Replimune Group Inc (NASDAQ:REPL) surged 60% in premarket trading after the U.S. Food and Drug Administration (FDA) accepted the company’s resubmission of its Biologics License Application (BLA) for RP1, a treatment for advanced melanoma.
The application seeks approval for RP1 in combination with nivolumab to treat patients with advanced melanoma who have progressed on anti-PD-1–based therapies. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of April 10, 2026, following a Class II resubmission timeline.
This marks a pivotal step forward for Replimune after receiving a complete response letter from the FDA in July 2025. Over the past several months, the company worked to address the agency’s feedback with additional data, information, and analyses included 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 confirmed that this resubmission fully addresses the issues outlined in its previous letter. Replimune, a clinical-stage biotech company, is focused on developing novel oncolytic immunotherapies designed to stimulate immune responses against cancer.
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