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Investor Lawsuit Targets Replimune (REPL) After FDA Deems RP1 Trial Inadequate - Hagens Berman
Prnewswire· 2025-09-04 13:30
Core Viewpoint - A securities class action lawsuit has been filed against Replimune Group, Inc. alleging that the company misled investors regarding the success of its cancer drug RP1, resulting in a 77% stock price crash 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 [1][2]. - The FDA issued a "Complete Response Letter" on July 22, 2025, rejecting the Biologics License Application for RP1, which led to a significant sell-off and a 77% decline in stock price [2][4]. Group 2: Allegations of Misleading Information - The lawsuit claims that Replimune presented an overly optimistic view of the drug's prospects, failing to disclose regulatory concerns that contributed to the stock's collapse [3][4]. - The FDA's rejection letter indicated that the IGNYTE trial was not "well-designed" and lacked substantial evidence of effectiveness due to issues such as patient heterogeneity and flawed design [6][7]. Group 3: Investigation and Implications - Hagens Berman is investigating whether Replimune misled investors about the IGNYTE trial, which was central to the drug's application [5][6]. - The investigation focuses on whether management was aware of the trial's fundamental weaknesses and did not disclose them to investors [6][7].
September 22, 2025 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against REPL
Prnewswire· 2025-09-04 12:45
NEW YORK, Sept. 4, 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:https://securitiesclasslaw.com/securities/replimune-group-inc-loss-submission-form-3/?id=164992&from=4CLASS PERIOD: November ...
Replimune (REPL) Faces Investor Lawsuit After FDA Blocks Cancer Drug Approval - Hagens Berman
Prnewswire· 2025-09-03 20:18
SAN FRANCISCO, Sept. 3, 2025 /PRNewswire/ -- Replimune Group Inc. (NASDAQ: REPL) is under fire from investors following a dramatic regulatory setback that sent its stock into freefall. A newly filed securities class action accuses the biotech firm and its leadership of concealing critical risks tied to its flagship cancer therapy, RP1, and overstating the strength of clinical trial data used to support its FDA application.The lawsuit, filed on behalf of investors who acquired Replimune stock between Novembe ...
Replimune(REPL) - 2025 FY - Earnings Call Transcript
2025-09-03 16:30
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.
Class Action Reminder for REPL Investors: Kessler Topaz Meltzer & Check, LLP Reminds Replimune Group, Inc. (REPL) Investors of Securities Fraud Class Action Lawsuit
Prnewswire· 2025-09-02 14:01
RADNOR, Pa., Sept. 2, 2025 /PRNewswire/ -- The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that a securities class action lawsuit has been filed against Replimune Group, Inc. ("Replimune") (NASDAQ: REPL) on behalf of those who purchased or otherwise acquired Replimune securities between November 22, 2024, and July 21, 2025, inclusive (the "Class Period"). The lead plaintiff deadline is September 22, 2025.CONTACT KESSLER TOPAZ MELTZER & CHECK, LLP:If you suffered Replimune ...
REPLIMUNE GROUP, INC. (NASDAQ: REPL) SHAREHOLDER ALERT Bernstein Liebhard LLP Reminds Replimune Group, Inc. Investors of Upcoming Deadline
GlobeNewswire News Room· 2025-09-02 13:38
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 ...
Levi & Korsinsky Notifies Replimune Group, Inc. Investors of a Class Action Lawsuit and Upcoming Deadline - REPL
Prnewswire· 2025-09-02 12:45
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/ ...
Replimune Announces Type A Meeting Scheduled with FDA
Globenewswire· 2025-09-02 12:00
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].
REPL Class Action Reminder: Investors with Large Losses Should Contact Robbins LLP for Information About the Pending Lead Plaintiff Deadline in the Replimune Group, Inc. Class Action Lawsuit
Prnewswire· 2025-08-29 00:20
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]
Kirby McInerney LLP Reminds Replimune Group, Inc. Investors of Class Action Filing and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-08-27 20:19
NEW YORK, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Kirby McInerney LLP reminds investors who purchased Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) securities to contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests in the securities fraud class action lawsuit at no cost. If you suffered a loss on your Replimune investments, you have until September 22, 2025 to request lead plaintiff appoin ...