FDA issues second CRL for Replimune's RP1 BLA; company plans layoffs and manufacturing scale-back

Replimune Group, Inc.

FDA second Complete Response Letter for BLA of RP1 plus nivolumab for advanced melanoma; Replimune disagrees with decision.
Without timely accelerated approval, further development of RP1 not viable; company eliminating jobs and scaling back U.S. manufacturing.
IGNYTE trial: 34% response rate, median duration 24.8 months for RP1 plus nivolumab in patients progressing on anti-PD-1.
Company cites inconsistent FDA process: new review team, contradictions from September 2025 Type A meeting, and lack of communication.
Approximately 8,500 advanced melanoma deaths annually in U.S.; CEO says regulatory failure denies patients needed treatment.

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