FDA Leadership Overrules Staff Concerns To Grant Replimune Accelerated Approval For Tudriqev

Replimune Group Inc. (REPL) announced the U.S. commercial launch of TUDRIQEV, a melanoma therapy for advanced cutaneous melanoma patients who progressed on PD-1-blocking treatments. The FDA granted accelerated approval based on a 24.2% objective response rate in trials. The company estimates 105,000 new U.S. melanoma cases in 2025. Continued approval depends on confirmatory trial results.

Replimune Group, Inc. (REPL) has begun U.S. sales of TUDRIQEV for advanced melanoma patients after PD-1 therapy, under accelerated approval. This marks the company's first commercial launch, transitioning from clinical-stage to revenue generation. Successful adoption could drive significant revenue growth, according to the company.

Replimune Group, Inc. (REPL) announced that TUDRIQEV™, a treatment for advanced melanoma, is now available in the U.S. The therapy, approved under accelerated approval, is indicated for adult patients who have progressed with PD-1-blocking antibody regimens. TUDRIQEV achieved a 24.2% objective response rate in clinical trials, with a median duration of 14.1 months. The company also launched a patient support program to assist with access and reimbursement.

Replimune's recent approval for Tudriqev, a melanoma immunotherapy, may signal a shift in early-stage cancer treatment. Experts highlight the potential of locally delivered therapies, with BMO Capital Markets estimating $1.3B annual sales for Tudriqev by 2035. Companies like Surge Therapeutics, Johnson & Johnson, and Ankyra Therapeutics are advancing similar treatments, aiming to improve efficacy and reduce toxicity.

The FDA approved 13 drugs in August 2026, including Moderna's mFLUSIVA ($149.56/dose) for influenza prevention, Takeda's Orezyful for narcolepsy, Replimune's Tudriqev ($450,000/course) for melanoma, Bristol-Myers Squibb's Zenbexus ($29,500/28-day cycle) for multiple myeloma, Lantheus' Tauklarify for Alzheimer's diagnosis, and Regeneron's Pasatru for FOP. Each drug showed positive clinical trial results.

Replimune Group (REPL) stock surged 140% in pre-market trading after a favorable FDA advisory committee review of its melanoma therapy RP1. Cantor Fitzgerald upgraded REPL to 'Overweight' from 'Neutral', citing an 'overwhelmingly positive' panel outcome. The FDA is expected to make a final decision by Aug. 2, 2026. REPL's stock has fallen 39% year-to-date.