NEW YORK, Sept. 2, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Replimune Group, Inc. ("Replimune Group, Inc." or the "Company") (NASDAQ: REPL) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Replimune Group, Inc. investors who were adversely affected by alleged securities fraud between November 22, 2024 and July 21, 2025. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/pslra-1/ ...

Core Viewpoint - Replimune Group, Inc. is engaging with the FDA to discuss the complete response letter for its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment, emphasizing the urgent need for access to this therapy in the melanoma community [1][3]. Company Overview - Replimune Group, Inc. is a clinical-stage biotechnology company founded in 2015, focused on developing novel oncolytic immunotherapies to transform cancer treatment [5]. - The company's lead product candidate, RP1, is based on a proprietary strain of herpes simplex virus engineered to enhance tumor killing potency and activate systemic anti-tumor immune responses [4][5]. FDA Interaction - A Type A meeting with the FDA has been scheduled to address the complete response letter concerning the BLA for RP1, with the company submitting a briefing book that responds to the FDA's concerns [1][2]. - The briefing book includes prior agreements on patient population, PD-1 resistance criteria, and additional data analysis from the BLA [2]. Community Support - The melanoma community, including physicians and patient advocacy groups, has highlighted the urgent need for RP1 due to limited effective treatment options available [3].

Group 1 - A class action has been filed on behalf of investors who purchased Replimune Group, Inc. (NASDAQ: REPL) securities between November 22, 2024, and July 21, 2025 [1] - Robbins LLP is investigating allegations that Replimune Group, Inc. misled investors regarding the viability of its IGNYTE trial, claiming that the company overstated the trial's prospects and failed to disclose material issues [2] - On July 22, 2025, Replimune announced it received a complete response letter (CRL) from the FDA, indicating that the IGNYTE trial was not considered adequate, leading to a significant stock price drop of $9.52 per share, or 77.24%, closing at $2.80 per share [3] Group 2 - Shareholders interested in participating as lead plaintiffs must file their papers with the court by September 22, 2025, and can remain absent class members if they choose not to participate [4] - Robbins LLP operates on a contingency fee basis, meaning shareholders pay no fees or expenses [5] - The firm has been dedicated to helping shareholders recover losses and improve corporate governance since 2002 [5]

Core Viewpoint - Replimune Group, Inc. is facing a securities fraud class action lawsuit following a significant decline in its stock price after the FDA issued a Complete Response Letter regarding its lead product RP1, indicating inadequacies in the clinical trial [3][4]. Group 1: Company Overview - Replimune Group, Inc. is a biotechnology company focused on developing immunotherapy treatments, specifically for advanced melanoma [3]. - The company's lead product, RP1, was under review by the FDA in combination with nivolumab [3]. Group 2: Recent Developments - On July 22, 2025, Replimune announced it received a Complete Response Letter from the FDA, which stated that the IGNYTE trial was not considered adequate for demonstrating effectiveness [3]. - Following this announcement, Replimune's stock price fell by $9.52, or approximately 77.24%, closing at $2.81 per share [3]. Group 3: Legal Action - A class action lawsuit has been filed on behalf of investors who purchased Replimune securities between November 22, 2024, and July 21, 2025 [4]. - The lawsuit alleges that Replimune made false or misleading statements regarding the IGNYTE trial's prospects, leading to the FDA's negative assessment [4].

Core Viewpoint - A class action securities lawsuit has been filed against Replimune Group, Inc. due to alleged securities fraud affecting investors between November 22, 2024, and July 21, 2025 [1][2]. Group 1: Lawsuit Details - The complaint alleges that defendants made false statements regarding the IGNYTE trial's prospects, which were known to be inadequate and not well-controlled by the FDA [2]. - Defendants' statements about Replimune's business, operations, and prospects were claimed to be materially false and misleading [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until September 22, 2025, to request appointment as lead plaintiff [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the U.S. [4].

