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Shareholders that lost money on Replimune Group, Inc. (REPL) Urged to Join Class Action – Contact The Gross Law Firm to Learn More
Globenewswire· 2025-09-18 20:42
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].
Replimune (REPL) Shares Tank 45% After Company Says No Pathway Identified For Lead Drug RP1, Securities Class Action Pending - Hagens Berman
Prnewswire· 2025-09-18 20:40
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]
Replimune Stock Crashes 45% After FDA Meeting On Melanoma Therapy Setback
RTTNews· 2025-09-18 17:35
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]
BREAKING: Replimune Shares Drop Over 40%; Investors Should Contact Block & Leviton By September 22nd To Join Securities Fraud Lawsuit
Globenewswire· 2025-09-18 15:49
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].
Replimune Provides Update Following Type A Meeting with FDA
Globenewswire· 2025-09-18 13:15
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]
Replimune Group, Inc. Securities Fraud Class Action Lawsuit Pending: Contact The Gross Law Firm Before September 22, 2025 to Discuss Your Rights - REPL
Prnewswire· 2025-09-18 12:45
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].
Replimune Group, Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights - REPL
Prnewswire· 2025-09-18 09:48
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]
REPL 6-DAY DEADLINE ALERT: Investor Lawsuit Targets Replimune (REPL) After FDA Deems RP1 Trial Inadequate - Hagens Berman
Prnewswire· 2025-09-16 22:11
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].
Levi & Korsinsky Notifies Replimune Group, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline – REPL
Globenewswire· 2025-09-16 21:16
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].
REPL DEADLINE: ROSEN, NATIONAL INVESTOR COUNSEL, Encourages Replimune Group, Inc. Investors to Secure Counsel Before Important September 22 Deadline in Securities Class Action First Filed by the Firm – REPL
Globenewswire· 2025-09-16 01:24
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].