RP-1

Replimune's BLA for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma is proceeding on schedule with a PDUFA date of July 22, 2025, following completed manufacturing inspections and late cycle review.

Replimune has initiated two clinical trials for RP2, an oncolytic immunotherapy, targeting metastatic uveal melanoma and hepatocellular carcinoma.

Extended analysis of the RELATIVITY-047 trial shows nivolumab/relatlimab significantly improves overall survival compared to nivolumab alone in advanced melanoma patients.

The FDA has granted priority review to Replimune's BLA for RP1 in combination with nivolumab for advanced melanoma, setting a PDUFA action date of July 22, 2025.

The FDA is evaluating a biologics license application for RP1 plus nivolumab to treat advanced melanoma in adults who have previously received a PD-1 inhibitor.