Core Viewpoint - Replimune Group, Inc. faces a securities class action lawsuit following the FDA's rejection of its cancer drug RP1, which led to a significant drop in stock value and allegations of misleading investors regarding trial data and regulatory risks [1][2][3]. 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, with a lead plaintiff deadline set for September 22, 2025 [2]. - The FDA issued a Complete Response Letter (CRL) on July 22, 2025, halting the approval process for RP1, which was intended for advanced melanoma treatment [2][5]. Group 2: Market Reaction - Following the FDA's announcement, Replimune's stock plummeted by 77% in a single day, resulting in billions in lost market value [3]. Group 3: Allegations of Misleading Information - The lawsuit claims Replimune provided a false sense of security by emphasizing prior FDA designations and trial data while failing to disclose critical issues with the IGNYTE trial's design [4][7]. - The FDA's CRL indicated that the IGNYTE trial was not adequately designed to provide substantial evidence of effectiveness, which was not disclosed to investors [4][5]. Group 4: FDA's Rejection Reasons - The FDA's rejection was based on undisclosed methodological issues in the IGNYTE trial, including patient heterogeneity and flaws in the planned confirmatory trial [8][5]. - The agency found the patient population too varied to draw reliable conclusions about the drug's effectiveness and questioned the evaluation of individual contributions in combination therapy [8]. Group 5: Investigation by Hagens Berman - Hagens Berman is investigating whether Replimune misled investors about the FDA's concerns, emphasizing the importance of transparency when a company's valuation relies on a single trial [9].

Core Viewpoint - A class action lawsuit has been filed against Replimune Group, Inc. concerning allegations of securities fraud and unlawful business practices related to the company's recent FDA response regarding its drug application [1][2]. Group 1: Lawsuit Details - The class action lawsuit is focused on whether Replimune and certain officers or directors engaged in securities fraud or other unlawful business practices [2]. - Investors have until September 22, 2025, to request to be appointed as Lead Plaintiff if they purchased Replimune securities during the Class Period [2]. Group 2: FDA Response and Stock Impact - On July 22, 2025, Replimune received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma [4]. - The CRL indicated that the FDA could not approve the application in its current form, citing inadequacies in the IGNYTE trial and issues with the patient population's heterogeneity [4]. - Following the announcement, Replimune's stock price fell by $9.52 per share, or 77.24%, closing at $2.81 per share on the same day [4].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Replimune Group, Inc. regarding a class action lawsuit due to alleged misleading statements related to the IGNYTE trial [1][2]. Group 1: Allegations and Class Period - The class period for the allegations is from November 22, 2024, to July 21, 2025 [1]. - The complaint claims that defendants overstated the IGNYTE trial's prospects, leading to the FDA deeming the trial inadequate [1]. - It is alleged that the defendants' statements about Replimune's business and operations were materially false and misleading [1]. Group 2: Next Steps for Shareholders - Shareholders are encouraged to register for the class action by September 22, 2025, to potentially become lead plaintiffs [2]. - Registered shareholders will receive updates through a portfolio monitoring software regarding the case's status [2]. - Participation in the case incurs no cost or obligation for shareholders [2]. Group 3: About the Gross Law Firm - The Gross Law Firm is a nationally recognized class action law firm focused on protecting investors' rights against deceit and fraud [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [3].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Replimune Group, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline for a securities class action lawsuit [1][2]. Group 1: Class Action Details - The Class Period for the Replimune securities class action is from November 22, 2024, to July 21, 2025 [1]. - Investors may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A lead plaintiff must file a motion with the Court by September 22, 2025, to represent other class members [3]. Group 2: Case Background - The lawsuit alleges that defendants made materially false and misleading statements regarding the IGNYTE trial, which the FDA deemed inadequate [5]. - The misleading statements resulted in damages to investors when the true details about Replimune's business and operations were revealed [5]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements, including the largest against a Chinese company at the time [4]. - The firm has been consistently ranked among the top firms for securities class action settlements since 2013, recovering hundreds of millions for investors [4].

Core Viewpoint - A class action securities lawsuit has been filed against Replimune Group, Inc. due to alleged securities fraud affecting investors between November 22, 2024, and July 21, 2025 [1][2]. Group 1: Lawsuit Details - The complaint alleges that defendants made false statements regarding the IGNYTE trial's prospects, which were known to be materially inadequate by the defendants [2]. - The lawsuit claims that the defendants' statements about Replimune's business and operations were materially false and misleading, lacking a reasonable basis [2]. Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until September 22, 2025, to request to be appointed as lead plaintiff, although participation does not require this [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [4].