FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; decision by Aug 2

Replimune Group, Inc.

FDA accepted as complete, class 1 response; PDUFA goal date August 2, 2026.
Advisory committee meeting expected in late July 2026.
Resubmission based on Phase 2 IGNYTE trial data for RP1 + nivolumab in anti-PD-1 progressed patients.
RP1 (vusolimogene oderparepvec) seeks accelerated approval for advanced melanoma.
CEO notes FDA urgency reflecting significant unmet need and community support.

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