By Xavier Martinez

Replimune Group said Friday it has reached an agreement with the Food and Drug Administration on a path to resubmit its application for its experimental treatment for advanced melanoma.

It wasn't immediately clear whether Replimune would submit new clinical data or additional analyses of existing trial results to help secure approval.

The company plans to resubmit the application in the coming days, the company said. Replimune shares were up more than 70% in premarket trading.

The move marks a sharp reversal for a drug that became one of the most contentious rejections for the agency under the leadership of former FDA Commissioner Marty Makary and illustrates how quickly priorities are shifting in the agency in the wake of the commissioner's departure earlier this month.

The FDA twice rejected Replimune's application for approval, first in July 2025 and again in April, saying the data from a single-arm trial, in which all patients received the experimental drug with no comparison group, fell short of proving to the agency that the treatment worked. The agency also said the mix of patients enrolled made the results hard to interpret.

About a third of patients with treatment-resistant melanoma saw their tumors shrink after taking Replimune's drug combined with a second cancer drug, Bristol-Myers Squibb's Opdivo.

Replimune had accused the FDA of being inconsistent in prior rejections of its drug with different teams reviewing its drug each time.

While still head of the agency, Makary publicly defended rejecting Replimune's drug. "If your drug works, it's going to get approved," he said in an interview with CNBC.

More than 110,000 people in the U.S. are expected to be diagnosed with melanoma this year, the National Cancer Institute estimates, and more than 8,000 people with advanced disease are expected to die nationwide.

The FDA's reversal comes less than three weeks after Makary's resignation. Kyle Diamantas, a lawyer who was overseeing food regulation at the agency, has since been named acting commissioner.

Write to Xavier Martinez at xavier.martinez@wsj.com

(END) Dow Jones Newswires

May 29, 2026 08:19 ET (12:19 GMT)

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