Replimune's RP1 BLA resubmission accepted by FDA; adcomm expected late July

Replimune Group announced on June 29, 2026 that the FDA 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.¹ The agency classified the submission as a complete, class 1 response, setting a goal date of August 2, 2026, and telling the company to expect an advisory committee meeting toward the end of July.¹

On the clinical side, Replimune highlighted new three-year survival data from the IGNYTE trial presented at the ASCO 2026 annual meeting. In patients whose melanoma had progressed on prior anti-PD-1 therapy, 47.8% of all treated patients were alive at three years, with a median overall survival of 32.9 months, and responders showed an 83.5% three-year survival rate.¹ The company said the global Phase 3 IGNYTE-3 confirmatory trial, comparing RP1 plus nivolumab against physician's choice in advanced melanoma patients who progressed on prior anti-PD-1 and anti-CTLA-4 therapy, is actively enrolling, with overall survival as the primary endpoint and progression-free survival and overall response rate as key secondary endpoints.¹

For RP2, Replimune reported that Phase 1 final data presented at ASCO 2026 showed a 19% objective response rate both as monotherapy and in combination with nivolumab across advanced solid tumors, supporting advancement into a randomized Phase 2/3 trial in metastatic uveal melanoma.¹ That trial, called REVEAL, is actively enrolling and is testing RP2 combined with nivolumab against ipilimumab combined with nivolumab in approximately 280 patients,¹ with a Phase 2/3 transition expected in the first quarter of calendar 2027.¹

On finances, the company reported cash, cash equivalents and short-term investments of $268.9 million as of March 31, 2026, down from $483.8 million a year earlier.¹ Replimune said this balance is expected to fund operations into the first quarter of calendar 2027, covering scale-up for potential RP1 commercialization in skin cancers along with working capital and general corporate needs, excluding any potential revenue.¹