FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; PDUFA April 10, 2026

Replimune Group, Inc.

FDA accepted resubmission of BLA for RP1 plus nivolumab in advanced melanoma patients who progressed on anti-PD-1 therapy.
PDUFA target action date set for April 10, 2026 under Class II resubmission timeline.
Resubmission addresses the complete response letter received in July 2025; includes additional data and analyses.
Replimune CEO expressed commitment to working closely with FDA to expedite review.

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