FDA files show lingering concerns and split views over Replimune’s melanoma drug on September 03, 2026 Accelerated Approved IGNYTE In complete remission melanoma nivolumab Opdivo Replimune RETINITIS PIGMENTOSA 1 single-arm trial United States Food and Drug Administration +
FDA Staff Signal Replimune RP1 Melanoma Trial Failure, Slashing Stock on July 28, 2026 Blackfoot language Drops - Drug Form Effectiveness IGNYTE melanoma rejection Replimune RETINITIS PIGMENTOSA 1 trial failure United States Food and Drug Administration +
Replimune to ask FDA for re‑review of melanoma drug, as agency stands by past rejections on May 29, 2026 Accelerated Advanced Melanoma Approved Complete Response Letter IGNYTE melanoma drug nivolumab Opdivo Replimune RETINITIS PIGMENTOSA 1 United States Food and Drug Administration vusolimogene oderparepvec +