FDA approves Replimune's melanoma drug after two rejections

What happened

Replimune Group, Inc., a clinical-stage biotechnology company focused on oncolytic immunotherapies, received FDA approval for its lead drug candidate, vusolimogene oderparepvec (also known as RP1 and brand name Tudriqev), for the treatment of advanced refractory melanoma. The approval was reported by STAT News on August 6, 2026.

The drug had been rejected twice by the FDA prior to this approval, according to STAT News. Replimune's stock rose 5.12% on the day, closing at $14.77, up from $14.05.

Background and approval path

The approval follows a favorable vote by an FDA advisory committee. On July 30, 2026, the committee voted 10-3 that efficacy results from the IGNYTE study were evaluable and clinically meaningful for RP1, as reported by CureToday and Reuters.

The advisory committee's vote was seen as raising the chances of FDA approval ahead of an August 2 decision deadline, per Yahoo News.

RP1 is based on a proprietary strain of herpes simplex virus, according to Replimune's investor release. The company's web page describes RP1 as its lead product candidate.

What this means

RP1 is an oncolytic viral therapy: a genetically modified virus designed to infect and kill cancer cells while also stimulating an immune response. This is a type of cancer immunotherapy.

The FDA approval is a major regulatory reversal for Replimune, a company whose fortunes had been uncertain after two prior rejections. The approval could allow Replimune to begin commercial sales of its first drug, potentially generating revenue for the first time.

The approval is conditional on a confirmatory trial, according to STAT News. This means the company must conduct additional studies to verify clinical benefit, a common requirement for accelerated approvals.

Note: The pricing of the drug and other details reported on X were not verified and are excluded from this article.