Replimune, Inc. · complete response letter (BL 125827)

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i Lk Fy" U.S. FOOD & DRUG ADMINISTRATION Our STN: BL 125827 COMPLETE RESPONSE APRIL 10, 2026 Replimune, Inc. Attention: Kari Jeschke 500 Unicorn Park Drive Woburn, MA 01801 Dear Kari Jeschke: Please refer to your Biologics License Application (BLA) received (1b) (4) ; ‘or vusolimogene oderparepvec, submitted under section 351(a) of the Public Health Service Act. We acknowledge receipt of your amendment dated October 9, 2025, which constituted a complete response to our July 21, 2025, action letter. We have completed a comprehensive review of all the submissions relating to this BLA ‘or vusolimogene oderparepvec in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-bl

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