Replimune Group Inc. has reached an agreement with the U.S. Food and Drug Administration on a plan to resubmit the marketing application for its investigational therapy for advanced melanoma.
The company announced on Friday that it has finalized the resubmission plan with the FDA, though it remains unclear whether the application will include new clinical data or a further analysis of existing trial results.
Replimune stated it plans to complete the resubmission in the coming days. Following the announcement, the company's stock surged more than 70% in pre-market trading.
The drug candidate had previously been rejected twice by the FDA. The rejections, which occurred under former FDA Commissioner Dr. Marty Makary, were among the most contentious during his tenure. The significant shift in the regulatory stance reflects rapid changes at the agency following Makary's departure earlier this month.
The FDA denied the applications in July 2025 and again in April of this year, citing concerns over the single-arm trial design—where all participants received the investigational drug without a control group—and stating the data was insufficient to demonstrate efficacy. The agency also noted the complexity of the enrolled patient population made the results difficult to interpret.
Clinical data showed that approximately one-third of patients with treatment-resistant melanoma experienced tumor shrinkage when the therapy was used in combination with Bristol Myers Squibb's cancer drug, Opdivo.
Replimune had previously criticized the FDA for inconsistent review standards, attributing this to different review teams handling the application each time.
During his tenure, Dr. Makary publicly supported the decision to reject the drug. In an interview with CNBC, he stated, "If a drug truly works, it will ultimately get approved."
The National Cancer Institute estimates that over 110,000 new cases of melanoma will be diagnosed in the United States this year, with more than 8,000 deaths expected among patients with advanced disease.
This change in the FDA's position comes less than three weeks after Dr. Makary's resignation. Kyle Diamantas, the former head of the agency's food regulation division, has been appointed as acting commissioner.