REPL 6-DAY DEADLINE ALERT: Investor Lawsuit Targets Replimune (REPL) After FDA Deems RP1 Trial Inadequate - Hagens Berman

Core Viewpoint - A securities class action lawsuit has been filed against Replimune Group, Inc. for allegedly misleading investors about the success of its cancer drug RP1, leading to a 77% stock price drop after the FDA rejected its application [1][2]. Group 1: Lawsuit Details - The lawsuit, Jboor v. Replimune Group, Inc., represents investors who purchased Replimune securities between November 22, 2024, and July 21, 2025 [2]. - The FDA issued a "Complete Response Letter" on July 22, 2025, rejecting the Biologics License Application for RP1, which caused a significant sell-off and a 77% decline in stock price [2][3]. - The complaint alleges that Replimune provided a misleadingly optimistic view of RP1's prospects, with the FDA's CRL indicating that the IGNYTE trial was not adequately designed or controlled [3][4]. Group 2: Regulatory Concerns - The lawsuit claims that Replimune failed to disclose regulatory concerns that directly contributed to the stock's collapse, resulting in substantial losses for investors [4]. - The FDA's rejection letter highlighted fundamental flaws in the IGNYTE trial, including issues with patient heterogeneity and trial design, which compromised the integrity of the data [6][7]. - The company allegedly overstated the likelihood of success for the IGNYTE trial, which the FDA deemed inadequate for approval [7]. Group 3: Investigation and Whistleblower Information - Hagens Berman is actively investigating whether Replimune misled its investors regarding the trial's design and results [5][6]. - Whistleblowers with non-public information about Replimune are encouraged to assist in the investigation, with potential rewards under the SEC Whistleblower program [8].