Replimune shares surge after FDA accepts Melanoma drug resubmission
Replimune Group Inc (NASDAQ: REPL) saw its stock jump 60% after the U.S. Food and Drug Administration (FDA) accepted the company’s resubmission of a Biologics License Application (BLA) for its experimental melanoma treatment, RP1.
The BLA seeks approval for RP1 in combination with nivolumab to treat patients with advanced melanoma who have progressed on anti-PD-1 therapies. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of April 10, 2026, following a Class II resubmission timeline, News.Az reports, citing Bloomberg.
This resubmission follows a complete response letter Replimune received in July 2025, after which the company worked to address the FDA’s feedback by providing additional data and analyses.
“We are pleased the agency has accepted the resubmission of our BLA for RP1,” said Sushil Patel, Ph.D., CEO of Replimune. “RP1 plus nivolumab offers a strong risk-benefit profile for patients with advanced melanoma who have limited treatment options. We look forward to working closely with the agency to expedite this review for patients’ benefit.”
The FDA noted that the resubmission is considered a complete response to the agency’s previous letter. Replimune, a clinical-stage biotechnology company, focuses on developing novel oncolytic immunotherapies aimed at improving outcomes for cancer patients.
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