08:36 AM EDT, 06/26/2026 (MT Newswires) -- Replimune Group ( REPL ) said Friday that the US Food and Drug Administration has accepted its resubmitted biologics license application for RP1 (vusolimogene oderparepvec) in combination with nivolumab to treat advanced melanoma.
The FDA assigned a target action date of Aug. 2 and is expected to convene an advisory committee meeting in late July, the company said.
The application seeks accelerated approval based on data from the IGNYTE trial in patients with advanced melanoma who progressed on anti-PD-1 therapy, the company said.