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Investing.com -- Replimune Group, Inc. (NASDAQ:REPL) stock plunged 77% after the company announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) rejecting its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment.
The FDA stated that the IGNYTE trial supporting the application was not considered "an adequate and well-controlled clinical investigation" and failed to provide substantial evidence of effectiveness. Regulators cited concerns about the heterogeneity of the patient population, making the trial results difficult to interpret properly.
The agency also raised issues with the confirmatory trial study design, including questions about the contribution of components. However, no safety concerns were identified in the CRL.
Replimune expressed surprise at the decision, noting that the issues highlighted in the rejection letter were not previously raised during mid- and late-cycle reviews. The company also stated it had already aligned with the FDA on the design of the confirmatory study.
"We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data," said Sushil Patel, Ph.D., Chief Executive Officer of Replimune.
The clinical-stage biotechnology company plans to request a Type A meeting with the FDA, which it expects will be granted within 30 days. Replimune indicated it will "urgently interact" with regulators to find a path forward for accelerated approval, warning that without such approval, "the development of RP1 for advanced cancer patients with limited options will not be viable."
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