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 complaint alleges that defendants made false statements regarding the IGNYTE trial's prospects, which were known to be inadequate and poorly controlled by the FDA [2] - Defendants' statements about Replimune's business and operations were materially false and misleading, lacking a reasonable basis during the relevant time [2] Group 2: Next Steps for Investors - 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 has a strong track record, having secured hundreds of millions for shareholders and being recognized as one of the top securities litigation firms in the U.S. for seven consecutive years [4]

Core Viewpoint - Replimune's stock has experienced significant volatility, with a nearly 40% decline followed by a further drop of almost 7% after an analyst downgrade, contrasting with the S&P 500's gain of 0.5% [1][2]. Group 1: Analyst Recommendations - Anupam Rama from J.P. Morgan downgraded Replimune's recommendation from neutral to underweight (sell) and withdrew his $6 price target without setting a new one [2]. - Raghuram Selvaraju from H.C. Wainwright reiterated a neutral recommendation on Replimune, but did not specify a price target [5]. Group 2: FDA Developments - The downgrade was influenced by recent discussions between Replimune and FDA officials regarding the investigational melanoma treatment RP1, which did not yield a conclusive outcome [3][4]. - Despite RP1's strong performance in clinical testing, its future approval prospects appear uncertain, with accelerated FDA approval now unlikely [4].

Group 1 - Replimune Group, Inc. experienced a significant decline of 39.40%, closing at $3.46, following regulatory challenges for its melanoma treatment candidate [1][3] - The company met with the US FDA to discuss the complete response letter regarding its biologics license application for RP1, in combination with nivolumab, for advanced melanoma treatment [2] - The FDA's response left Replimune uncertain about the potential for accelerated approval of the drug [3] Group 2 - Replimune's CEO emphasized the unmet need in advanced melanoma and the favorable risk-benefit profile of RP1 observed in the IGNYTE trial, expressing commitment to work with the FDA for a path forward [4]

Core Viewpoint - Replimune's stock experienced a nearly 40% loss following a meeting with FDA officials regarding its cancer drug RP1, leaving the drug's future uncertain [1][4]. Group 1: Meeting Details - The meeting with the U.S. Food and Drug Administration (FDA) focused on Replimune's RP1, which is being tested as a combination therapy with Bristol Myers Squibb's Opdivo for advanced melanoma [2]. - The FDA had previously sent a complete response letter to Replimune in June, indicating that RP1 would not be approved, which surprised the company and its shareholders due to the drug's promising clinical results [3]. Group 2: Investor Reaction - Investors interpreted the neutral statement from Replimune regarding the future of RP1 as a sign that the program might be discontinued, leading to a significant sell-off of the stock [4].

Core Viewpoint - The Gross Law Firm is notifying shareholders of Replimune Group, Inc. about a class action lawsuit related to misleading statements made by the company during a specific period [1][3]. Group 1: Class Action Details - The class period for the lawsuit is from November 22, 2024, to July 21, 2025 [3]. - Allegations include that the defendants overstated the prospects of the IGNYTE trial, which the FDA deemed inadequate and not well-controlled [3]. - The misleading statements about Replimune's business and operations resulted in material misrepresentation [3]. Group 2: Shareholder Actions - Shareholders are encouraged to register for the class action by September 22, 2025, to potentially be appointed as lead plaintiffs [4]. - Registration allows shareholders to receive updates through a portfolio monitoring software regarding the case [4]. - Participation in the case incurs no cost or obligation for shareholders [4]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm focused on protecting investors' rights against deceit and fraud [5]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [5].

Core Viewpoint - Replimune Group, Inc. experienced a significant stock price decline of approximately 45% following the announcement that the FDA has not determined a path forward for its lead drug candidate RP1 under the accelerated approval pathway after a Type A meeting [1] Group 1: FDA Interaction and Stock Impact - On September 16, 2025, Replimune completed a Type A meeting with the FDA regarding its Biologics License Application (BLA) for RP1, but no clear path for accelerated approval was established [1] - The company's stock had previously plummeted by 77% on July 22, 2025, after the FDA issued a Complete Response Letter (CRL) rejecting the BLA for RP1, resulting in billions in market value loss [2][3] Group 2: Legal Actions and Allegations - A securities class action lawsuit has been filed against Replimune, alleging that the company misled investors by overstating the success of RP1, which contributed to the stock's dramatic decline [2][4] - The lawsuit claims that Replimune failed to disclose regulatory concerns regarding the IGNYTE trial, which was deemed not well-designed or controlled by the FDA [3][4] Group 3: Investigation Insights - Hagens Berman is investigating whether Replimune misled investors about the likelihood of success for the IGNYTE trial, citing fundamental flaws in the trial's design and patient population [5][6][7] - The investigation focuses on whether management was aware of the trial's inadequacies and failed to disclose this information to investors [6][7]

Core Viewpoint - Replimune Group, Inc. experienced a significant stock decline of 44.74% following the completion of a Type A meeting with the U.S. FDA regarding its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma [1] Stock Performance - The stock price fell to $3.15, down $2.55 from the previous close of $5.71, with trading occurring between $3.15 and $4.44 [1] - Trading volume increased to 15.9 million shares, surpassing the average of 9.3 million shares [2] - Replimune's stock is currently within a 52-week range of $2.68 to $17.00 [2]

Core Viewpoint - Replimune Group, Inc. is facing a securities fraud lawsuit following significant stock price declines due to regulatory setbacks and alleged misleading statements regarding its clinical trials [1][3]. Group 1: Stock Performance and Regulatory Issues - Replimune's stock plummeted over 70% on July 22 after receiving a Complete Response Letter (CRL) from the FDA, which rejected its application for an advanced melanoma therapy due to insufficient clinical evidence from a Phase 2 study [2]. - The stock experienced another decline of over 40% on September 18 after a Type A meeting with the FDA, leaving the path forward under the accelerated approval pathway uncertain [2]. Group 2: Legal Actions and Investor Eligibility - A complaint has been filed against Replimune, alleging that the company made materially false and misleading statements about its IGNYTE clinical trial and the prospects for regulatory approval of its treatment [3]. - Investors who purchased Replimune common stock between November 22, 2024, and July 21, 2025, and have experienced losses may be eligible to participate in the lawsuit [4]. Group 3: Next Steps for Investors - The deadline for investors to seek appointment as lead plaintiff is September 22, 2025, and a class has not yet been certified [5]. - Investors are encouraged to contact Block & Leviton for more information on how to proceed if they have lost money on their investment [5]. Group 4: Whistleblower Information - Individuals with non-public information about Replimune are encouraged to assist in the investigation or file a report with the SEC under the whistleblower program, potentially receiving rewards of up to 30% of any successful recovery [6]. Group 5: Firm Background - Block & Leviton is recognized as a leading securities class action firm, having recovered billions for defrauded investors and representing many top institutional investors [7].

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].