Replimune's TUDRIQEV wins FDA accelerated approval, launch set within 60 days

Replimune Group announced on August 6, 2026 that the FDA approved TUDRIQEV (vusolimogene oderparepvec-wtpg), previously known as RP1, in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who progressed on a PD-1 antibody-based regimen.¹ The approval is accelerated, based on objective response rate and duration of response, with continued approval contingent on verifying clinical benefit in a confirmatory trial or trials.¹ The company has begun launch preparations in the U.S. and expects product in the market within 60 days.¹

That confirmatory trial, IGNYTE-3, is a global Phase 3 study comparing RP1 plus nivolumab to physician's choice in advanced melanoma patients who progressed on anti-PD-1 and anti-CTLA-4 therapy or are ineligible for anti-CTLA-4 treatment, and it is actively enrolling.¹ Its primary endpoint of overall survival is expected to read out in 2030, with progression free survival and overall response rate as key secondary endpoints.¹

On the RP2 program, the REVEAL study, a registration-directed Phase 2/3 trial of RP2 in metastatic uveal melanoma, is enrolling roughly 280 patients comparing RP2 plus nivolumab against ipilimumab plus nivolumab, with co-primary endpoints of overall survival and progression free survival.¹ The Phase 2/3 transition is expected in the first quarter of 2027.¹

Replimune also named Michelle DiNapoli as Chief Commercial Officer, effective August 18, 2026,¹ after prior roles at Deciphera Pharmaceuticals and Genentech.

On finances, cash, cash equivalents and short-term investments were $195.3 million as of June 30, 2026, down from $268.9 million at the end of the prior fiscal year.¹ Combined with $141.0 million in net proceeds from an August 2026 stock issuance, the company said it expects to fund operations for more than twelve months, including scale-up of TUDRIQEV's commercialization.¹