On 29 May 2026, Replimune announced that, following collaborative communications with the FDA, the company and the FDA have aligned on a path for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. Replimune says it will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent matter upon receipt and will prioritise its review in recognition of the significant unmet need for patients in the advanced melanoma community.
This announcement has caused some recovery in Replimune’s share price following the negative impact of the FDA’s April 2026 rejection of the first resubmission of the BLA, which in turn followed the rejection of the original November 2024 application.
Other reports record that Replimune met with the White House and that the FDA has been “pushed” to reexamine the RP1 BLA.