05:04 PM EST, 11/21/2024 (MT Newswires) -- Replimune Group ( REPL ) said late Thursday it has filed a biologics license application with the US Food and Drug Administration for RP1 plus nivolumab to treat adults with advanced melanoma who were previously given an anti-PD1 containing regimen.

The filing was made under the accelerated approval pathway, the company said, adding the regulator has given breakthrough therapy designation to RP1 plus nivolumab in the same setting.

Replimune ( REPL ) shares were rising nearly 19% in recent after-hours trading.

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