Replimune to Resubmit Twice-Rejected Melanoma Drug After FDA Leadership Change

Replimune announced Friday it plans to resubmit its melanoma treatment to the U.S. Food and Drug Administration for review, following a leadership shakeup at the agency. The company’s shares surged as much as 70% in premarket trading on the news.

Regulatory Dispute and Leadership Change

The FDA had twice rejected Replimune’s melanoma therapy under the previous administration of former Commissioner Marty Makary, who stepped down earlier this month. Replimune had accused the FDA of wrongfully blocking what some physicians view as a promising new approach to treating skin cancer. The FDA countered that Replimune had ignored the agency’s guidance for conducting its clinical trials. The bitter disagreement became a flashpoint for criticism within the drug industry, with some companies alleging mixed messaging from the FDA under Makary’s leadership. Certain drugmakers argued that the agency’s reversals on guidance around clinical trials and approvals for experimental drugs jeopardized future treatment development.

Path to Resubmission

Replimune stated that it and the FDA are now aligned on a forward path, and the company will resubmit its application in the coming days. The FDA has indicated it will treat the submission as an urgent matter and prioritize its review. “This constructive dialogue represents an important step forward for the thousands of patients living with advanced melanoma who have progressed on prior anti-PD-1 based therapy and have limited treatment options available to them,” Replimune said in a statement.

Market Context

Replimune had a market value of $386 million as of Thursday’s close. As of May 29, 2026, the U.S. dollar traded at 71.02 Russian rubles (change: -0.35), the euro at 82.64 rubles (change: -1.05), bitcoin at $73,679 (24-hour change: +0.8%), and crude oil was estimated at approximately $72 per barrel.