Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Replimune Group, Inc. due to allegations of violations of federal securities laws related to misleading statements about the IGNYTE trial and its FDA approval process [2][4]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi is encouraging investors who suffered losses exceeding $50,000 in Replimune between November 22, 2024, and July 21, 2025, to discuss their legal options [1]. - A federal securities class action has been filed against Replimune, with a deadline of September 22, 2025, for investors to seek the role of lead plaintiff [2]. - The complaint alleges that Replimune and its executives made false and misleading statements regarding the IGNYTE trial, which the FDA deemed inadequate [4]. Group 2: Impact of FDA Response - On July 22, 2025, Replimune received a Complete Response Letter (CRL) from the FDA, indicating that the application for RP1 was not approved in its current form due to inadequacies in the IGNYTE trial [5]. - Following the announcement of the CRL, Replimune's stock price fell over 73% during intraday trading on the same day [5]. Group 3: Firm Background and Contact Information - Faruqi & Faruqi, LLP is a national securities law firm with a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [3]. - The firm is also seeking information from whistleblowers, former employees, and shareholders regarding Replimune's conduct [7].

Core Viewpoint - A securities class action lawsuit has been filed against Replimune Group, Inc. following a significant drop in its stock price after the FDA rejected its drug application for RP1, intended for advanced melanoma treatment [1][2]. Group 1: Lawsuit Details - The lawsuit, Jboor v. Replimune Group, Inc., seeks to represent investors who acquired Replimune securities between November 22, 2024, and July 21, 2025 [1][4]. - The lead plaintiff deadline for the lawsuit is set for September 22, 2025 [4]. Group 2: FDA Rejection and Market Reaction - Replimune's stock price plummeted by 77% on July 22, 2025, after the FDA issued a "complete response letter" rejecting the application for RP1, citing inadequacies in the IGNYTE trial [2][7]. - The FDA's letter indicated that the IGNYTE trial was not well-designed or controlled, leading to concerns about the drug's effectiveness [7][8]. Group 3: Allegations Against Replimune - The complaint alleges that Replimune made false and misleading statements regarding the IGNYTE trial's prospects and failed to disclose that the trial was likely deemed inadequate by the FDA [6][9]. - Replimune had previously portrayed an optimistic outlook for RP1, highlighting its Breakthrough Therapy designation and the potential for durable responses in patients [5][6]. Group 4: Investigation and Whistleblower Information - Hagens Berman is investigating whether Replimune misled investors about the IGNYTE trial design and data, urging affected investors to come forward [3][9]. - Whistleblowers with non-public information regarding Replimune are encouraged to assist in the investigation, with potential rewards under the SEC Whistleblower program [10].

Core Viewpoint - Rosen Law Firm has filed a class action lawsuit on behalf of purchasers of Replimune Group, Inc. securities for the period between November 22, 2024, and July 21, 2025, due to alleged misleading statements regarding the IGNYTE trial [1][5]. Group 1: Lawsuit Details - The lawsuit claims that defendants made materially false and misleading statements about the IGNYTE trial's prospects, which led to the FDA deeming the trial inadequate [5]. - Investors who purchased Replimune securities during the class period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. Group 2: Next Steps for Investors - Interested investors can join the class action by visiting the provided link or contacting the law firm directly for more information [3][6]. - A lead plaintiff must be appointed by September 22, 2025, to represent other class members in the litigation [1][3]. Group 3: Law Firm Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time [4]. - The firm has consistently ranked highly in securities class action settlements and has recovered hundreds of millions of dollars for investors [4].

Attorney advertising. Prior results do not guarantee similar outcomes. CONTACT: Danielle Peyton Pomerantz LLP dpeyton@pomlaw.com 646-581-9980 ext. 7980 On July 22, 2025, Replimune issued a press release "announc[ing] that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma." Per the press release, "[t]he CRL indicates t ...

