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Replimune Group (REPL, Financials) shares surged 17% to $11.85 as of 10:18 a.m. ET Tuesday after the U.S. Food and Drug Administration granted Priority Review for its Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma.
The Prescription Drug User Fee Act action date the FDA designated is July 22, 2025.
The agency said it has not found any major review problems and that it does not intend to convene an advisory committee meeting for this application. Primary results from the IGNYTE study, which assessed RP1 coupled with nivolumab in patients whose melanoma advanced after anti-PD-1 treatment, support the BLA.
Undergoing in more than 100 scheduled worldwide locations, IGNYTE-3 is a confirmatory Phase 3 study further evaluating RP1's efficacy in patients who have failed anti-PD-1 and anti-CTLA-4 therapy or are ineligible for the latter.
The CEO of Replimune, Sushil Patel, Ph.D., underlined the critical need of medicines aiming at advanced melanoma and the few choices accessible to patients who have previously undergone anti-PD-1 therapy. For the business, Patel said the FDA's approval of the BLA marks a major turning point.
Therapies that, should they be authorized, significantly enhance the treatment of major diseases are given Priority Review by the FDA. Safety and clinical activity shown in the anti-PD-1 failing melanoma group of the IGNYTE study prompted RP1 to recently achieve Breakthrough Therapy designation.
Fifth most frequent cancer in the United States, melanoma accounts for around 100,000 new cases yearly and causes roughly 8,000 deaths. For just over half of patients, standard medicines including immune checkpoint inhibitors are successful; for those who fail first treatments, there are few alternatives.
Based on a modified herpes simplex virus intended to boost tumor elimination and set off a systemic immune response, RP1, Replimune's flagship candidate, Founded in 2015 and with its headquarters in Woburn, Massachusetts, the firm employs its own RPx platform to concentrate on creating new oncolytic immunotherapies.
This article first appeared on GuruFocus.