Replimune gets FDA review for melanoma drug after prior setbacks

29 June 2026

Replimune (Nasdaq: REPL) has gained another chance to secure accelerated approval for its lead melanoma candidate RP1, after the US Food and Drug Administration accepted a resubmitted biologics license application.

The Woburn, Massachusetts-based biotech said the FDA had accepted the resubmission of RP1 (vusolimogene oderparepvec), in combination with Bristol Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), for the treatment of advanced melanoma.

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