SAN FRANCISCO, Aug. 25, 2025 (GLOBE NEWSWIRE) -- Hagens Berman is investigating claims alleged in a new securities class action against Replimune Group, Inc. (NASDAQ: REPL) and its executives after the company's stock plummeted following the FDA’s rejection of its leading cancer drug, RP1. The lawsuit alleges that Replimune misled investors by overstating the drug’s trial data and failing to disclose critical regulatory risks. The filing, known as Jboor v. Replimune Group, Inc., et al., is on behalf of inve ...

NEW YORK, July 30, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Replimune Group, Inc. (NASDAQ: REPL) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Replimune, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/replimune-group-class-action-lawsuit. Investors have until September 22, 2025, to ask the Court to b ...

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 - 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 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 - 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 - 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].

RP1 Clinical Trial Results & Opportunities - In anti-PD1 failed melanoma patients, RP1 plus Nivolumab achieved an Objective Response Rate (ORR) of 32.9% and a median Duration of Response (mDoR) of 33.7 months[78] - In responders, responses in non-injected lesions occurred with similar frequency and depth as injected lesions, indicating systemic benefit[78] - Patients with deep/visceral (+/- superficial) injections had numerically higher response rates vs those who received superficial injections only[78] - In solid organ transplant patients with locally advanced CSCC, RP1 monotherapy achieved an ORR of 34.6% and a Disease Control Rate (DCR) of 65.4%[220] - In a study of resectable cutaneous Squamous Cell Carcinoma (cSCC), RP1 monotherapy resulted in a 100% overall response rate, with 83% achieving pathological complete response[214] RPx Platform Expansion & Pipeline - The company is planning RPx expansion into additional skin cancers, liver and thoracic primary/metastatic cancers[174] - A confirmatory Phase 3 trial (IGNYTE-3) is underway in melanoma, randomizing patients to RP1 + Nivolumab vs Treatment of Physician's Choice[179] - A registrational REVEAL study is ongoing for RP2 in metastatic Uveal Melanoma, comparing RP2 + Nivolumab to Ipilimumab + Nivolumab[243] - RP2 is being evaluated in liver primary/metastases, including a cohort with RP2 + Bevacizumab + Atezolizumab in 2L PD-(L)1 failed Hepatocellular Carcinoma (HCC)[246] Commercialization & Market Opportunity - The company estimates ~10,000 addressable patients across lines of therapy for RP1 in the US melanoma market[111] - The company estimates RPx has the potential to reach up to ~125,000 patients in the US across various cancer types[251] - The company has hired and trained a commercial organization of ~60 customer-facing team members[108]

Core Insights - Replimune Group, Inc. presented data on RP1 plus nivolumab at the 2025 ASCO Annual Meeting, highlighting robust responses in both injected and non-injected lesions, with deep injections showing higher response rates compared to superficial injections [1][2][4] Group 1: Clinical Trial Findings - The IGNYTE clinical trial involved 140 anti-PD-1 failed melanoma patients, showing an objective response rate (ORR) of 32.9% and a complete response rate of 15.0% [4] - Landmark overall survival (OS) rates at 1, 2, and 3 years were reported as 75.3%, 63.3%, and 54.8% respectively, with median OS not yet reached [4] - Deep injections resulted in higher ORR: 29.8% for superficial injections, 42.9% for deep/visceral plus superficial injections, and 40.9% for deep/visceral injections only [4] Group 2: Safety and Tolerability - RP1 injections into the liver and lung were generally well tolerated, with few organ-specific adverse events [4] - No bleeding events were reported after liver injections, and lung injections had low rates of pneumothorax, typically of low grade and manageable [4] - Standard disinfection procedures were confirmed sufficient for RP1 clean-up, with no transmission of RP1 reported to date [10] Group 3: Product Information - RP1 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 [6][8] - The RPx platform aims to induce a strong and durable systemic response while being synergistic with various cancer treatment modalities [8]