Core Viewpoint - A lawsuit has been filed against Replimune Group, Inc. and its senior executives for potential violations of federal securities laws, following a significant decline in stock price after the FDA's response regarding the company's lead product candidate RP1 [1][2][5]. Group 1: Company Overview - Replimune is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with its lead product candidate being RP1 for melanoma [3]. - The company announced positive results from its IGNYTE Phase 1/2 clinical trial for RP1 in combination with nivolumab on June 6, 2024, and subsequently submitted a biologics license application (BLA) to the FDA based on these results [3]. Group 2: Legal Issues - The lawsuit claims violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, representing investors who purchased Replimune securities [2]. - The complaint alleges that the IGNYTE Phase 1/2 trial design was inadequate to produce reliable results, despite the company promoting its outcomes [4]. Group 3: Stock Performance - Following the FDA's Complete Response Letter on July 22, 2025, which indicated that the IGNYTE trial was not considered adequate for substantial evidence of effectiveness, Replimune's stock price fell by more than 75% [5].

Plaintiff alleges that on July 22, 2025, Replimune announced that it had received a complete response letter ("CRL") from the FDA for RPI Biologics License Application for the treatment of advanced melanoma and that the CRL "indicates that the FDA is unable to approve the application in its present form because the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. On this news, the price of Replimune stock plummet ...

Core Viewpoint - A class action lawsuit has been filed against Replimune Group, Inc. concerning allegations of securities fraud and unlawful business practices [2][3]. Group 1: Lawsuit Details - The lawsuit involves claims that Replimune and certain officers and/or directors engaged in securities fraud or other unlawful business practices [2]. - Investors who purchased Replimune securities during the Class Period have until September 22, 2025, to request to be appointed as Lead Plaintiff [3]. Group 2: FDA Response and Stock Impact - On July 22, 2025, Replimune announced that the FDA issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma treatment [3]. - The CRL indicated that the FDA could not approve the application in its current form, citing inadequacies in the IGNYTE trial and issues related to the confirmatory trial study design [3]. - Following this announcement, Replimune's stock price fell by $9.52 per share, or 77.24%, closing at $2.81 per share on July 22, 2025 [3].

Core Viewpoint - A lawsuit has been filed against Replimune Group, Inc. and its senior executives for potential violations of federal securities laws, following a significant decline in stock price after the FDA's response regarding the company's lead product candidate RP1 [1][2][5]. Company Overview - Replimune Group, Inc. is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with its lead product candidate being RP1 for melanoma [3]. Clinical Trial and Regulatory Issues - The company announced positive results from the IGNYTE Phase 1/2 clinical trial for RP1 in combination with nivolumab on June 6, 2024, and subsequently submitted a biologics license application (BLA) to the FDA based on these results [3][4]. - However, the FDA issued a Complete Response Letter on July 22, 2025, stating that the IGNYTE trial was not considered adequate for demonstrating effectiveness due to the heterogeneity of the patient population [5]. Stock Performance - Following the FDA's announcement, Replimune's stock price fell by more than 75% on July 22, 2025, reflecting investor reaction to the negative regulatory feedback [5].

Core Viewpoint - A class action lawsuit has been filed against Replimune Group, Inc. for alleged violations of federal securities laws during the specified class period [1][2]. Group 1: Lawsuit Details - The lawsuit seeks to recover damages for all individuals and entities that purchased Replimune securities between November 22, 2024, and July 21, 2025 [2]. - The Complaint alleges that Defendants made materially false and misleading statements regarding the IGNYTE trial's prospects, which were ultimately deemed inadequate by the FDA [3]. Group 2: Next Steps - Investors who suffered losses in Replimune have until September 22, 2025, to request to be appointed as lead plaintiff in the case [4]. - A copy of the Complaint can be reviewed on the law firm's website [4]. Group 3: Legal Representation - The law firm operates on a contingency fee basis, meaning they will only seek reimbursement for expenses and fees if successful in the lawsuit [5]. - Bronstein, Gewirtz & Grossman, LLC is recognized for representing investors in securities fraud class actions and has recovered significant amounts for investors nationwide [6].

Group 1 - A securities class action lawsuit has been filed against Replimune Group, Inc. for alleged violations of federal securities laws during the class period from November 22, 2024, to October 21, 2025 [1][2] - The complaint claims that the defendants made false and misleading statements regarding the IGNYTE trial, which was deemed inadequate by the FDA due to known material issues [2] - Investors are encouraged to contact the firm before the lead plaintiff motion deadline on September 22, 2025, to discuss their rights and interests in the class action [3]