RP1 (vusolimogene oderparepvec)

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Rosen Law Firm Encourages Replimune Group, Inc. Investors to Inquire About Securities Class Action Investigation - REPL
Prnewswire· 2025-07-24 00:33
Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Replimune Group, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Replimune Group, Inc. received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for RP1, indicating that the application cannot be approved in its current form [3]. - The FDA stated that the IGNYTE trial does not provide substantial evidence of effectiveness, which contributed to a significant drop in Replimune's stock price [3]. - Following the announcement of the CRL, Replimune's common stock fell by $9.52 per share, representing a decline of over 77%, closing at $2.80 on July 22, 2025 [3]. Group 2: Legal Action and Investor Rights - Investors who purchased Replimune securities may be entitled to compensation through a class action lawsuit, with no out-of-pocket fees due to a contingency fee arrangement [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. - The firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4].
REPLIMUNE ALERT: Bragar Eagel & Squire, P.C. is Investigating Replimune Group, Inc. on Behalf of Replimune Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-07-23 22:52
Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Replimune Group, Inc. following a significant stock price drop after the FDA issued a Complete Response Letter regarding its Biologics License Application for RP1 [1][3]. Company Summary - Replimune Group, Inc. (NASDAQ: REPL) faced a major setback when the FDA issued a Complete Response Letter on July 22, 2025, indicating that the application for RP1 in combination with nivolumab for advanced melanoma could not be approved in its current form [3]. - The FDA's letter highlighted that the IGNYTE trial was not considered adequate and well-controlled, lacking substantial evidence of effectiveness due to the heterogeneity of the patient population [3]. - Following the announcement, Replimune's stock price plummeted by $9.52, or 77.24%, closing at $2.81 per share [3]. Legal Investigation - Bragar Eagel & Squire, P.C. is encouraging investors who suffered losses from Replimune's stock decline to contact them to discuss potential legal rights and claims [1][4]. - The law firm is specifically looking into whether Replimune violated federal securities laws or engaged in unlawful business practices [1].
INVESTOR ALERT: Investigation of Replimune Group, Inc. (REPL) Announced by Holzer & Holzer, LLC
GlobeNewswire News Room· 2025-07-22 17:17
ATLANTA, July 22, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) complied with federal securities laws. On July 22, 2025, Replimune announced it received a Complete Response Letter (“CRL”) from the FDA regarding the Biologics License Application (“BLA”) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. In the CRL, the FDA indicated “that the IGNYTE trial is not ...