Core Viewpoint - Replimune Group Inc. faces significant backlash from investors following a regulatory setback that has led to a dramatic decline in its stock price, primarily due to allegations of misrepresentation regarding its cancer therapy RP1 and its clinical trial data [1][4]. Regulatory Setback - On July 22, 2025, Replimune announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application for RP1, halting the drug's approval process due to concerns about the adequacy of the clinical data [3][6]. - The stock price plummeted by 77% in a single trading session, resulting in billions in lost market capitalization [4]. Legal Allegations - A class action lawsuit has been filed on behalf of investors who purchased Replimune stock between November 22, 2024, and July 21, 2025, claiming that the company misrepresented the likelihood of regulatory success and failed to disclose material deficiencies in its trial design [2][3]. - The lawsuit highlights that Replimune emphasized RP1's "durable response" data while allegedly concealing critical information regarding the trial's design flaws [5]. FDA Concerns - The FDA's rejection was based on two main issues: the trial's design was not sufficiently rigorous to meet FDA standards, and the patient population was deemed too heterogeneous, complicating the assessment of RP1's efficacy [7][8]. - The agency also raised questions about the ability to isolate the effects of RP1 from other drugs used in combination during the trial [8]. Investor Investigation - Hagens Berman Sobol Shapiro LLP is investigating whether Replimune misled investors about regulatory risks and trial limitations, emphasizing the importance of transparency in clinical trial data [7].

Financial Data and Key Metrics Changes - The meeting reported that at least 70,621,628 shares of common stock were represented, out of a total of 77,807,174 shares outstanding, indicating a quorum for business transactions [6][7]. Business Line Data and Key Metrics Changes - No specific data or metrics related to individual business lines were provided in the meeting. Market Data and Key Metrics Changes - No specific market data or metrics were discussed during the meeting. Company Strategy and Development Direction and Industry Competition - The company proposed the election of several directors and the ratification of PricewaterhouseCoopers LLP as the independent registered public accounting firm for the fiscal year ending 03/31/2026, indicating a focus on governance and compliance [11]. Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during the meeting. Other Important Information - The proposal to approve an amendment to the Replimune Group, Inc. 2018 Omnibus Incentive Plan was not passed by the stockholders, which may indicate challenges in aligning executive compensation with shareholder interests [13]. Summary of Q&A Session - No questions or answers were recorded during the meeting.

Core Viewpoint - A securities class action lawsuit has been filed against Replimune Group, Inc. for allegedly making materially false and misleading statements regarding its business and product prospects during the specified class period from November 22, 2024, to July 21, 2025 [1][2]. Group 1: Allegations Against Replimune - The complaint claims that Replimune overstated the trial prospects for its lead product candidate [2]. - It is alleged that the statements made by the defendants about the company's business, operations, and prospects were materially false and misleading, lacking a reasonable basis throughout the class period [2]. Group 2: Lead Plaintiff Process - Investors in Replimune have until September 22, 2025, to seek appointment as a lead plaintiff representative of the class [3]. - The lead plaintiff will act on behalf of all class members and is typically the investor or small group of investors with the largest financial interest [3]. Group 3: Firm Information - Kessler Topaz Meltzer & Check, LLP is known for prosecuting class actions and has recovered billions for victims of fraud and corporate misconduct [4]. - The firm encourages Replimune investors who have suffered significant losses to contact them for more information [4].

NEW YORK, Sept. 02, 2025 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) investors of an upcoming deadline involving a securities fraud class action lawsuit commenced against the Company. Should You Join This Class Action Lawsuit? Do you, or did you, own shares of Replimune Group, Inc. (NASDAQ: REPL)?Did you purchase your shares between November 22, 2024, and July 21, 2025, inclusive?Did ...

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].