Group 1 - The Rosen Law Firm is reminding purchasers of Replimune Group, Inc. securities about a lead plaintiff deadline for a securities class action [1] - The class period for the securities in question 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 expenses [1]

Group 1 - The article discusses the services offered by Biotech Analysis Central, which provides in-depth analysis of pharmaceutical companies and investment opportunities in the biotech sector [1][2] - A two-week free trial is currently available for new subscribers, with a monthly subscription priced at $49, and an annual plan offering a 33.50% discount at $399 [1] - The author has previously covered Replimune, indicating a focus on specific biotech companies and their market potential [2] Group 2 - The article emphasizes the importance of informed decision-making for healthcare investors, supported by a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks [2] - The author expresses no current financial interest in the companies mentioned, ensuring an unbiased perspective in the analysis [3] - Seeking Alpha clarifies that past performance does not guarantee future results, highlighting the need for careful consideration in investment decisions [4]

NEW YORK, Sept. 19, 2025 (GLOBE NEWSWIRE) -- 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/p ...

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].