Replimune (REPL) Faces Securities Class Action Following Stock's Collapse Amid FDA's Rejection of Melanoma Drug - Hagens Berman

Core Viewpoint - A securities class action lawsuit has been filed against Replimune Group, Inc. following a significant drop in its stock price after the FDA rejected its drug application for RP1, intended for advanced melanoma treatment [1][2]. Group 1: Lawsuit Details - The lawsuit, Jboor v. Replimune Group, Inc., seeks to represent investors who acquired Replimune securities between November 22, 2024, and July 21, 2025 [1][4]. - The lead plaintiff deadline for the lawsuit is set for September 22, 2025 [4]. Group 2: FDA Rejection and Market Reaction - Replimune's stock price plummeted by 77% on July 22, 2025, after the FDA issued a "complete response letter" rejecting the application for RP1, citing inadequacies in the IGNYTE trial [2][7]. - The FDA's letter indicated that the IGNYTE trial was not well-designed or controlled, leading to concerns about the drug's effectiveness [7][8]. Group 3: Allegations Against Replimune - The complaint alleges that Replimune made false and misleading statements regarding the IGNYTE trial's prospects and failed to disclose that the trial was likely deemed inadequate by the FDA [6][9]. - Replimune had previously portrayed an optimistic outlook for RP1, highlighting its Breakthrough Therapy designation and the potential for durable responses in patients [5][6]. Group 4: Investigation and Whistleblower Information - Hagens Berman is investigating whether Replimune misled investors about the IGNYTE trial design and data, urging affected investors to come forward [3][9]. - Whistleblowers with non-public information regarding Replimune are encouraged to assist in the investigation, with potential rewards under the SEC Whistleblower program [10].