09:25 AM EST, 01/21/2025 (MT Newswires) -- Replimune Group ( REPL ) said Tuesday the US Food and Drug Administration has accepted its Biologics License Application for RP1, or vusolimogene oderparepvec, in combination with nivolumab for advanced melanoma, granting Priority Review with a decision expected by July 22.

The company said the application is supported by data from the IGNYTE trial, which evaluated RP1 in patients whose melanoma progressed after anti-PD-1 therapy.

A phase 3 confirmatory trial, IGNYTE-3, is ongoing with global enrollment, Replimune ( REPL ) added.

Shares of the company were up around 27% in recent Tuesday premarket activity.