development at oncolytic immunotherapy company Replimune Group (Nasdaq: REPL), the news sent the firm’s shares up more than 17% to $11.88 by close of trading on Tuesday.

The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. The FDA also informed the company that it is not currently planning to hold an advisory committee meeting in relation to this application, and at this time have not identified any potential review issues. The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma. A confirmatory Phase III trial, IGNYTE-3, is currently underway with over 100 sites planned globally.

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