Replimune Group, Inc. (NASDAQ: REPL) announced that the U.S. Food and Drug Administration has accepted for review the resubmission of the Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

The FDA classified the resubmission as a complete, class 1 response and set a goal date of August 2, 2026. The agency also notified Replimune to expect an advisory committee meeting in late July 2026.

The resubmission seeks accelerated approval based on data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed disease progression on an anti-PD-1 containing regimen.

Sushil Patel, Ph.D., CEO of Replimune, said: "We look forward to a productive scientific and clinical discussion on the risk/benefit profile of RP1 in this difficult to treat setting."

RP1 is based on a strain of herpes simplex virus engineered with a fusogenic protein and GM-CSF, and is designed to target tumor cells while stimulating an immune response.

According to the company's press release, melanoma is the fifth most common cancer in the United States, with approximately 112,000 new cases estimated in 2026 and roughly 8,500 deaths annually. Approximately half of patients with advanced melanoma do not respond to or progress after standard immune checkpoint blockade therapy.