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REPL STOCK NEWS: Replimune Group, Inc. (NASDAQ:REPL) is Facing a Securities Fraud Investigation – Investors with Losses are Notified to Contact BFA Law
ReplimuneReplimune(US:REPL) GlobeNewswire News Room·2025-07-24 12:07

Core Viewpoint - Replimune Group, Inc. is under investigation for potential violations of federal securities laws following a significant decline in stock price after the FDA's response regarding its lead product candidate RP1 [1][4]. Company Overview - Replimune is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with RP1 as its lead product candidate aimed at melanoma [2]. Clinical Trial Results - On June 6, 2024, Replimune announced positive top-line results from the IGNYTE Phase 1/2 clinical trial for RP1 in combination with nivolumab [2]. - The company repeatedly promoted the results of the IGNYTE trial, but the trial design was criticized for not being adequate to produce reliable results [3]. Regulatory Response - On July 22, 2025, Replimune received a Complete Response Letter from the FDA, indicating that the IGNYTE trial was not considered adequate and well-controlled, leading to a significant stock price drop of over 75% [4]. - The FDA specifically noted that the trial's results could not be adequately interpreted due to the heterogeneity of the patient population [4].