Replimune bounces back on FDA acceptance of BLA

21 October 2025

Oncolytic immunotherapies specialist Replimune Group (Nasdaq: REPL) has announced that the US Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.

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

Shares in Replimune nearly doubled Monday following the announcement of the news.

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