Replimune’s Twice‑Rejected Melanoma Drug Prevails in FDA Adcomm Vote on July 31, 2026 Advanced Melanoma Advisory Committees Cellular Tissue gene therapy melanoma drug nivolumab Opdivo Replimune RETINITIS PIGMENTOSA 1 United States Food and Drug Administration vusolimogene oderparepvec +
FDA's re‑evaluation of Capricor and Replimune drugs underscores that review ≠ reversal on July 28, 2026 briefing Capricor Deramiocel concerns Replimune RETINITIS PIGMENTOSA 1 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 +
FDA advisory panels set for Replimune and Capricor in July 2026 on June 29, 2026 advisory meetings advisory panels Capricor Deramiocel July PDUFA Replimune RP1 melanoma 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 +
Replimune Lays Off 60% of Workforce After Second FDA Rejection of RP1 Melanoma Drug on April 21, 2026 layoffs melanoma rejection Replimune RETINITIS PIGMENTOSA 1 United States Food and Drug Administration workforce reduction +
FDA Rejects Replimune's RP1 Melanoma Treatment for Second Time, Citing Unresolved Trial Issues on April 13, 2026 Clinical Trials IGNYTE trial melanoma Oncolytic Viruses rejection Replimune RETINITIS PIGMENTOSA 1 United States Food and Drug Administration vusolimogene oderparepvec +
Replimune Resubmits Melanoma Drug for FDA Approval After Initial Rejection on October 21, 2025 Approved melanoma Replimune resubmission RETINITIS PIGMENTOSA 1 United States Food and Drug Administration +
Scientists Protest FDA's Rejection of Replimune’s Tumor Destroying Therapy on August 05, 2025 Clinical Trials Drug Approval Heterogeneity IGYNTE melanoma oncolytic immunotherapy rejection Replimune RETINITIS PIGMENTOSA 1 scientist protest United States Food and Drug Administration +
Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy on August 04, 2025 Advanced Melanoma Cancer Therapeutic Procedure Complete IGNYTE trial nivolumab Replimune Response Letter RETINITIS PIGMENTOSA 1 United States Food and Drug Administration vusolimogene oderparepvec +
Replimune's Shares Plunge After FDA Rejects Melanoma Drug Application on July 22, 2025 Antineoplastic Agents Clinical Trial Design Complete Drops - Drug Form Frequency of Responses melanoma Prices rejection Replimune Response Letter RETINITIS PIGMENTOSA 1 United States Food and Drug Administration +