Core Viewpoint - Replimune Group, Inc. has completed a Type A meeting with the FDA regarding the complete response letter for its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment [1][2] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, founded in 2015 and headquartered in Woburn, MA [4] - The company's lead product candidate, RP1 (vusolimogene oderparepvec), is engineered from a proprietary strain of herpes simplex virus designed to enhance tumor killing and activate systemic anti-tumor immune responses [3][4] FDA Interaction - The company is currently evaluating FDA feedback from the recent meeting to determine the next steps, with no clear path forward under the accelerated approval pathway established yet [2] - The CEO emphasized the unmet need in advanced melanoma and the favorable risk-benefit profile of RP1 observed in the IGNYTE trial, indicating a commitment to work with the FDA for a timely resolution [3]

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, which the FDA deemed inadequate [1]. Group 1: Allegations and Class Period - The class period for the lawsuit is from November 22, 2024, to July 21, 2025 [1]. - Allegations include that defendants overstated the IGNYTE trial's prospects and failed to disclose material issues, leading to misleading statements about Replimune's business and operations [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 portfolio monitoring software throughout the case lifecycle [2]. Group 3: Firm's Mission - The Gross Law Firm aims to protect investors' rights against deceit and fraud, ensuring companies adhere to responsible business practices [3].

Group 1 - The DJS Law Group has announced a class action lawsuit against Replimune Group, Inc. for violations of the Securities Exchange Act of 1934, specifically §§10(b) and 20(a) and Rule 10b-5 [1][2] - The class period for the lawsuit is from November 22, 2024, to July 21, 2025, with a deadline for participation set for September 22, 2025 [2] - The complaint alleges that Replimune made false and misleading statements regarding the IGNYTE trial for RP1, indicating that the company was aware of serious issues that could lead to FDA concerns about trial controls [2] Group 2 - Shareholders who purchased shares during the specified class period are encouraged to contact the DJS Law Group for potential lead plaintiff appointments, although this is not a requirement for recovery [2][3] - The DJS Law Group specializes in securities class actions and corporate governance litigation, focusing on enhancing investor returns through advocacy [4]

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].

Core Viewpoint - A class action securities lawsuit has been filed against Replimune Group, Inc. for alleged securities fraud affecting investors between November 22, 2024, and July 21, 2025 [1][2]. Group 1: Lawsuit Details - The lawsuit claims that defendants made false statements regarding the IGNYTE trial's prospects, which were known to be inadequate by the defendants, leading to misleading statements about Replimune's business and operations [2]. - The complaint highlights that the FDA deemed the IGNYTE trial inadequate and not well-controlled, which was not disclosed to investors [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 in any recovery 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, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4]. - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [4].

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 who purchased Replimune securities during this period 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 in the litigation [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 and not well-controlled [5]. - The misleading statements resulted in investors suffering damages 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 the largest settlement against a Chinese company at the time and being ranked No. 1 for securities class action settlements in 2017 [4]. - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].

Accessibility StatementSkip Navigation NEW YORK, Sept. 15, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Replimune Group, Inc. (NASDAQ: REPL). Shareholders who purchased shares of REPL during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: ALLEGATIONS: The complaint alleges that during the class period, Defendants issue ...

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 securities class action is from November 22, 2024, to July 21, 2025 [1]. - Investors who purchased Replimune securities during this period 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 in the litigation [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 and not well-controlled [5]. - The misleading statements resulted in investors suffering damages 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 the largest settlement against a Chinese company at the time and being ranked No. 1 for securities class action settlements in 2017 [4]. - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [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 lawsuit claims that defendants made false statements regarding the IGNYTE trial, overstating its prospects despite known material issues, leading to the FDA deeming the trial inadequate [3]. - Defendants' statements about Replimune's business and operations were allegedly materially false and misleading, lacking a reasonable basis during the relevant time [3]. Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until September 22, 2025, to request appointment as lead plaintiff, although participation does not require this role [4]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [4]. Group 3: Legal Firm Background - Levi & Korsinsky, LLP 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. [5].

Core Viewpoint - A class action securities lawsuit has been filed against Replimune Group, Inc. for alleged securities fraud affecting investors between November 22, 2024, and July 21, 2025 [1][2] Group 1: Lawsuit Details - The lawsuit claims that defendants made false statements regarding the IGNYTE trial's prospects, which were known to be materially inadequate by the defendants [2] - The FDA deemed the IGNYTE trial inadequate and not well-controlled, leading to misleading statements about Replimune's business and operations [2] Group 2: Investor Information - Investors who suffered losses during the specified timeframe have until September 22, 2025, to request appointment as lead plaintiff, although participation does not require this role [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]