NEW YORK, July 24, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, announces it has filed a class action lawsuit on behalf of purchasers of securities of Replimune Group, Inc. (NASDAQ: REPL) between November 22, 2024 and July 21, 2025, both dates inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 22, 2025 in the securities class action first filed by the Firm. ...

Core Points - The Replimune Group, Inc. is facing a class action lawsuit due to alleged violations of the Securities Exchange Act of 1934 by the company and its executives during the Class Period from November 22, 2024, to July 21, 2025 [1][3] - The lawsuit claims that Replimune made misleading statements regarding the IGNYTE trial, which the FDA deemed inadequate, leading to a significant drop in stock price [3][4] Company Overview - Replimune is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with its lead product candidate being RP1 (vusolimogene oderparepvec) [2] Legal Allegations - The class action lawsuit alleges that Replimune and its executives overstated the prospects of the IGNYTE trial, which resulted in the FDA's Complete Response Letter indicating that the trial was not well-controlled [3][4] - Following the FDA's announcement on July 22, 2025, Replimune's stock price fell by more than 77% [4] Class Action Process - Investors who purchased Replimune securities during the Class Period can seek to be appointed as lead plaintiff in the class action lawsuit, representing the interests of all class members [5]

Core Viewpoint - Replimune Group, Inc. is under investigation for possible securities fraud following a significant stock decline after the FDA's rejection of its Biologics License Application for RP1 [1][3][4] Group 1: Company Overview - Replimune Group, Inc. is a biotechnology company focused on developing treatments for advanced melanoma [3] - The company received a Complete Response Letter (CRL) from the FDA regarding its application for RP1 in combination with nivolumab [3][4] Group 2: Regulatory Developments - The FDA stated that the IGNYTE trial was not adequate for providing substantial evidence of effectiveness, leading to the rejection of the application [4] - The CRL was issued on July 22, 2025, prior to market open [3] Group 3: Market Reaction - Following the FDA announcement, Replimune's stock fell sharply by $9.52 per share, representing a decline of over 77%, closing at $2.80 on July 22, 2025 [4] Group 4: Legal Actions - The Portnoy Law Firm has initiated an investigation and may file a class action on behalf of investors who lost money due to the stock decline [1][2] - Investors are encouraged to contact the law firm for a complimentary case evaluation regarding their legal rights [2][5]

Core Viewpoint - Replimune Group, Inc. is under investigation for potential violations of federal securities laws following a significant decline in stock price after the FDA's response regarding its lead product candidate RP1 [1][4]. Company Overview - Replimune is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer treatment, with RP1 as its lead product candidate aimed at melanoma [2]. Clinical Trial Results - On June 6, 2024, Replimune announced positive top-line results from the IGNYTE Phase 1/2 clinical trial for RP1 in combination with nivolumab [2]. - The company repeatedly promoted the results of the IGNYTE trial, but the trial design was criticized for not being adequate to produce reliable results [3]. Regulatory Response - On July 22, 2025, Replimune received a Complete Response Letter from the FDA, indicating that the IGNYTE trial was not considered adequate and well-controlled, leading to a significant stock price drop of over 75% [4]. - The FDA specifically noted that the trial's results could not be adequately interpreted due to the heterogeneity of the patient population [4].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Replimune Group, Inc. due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Replimune Group, Inc. received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for RP1, indicating that the application cannot be approved in its current form [3]. - The FDA stated that the IGNYTE trial does not provide substantial evidence of effectiveness, which contributed to a significant drop in Replimune's stock price [3]. - Following the announcement of the CRL, Replimune's common stock fell by $9.52 per share, representing a decline of over 77%, closing at $2.80 on July 22, 2025 [3]. Group 2: Legal Action and Investor Rights - Investors who purchased Replimune securities may be entitled to compensation through a class action lawsuit, with no out-of-pocket fees due to a contingency fee arrangement [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to the misleading information [2]. - The firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [4].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Replimune Group, Inc. following a significant stock price drop after the FDA issued a Complete Response Letter regarding its Biologics License Application for RP1 [1][3]. Company Summary - Replimune Group, Inc. (NASDAQ: REPL) faced a major setback when the FDA issued a Complete Response Letter on July 22, 2025, indicating that the application for RP1 in combination with nivolumab for advanced melanoma could not be approved in its current form [3]. - The FDA's letter highlighted that the IGNYTE trial was not considered adequate and well-controlled, lacking substantial evidence of effectiveness due to the heterogeneity of the patient population [3]. - Following the announcement, Replimune's stock price plummeted by $9.52, or 77.24%, closing at $2.81 per share [3]. Legal Investigation - Bragar Eagel & Squire, P.C. is encouraging investors who suffered losses from Replimune's stock decline to contact them to discuss potential legal rights and claims [1][4]. - The law firm is specifically looking into whether Replimune violated federal securities laws or engaged in unlawful business practices [1].

