Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is intended to provide informational content and should not be viewed as an exhaustive an ...

Key Points The biotech received the good news it was hoping for from a top national regulator. This concerned RP1, its advanced melanoma drug. 10 stocks we like better than Replimune Group › Biotech stocks can be volatile, a tendency that was very much in Replimune Group's (NASDAQ: REPL) favor on Monday. The biotech's stock had more than doubled in late-session action, thanks to some very positive news on the regulatory front. Its rise was easily eclipsing the S&P 500 index, which at that point was ...

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, Inc. presented new data from the IGNYTE phase 2 cohort of RP1 plus nivolumab at the ESMO Congress 2025, highlighting promising results for acral melanoma patients [1][2] Group 1: Clinical Trial Results - The analysis showed an objective response rate of 44% (8 out of 18 patients) for acral melanoma patients treated with RP1 and nivolumab, with a median duration of response of 11.9 months [2] - The safety profile of the treatment was favorable, with mostly transient grade 1 and 2 treatment-related adverse events [2] Group 2: Background on Acral Melanoma - Acral melanoma is a rare and aggressive form of cutaneous melanoma, accounting for 2-3% of all melanoma cases, often presenting poor outcomes and limited treatment options [3] - Current therapies, including immune checkpoint inhibitors, typically do not yield effective results for acral melanoma, especially after progression on first-line therapy [3] Group 3: Ongoing and Future Trials - The IGNYTE-3 phase 3 trial is currently recruiting participants to evaluate RP1 plus nivolumab against physician's choice of treatment for melanoma that has progressed on anti-PD1 and anti-CTLA-4 therapy [4] - An additional poster on the efficacy and safety of RP1 plus nivolumab in non-melanoma skin cancers is also being presented at the ESMO Congress [4] Group 4: About RP1 - RP1 (vusolimogene oderparepvec) is Replimune's lead product candidate, engineered from a proprietary strain of herpes simplex virus, designed to enhance tumor killing and activate systemic anti-tumor immune responses [6] Group 5: Company Overview - Replimune Group, Inc., founded in 2015 and headquartered in Woburn, MA, aims to transform cancer treatment through innovative oncolytic immunotherapies [7] - The company's RPx platform is based on a potent HSV-1 backbone, intended to maximize immunogenic cell death and induce a systemic anti-tumor immune response [7]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Replimune Group, Inc. due to a class action complaint alleging breaches of fiduciary duties by the board of directors during the specified class period [1][2]. Group 1: Lawsuit Details - The lawsuit claims that defendants made false and misleading statements regarding the IGNYTE trial, which the FDA deemed inadequate and not well-controlled [2]. - It is alleged that the defendants overstated the trial's prospects, leading to materially false and misleading statements about Replimune's business and operations [2]. Group 2: Next Steps for Investors - Long-term stockholders of Replimune are encouraged to contact Bragar Eagel & Squire for more information regarding their rights and the ongoing investigation [3]. - The firm offers a no-cost consultation for investors seeking to understand their legal options [3]. Group 3: About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm that represents investors in complex litigation across various courts in the United States [4].

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 - Replimune Group, Inc. is under investigation for potential claims related to a federal securities class action, with a deadline for investors to seek lead plaintiff status set for September 22, 2025 [1] Group 1 - Faruqi & Faruqi, LLP, a prominent national securities law firm, is leading the investigation into Replimune Group, Inc. [1] - The investigation is focused on potential claims against the company, indicating possible legal challenges ahead [1] - Investors are reminded of the critical deadline to participate in the class action, emphasizing the urgency for affected parties [1]

Core Viewpoint - Replimune Group, Inc. experienced a significant stock price decline of approximately 45% following the announcement of an FDA meeting regarding its Biologics License Application for the drug candidate RP1, with no clear path for accelerated approval established [1] Group 1: FDA Interaction and Stock Impact - On September 16, 2025, Replimune completed a Type A meeting with the FDA to discuss its BLA for RP1, but the FDA did not determine a path forward for accelerated approval [1] - The company's stock plummeted by 77% on July 22, 2025, after the FDA issued a Complete Response Letter rejecting the BLA for RP1, resulting in billions in market value loss [2] - The lawsuit against Replimune claims that the company misled investors about the success of RP1, contributing to the dramatic stock price drop [3][4] Group 2: Legal Proceedings and Allegations - A securities class action lawsuit has been filed against Replimune, with a lead plaintiff deadline set for September 22, 2025, urging affected investors to come forward [2] - The lawsuit alleges that Replimune failed to disclose regulatory concerns that directly led to the stock's collapse, resulting in significant investor losses [4] - Hagens Berman is investigating whether Replimune misrepresented the prospects of the IGNYTE trial, which was deemed inadequately designed by the FDA [5][6] Group 3: Trial Concerns and Management Accountability - The FDA's rejection letter highlighted that the IGNYTE trial was not well-designed, citing issues such as patient heterogeneity and flawed design, which are critical to the integrity of the data [6][7] - The lawsuit claims that Replimune overstated the likelihood of success for the IGNYTE trial, which the FDA found inadequate for approval [7] - The investigation is focused on whether Replimune's management was aware of the trial's fundamental flaws and failed to disclose this information to investors [6]

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 - Rosen Law Firm is reminding investors who purchased Replimune Group, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline for a securities class action lawsuit [1][2]. Group 1: Class Action Details - The Class Period for the Replimune securities class action is from November 22, 2024, to July 21, 2025 [1]. - Investors who purchased Replimune securities during this period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A lead plaintiff must file a motion with the Court by September 22, 2025, to represent other class members in the litigation [3]. Group 2: Case Allegations - The lawsuit alleges that defendants made materially false and misleading statements regarding the IGNYTE trial's prospects, which the FDA deemed inadequate [5]. - It is claimed that the defendants knew or should have known about material issues affecting the trial, leading to misleading statements about Replimune's business and operations [5]. Group 3: Rosen Law Firm's Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest settlement against a Chinese company at the time and being ranked No. 1 for securities class action settlements in 2017 [4]. - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].