Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026WOBURN, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on ...

Core Insights - Replimune Group's share price has decreased by 54.2% over the past three months following the FDA's complete response letter (CRL) regarding its biologics license application (BLA) for RP1 in combination with Opdivo for advanced melanoma treatment [1][5] - The FDA's CRL was based on the inadequacy of data from the IGNYTE study, which did not meet the standards for a well-controlled clinical investigation, although no safety concerns were raised [2][5] - The setback has created significant uncertainty regarding the regulatory path for RP1, delaying Replimune's prospects of launching its first approved product and establishing a revenue stream [3][4] Company Developments - Replimune has completed a Type A meeting with the FDA to discuss the CRL and is currently reviewing the agency's feedback to determine next steps, although a clear regulatory path remains uncertain [6][7] - The BLA for RP1 in combination with Opdivo was initially accepted for review under the FDA's Priority Review pathway in January 2025, based on the IGNYTE study's primary analysis data [8] - Replimune is also exploring RP1 for other indications, including non-melanoma skin cancers and as a monotherapy for solid organ transplant recipients with skin cancers [11] Market Context - Year-to-date, Replimune's shares have fallen by 64.2%, contrasting with a 3.6% growth in the broader industry [4] - The company is facing challenges in delivering on its lead program, which has raised broader investor concerns about its future performance [3]

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 [4][6]. 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 rights [1][4]. - 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 [4][8]. Group 2: Allegations Against Replimune - The complaint alleges that Replimune and its executives made false and misleading statements regarding the IGNYTE trial, which the FDA deemed inadequate [6][7]. - Following the FDA's Complete Response Letter on July 22, 2025, Replimune's stock price fell over 73% during intraday trading, indicating significant investor losses [7]. Group 3: Firm Background - 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 [5].

Core Viewpoint - Replimune Group, Inc. has completed a Type A meeting with the FDA regarding the complete response letter for its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment [1][2] Company Overview - Replimune Group, Inc. is a clinical stage biotechnology company focused on developing novel oncolytic immunotherapies, founded in 2015 and headquartered in Woburn, MA [4] - The company's lead product candidate, RP1 (vusolimogene oderparepvec), is engineered from a proprietary strain of herpes simplex virus designed to enhance tumor killing and activate systemic anti-tumor immune responses [3][4] FDA Interaction - The company is currently evaluating FDA feedback from the recent meeting to determine the next steps, with no clear path forward under the accelerated approval pathway established yet [2] - The CEO emphasized the unmet need in advanced melanoma and the favorable risk-benefit profile of RP1 observed in the IGNYTE trial, indicating a commitment to work with the FDA for a timely resolution [3]

Group 1 - The DJS Law Group has announced a class action lawsuit against Replimune Group, Inc. for violations of the Securities Exchange Act of 1934, specifically §§10(b) and 20(a) and Rule 10b-5 [1][2] - The class period for the lawsuit is from November 22, 2024, to July 21, 2025, with a deadline for participation set for September 22, 2025 [2] - The complaint alleges that Replimune made false and misleading statements regarding the IGNYTE trial for RP1, indicating that the company was aware of serious issues that could lead to FDA concerns about trial controls [2] Group 2 - Shareholders who purchased shares during the specified class period are encouraged to contact the DJS Law Group for potential lead plaintiff appointments, although this is not a requirement for recovery [2][3] - The DJS Law Group specializes in securities class actions and corporate governance litigation, focusing on enhancing investor returns through advocacy [4]

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].

Core Viewpoint - A class action lawsuit has been filed against Replimune Group, Inc. concerning allegations of securities fraud and unlawful business practices related to the company's recent FDA response regarding its drug application [1][2]. Group 1: Lawsuit Details - The class action lawsuit is focused on whether Replimune and certain officers or directors engaged in securities fraud or other unlawful business practices [2]. - Investors have until September 22, 2025, to request to be appointed as Lead Plaintiff if they purchased Replimune securities during the Class Period [2]. Group 2: FDA Response and Stock Impact - On July 22, 2025, Replimune received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for RP1 in combination with nivolumab for advanced melanoma [4]. - The CRL indicated that the FDA could not approve the application in its current form, citing inadequacies in the IGNYTE trial and issues with the patient population's heterogeneity [4]. - Following the announcement, Replimune's stock price fell by $9.52 per share, or 77.24%, closing at $2.81 per share on the same day [4].

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]