07:35 AM EDT, 10/20/2025 (MT Newswires) -- Replimune Group ( REPL ) said Monday the US Food and Drug Administration has accepted the resubmission of the Biologics License Application for its lead product candidate, RP1, in combination with nivolumab for the treatment of advanced melanoma, a type of skin cancer, in patients who progress on an anti-PD-1 containing regimen.

The next date set by the FDA is April 10, 2026, based on a Class II resubmission timeline.

Replimune Group ( REPL ) shares were up over 81% in recent premarket activity Monday.

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