Core Viewpoint - Replimune Group, Inc. is under investigation for potential violations of federal securities laws following a significant decline in its stock price after receiving a Complete Response Letter from the FDA regarding its lead product RP1 [1][3]. Company Summary - Replimune received a Complete Response Letter from the FDA on July 22, 2025, indicating that its IGNYTE trial was not considered adequate for demonstrating the effectiveness of RP1 in combination with nivolumab for advanced melanoma [3]. - Following the FDA's announcement, Replimune's stock price fell by $9.52, or approximately 77.24%, closing at $2.81 per share [3]. Legal Investigation Summary - Kirby McInerney LLP is investigating potential claims against Replimune and its officers for possible violations of federal securities laws and other unlawful business practices [1][4].

Core Points - Holzer & Holzer, LLC is investigating Replimune Group, Inc. for potential compliance issues with federal securities laws following the receipt of a Complete Response Letter from the FDA regarding its Biologics License Application for RP1 [1] - The FDA's Complete Response Letter indicated that the IGNYTE trial was not considered adequate to provide substantial evidence of effectiveness for the treatment of advanced melanoma [1] - Following the announcement of the CRL, Replimune's stock price experienced a decline [1] Company Information - Replimune Group, Inc. is focused on developing treatments for advanced melanoma, specifically through the use of RP1 in combination with nivolumab [1] - The company is publicly traded on NASDAQ under the ticker REPL [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation, representing shareholders and investors in class action and derivative litigation [3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Core Viewpoint - Replimune Group, Inc. announced that the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of RP1 in combination with nivolumab for advanced melanoma treatment, indicating that the application cannot be approved in its current form [1][2] Group 1: FDA Response - The CRL states that the IGNYTE trial is not considered an adequate and well-controlled clinical investigation providing substantial evidence of effectiveness [2] - The FDA highlighted issues related to the heterogeneity of the patient population and the confirmatory trial study design that need to be addressed [2] - Importantly, the CRL did not raise any safety issues regarding the application [2] Group 2: Company Response - The company plans to request a Type A meeting with the FDA, expecting it to be granted within 30 days, to discuss a path forward for accelerated approval of RP1 [3] - The CEO expressed surprise and disappointment regarding the FDA's decision, noting that the issues raised in the CRL were not previously mentioned during mid- and late-cycle reviews [4] - The company remains confident that RP1 in combination with nivolumab can provide substantial benefits to advanced melanoma patients [4] Group 3: Product Information - RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate, engineered from a proprietary strain of herpes simplex virus, designed to maximize tumor killing potency and activate a systemic anti-tumor immune response [5] - The RPx platform aims to induce immunogenic cell death and alter the tumor microenvironment to promote a strong systemic immune response [6]

RP1: IGNITING A SYSTEMIC IMMUNE RESPONSE TO CANCER - IGNYTE trial showed an objective response rate (ORR) of 32.1% by investigator assessment and 33.6% by independent central review in anti-PD1 failed melanoma patients [24, 37] - In the IGNYTE trial, 14.7% of patients achieved a complete response (CR) [24] - In the IGNYTE trial, 17.9% of patients achieved a partial response (PR) [24] - In the IGNYTE trial, 70.4% of responding patients experienced responses in non-injected lesions, demonstrating systemic benefit [28] - Responses in the IGNYTE trial are durable, with 84.2% lasting >6 months, 74.9% lasting >12 months, and 65.2% lasting >18 months [31] - The median duration of response (DOR) in the IGNYTE trial is 36.6 months [31] - In the ARTACUS clinical trial, RP1 monotherapy showed an ORR of 34.8% and a CRR of 21.7% in solid organ transplant (SOT) patients with non-melanoma skin cancers (NMSC) [51] - In locally advanced CSCC, the complete response rate more than doubled for RP1+cemiplimab vs cemiplimab alone (48.1% vs 22.6%) [71] RP2: FOCUSED ON RARE CANCERS - In uveal melanoma, RP2 monotherapy and in combination with nivolumab showed an ORR of 29.4% [90] Financial Status - The company has a strong financial position with cash of $420.7 million as of March 31, 2024, providing a cash runway into the second half of 2026 [114]