20 October 2025 - Replimune today announced that the US FDA has accepted the resubmission of the biologics license application for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen. 

The PDUFA date set by the FDA is 10 April 2026 based on a Class II resubmission timeline.

Read Replimune press release