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].

Core Viewpoint - A class action lawsuit has been filed against Replimune Group, Inc. for allegedly misleading investors regarding the viability of its IGNYTE trial, which has resulted in significant stock price decline following a complete response letter from the FDA [1][2][3]. Allegations - The lawsuit claims that Replimune's management overstated the prospects of the IGNYTE trial, which the FDA deemed inadequate and not well-controlled [2]. - Defendants are accused of making materially false and misleading statements about the company's business and operations throughout the class period [2]. Stock Impact - Following the announcement of the complete response letter from the FDA on July 22, 2025, Replimune's stock price fell by $9.52 per share, representing a 77.24% decrease, closing at $2.80 per share [3]. Class Action Participation - Shareholders interested in participating as lead plaintiffs must file their papers by September 22, 2025, but they can also remain absent class members without taking action [4].

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]

Core Points - A shareholder class action lawsuit has been filed against Replimune Group, Inc. alleging that the company made materially false and misleading statements regarding the IGNYTE trial's prospects [1] - The lawsuit claims that the defendants overstated the trial's prospects despite known material issues, leading the FDA to deem the trial inadequate and not well-controlled [1] - As a result of these actions, the statements made by the defendants about Replimune's business, operations, and prospects were considered materially false and misleading [1] Legal Information - Shareholders who purchased Replimune shares between November 22, 2024, and July 21, 2025, and experienced significant losses are encouraged to discuss their legal rights [2] - The deadline to request to be appointed as lead plaintiff in the case is September 22, 2025 [3] - Holzer & Holzer, LLC is a law firm specializing in securities litigation and has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Replimune Group, Inc. following a significant drop in stock price after the FDA issued a Complete Response Letter regarding its Biologics License Application for RP1 [3][6][7] Group 1: Legal Investigation - The law firm 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 [3][8] - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [4] Group 2: Allegations Against Replimune - The complaint alleges that Replimune and its executives violated federal securities laws by making false or misleading statements regarding the IGNYTE trial's prospects [5] - It is claimed that the defendants overstated the trial's prospects, leading to the FDA deeming it inadequate and not well-controlled [5][6] - Following the FDA's announcement, Replimune's stock plummeted over 73% during intraday trading on July 22, 2025 [7] Group 3: Company Communication - On July 22, 2025, Replimune announced it received a Complete Response Letter from the FDA, indicating that the application could not be approved in its current form [6] - The FDA's response highlighted that the IGNYTE trial did not provide substantial evidence of effectiveness [6]

Core Viewpoint - A class action lawsuit has been filed against Replimune Group, Inc. for alleged violations of securities laws, specifically related to misleading statements about the company's clinical trial results [1][4]. Group 1: Lawsuit Details - The lawsuit pertains to investors who purchased Replimune's securities between November 22, 2024, and July 21, 2025 [2]. - The Schall Law Firm is representing the investors and encourages those who suffered losses to participate in the lawsuit [5]. Group 2: Allegations Against the Company - The complaint alleges that Replimune made false and misleading statements regarding the IGNYTE trial for RP1 (vusolimogene oderparepvec) [4]. - It is claimed that the company overstated the prospects of the trial and was aware of material issues that could lead to the FDA deeming the trial inadequate [4]. - As a result of these misleading statements, investors experienced financial damages when the truth about the company's situation was revealed [4].