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 [1][3]. Group 1: Legal Investigation - The law firm is encouraging investors who suffered losses in Replimune between November 22, 2024, and July 21, 2025, to contact them regarding their legal rights [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 [1][5]. Group 2: Allegations Against Replimune - The complaint alleges that Replimune and its executives overstated the prospects of the IGNYTE trial, which the FDA deemed inadequate and not well-controlled [3]. - The lawsuit claims that the misleading statements about Replimune's business and operations led to investor damages when the true details were revealed [3]. Group 3: Market Reaction - Following the announcement of a Complete Response Letter from the FDA regarding the Biologics License Application for RP1, Replimune's stock fell over 73% during intraday trading on July 22, 2025 [4].

Core Viewpoint - Replimune Group, Inc. is facing a class action lawsuit due to alleged misleading statements regarding the prospects of its IGNYTE trial, which led to a significant stock price drop after the FDA's response [4][5]. Group 1: Company Overview - Replimune is a clinical-stage biotechnology company focused on developing and commercializing oncolytic immunotherapies for cancer treatment [3]. Group 2: Legal Allegations - The class action lawsuit claims that Replimune's management made false and misleading statements about the IGNYTE trial, which they knew or should have known were overstated [4]. - The lawsuit highlights that the FDA deemed the IGNYTE trial inadequate and not well-controlled, impacting the company's credibility [4]. Group 3: Financial Impact - Following the FDA's issuance of a Complete Response Letter regarding the Biologics License Application for RP1, Replimune's stock price plummeted by over 77% [5].

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].

NEW YORK, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Replimune Group, Inc. (“Replimune” or the “Company”)(NASDAQ: REPL). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. The class action concerns whether Replimune and certain of ...

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 [3][5][7] Group 1: Legal Investigation and Class Action - The 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 complaint alleges that Replimune and its executives made false and misleading statements regarding the IGNYTE trial, which the FDA deemed inadequate [5][7] 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 [6][7] - Following the announcement of the CRL, Replimune's stock price fell over 73% during intraday trading on the same day [7] 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 [4] - The firm is actively seeking information regarding Replimune's conduct from whistleblowers, former employees, and shareholders [9]

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Replimune To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in Replimune between November 22, 2024 and July 21, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] On this news, Replimune common stock plummeted o ...

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 [2][5]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi is encouraging investors who suffered losses in Replimune between November 22, 2024, and July 21, 2025, to discuss their legal rights [1][2]. - 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][6]. - The lead plaintiff is defined as the investor with the largest financial interest who directs the litigation on behalf of the class [6]. 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 [4]. - It is claimed that the defendants overstated the trial's prospects, leading to the FDA deeming it inadequate, which resulted in misleading statements about the company's business and operations [4]. Group 3: Stock Market Impact - Following the FDA's Complete Response Letter on July 22, 2025, Replimune's stock plummeted over 73% during intraday trading [5].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Replimune Group, Inc. due to significant stock losses following a negative FDA response regarding its drug application [3][5][6]. Group 1: Legal Investigation and Claims - 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 complaint alleges that Replimune and its executives made false or misleading statements regarding the IGNYTE trial, which the FDA deemed inadequate [5]. Group 2: Impact of FDA Response - On July 22, 2025, Replimune received a Complete Response Letter from the FDA, indicating that the application for RP1 was not approvable in its current form due to inadequacies in the IGNYTE trial [6]. - Following the FDA's announcement, Replimune's stock price fell over 73% during intraday trading on the same day [7]. Group 3: Company Background - Faruqi & Faruqi, LLP is a national securities law firm with a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [4].

Group 1 - A securities class action lawsuit has been filed against Replimune Group, Inc. alleging possible securities fraud or other unlawful business practices [5] - The lawsuit covers a class period from November 22, 2024, to July 21, 2025, with a lead plaintiff deadline of September 22, 2025 [5] - The trigger event for the lawsuit was the FDA's Complete Response Letter rejecting Replimune's Biologics License Application for RP1, citing inadequate clinical evidence from the IGNYTE trial [5] Group 2 - Following the FDA's announcement, Replimune's stock experienced a significant decline of 77.24%, closing at $2.81 per share after a drop of $9.52 [5]

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].