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Investing.com -- Replimune Group Inc (NASDAQ:REPL) stock soared 60% after the U.S. Food and Drug Administration (FDA) accepted the company’s resubmission of a Biologics License Application (BLA) for its RP1 treatment.
The BLA seeks approval for RP1 in combination with nivolumab to treat advanced melanoma patients who progress on anti-PD-1 containing regimens. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of April 10, 2026, based on a Class II resubmission timeline.
This acceptance represents a significant milestone for Replimune following the complete response letter it received from the FDA in July 2025. The company has been working to address agency feedback over the past few months, including additional information, data, and analyses in its resubmission.
"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 where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy. We look forward to working closely with the agency to expedite this review as much as possible for patients’ benefit."
The FDA indicated that this resubmission is considered a complete response to the complete response letter received earlier. Replimune, a clinical stage biotechnology company, focuses on developing novel oncolytic immunotherapies.
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