WOBURN, Mass., Oct. 19, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced data from a new ad hoc analysis from the IGNYTE phase 2 cohort of RP1 plus nivolumab was presented by Caroline Robert, M.D., Ph.D., at the European Society for Medical Oncology (ESMO) Congress 2025 being held in Berlin (Poster 1644P). The analysis of acral melanoma patients from the IGNYTE clinical trial s ...

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Replimune (REPL) To Contact Him Directly To Discuss Their Options If you are a long-term stockholder in Replimune between November 22, 2024 and July 21, 2025 and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Marion Passmore directly at (212) 355-4648. NEW YORK, Oct. 08, 2025 (GLOBE NEWSWIRE) -- What’s Happening: Bragar Eagel & Squire, P.C., a nationally r ...

股价表现 - 公司股价在过去三个月内暴跌54.2% [1] - 公司股价年初至今下跌64.2%，而同期行业增长3.6% [4] 监管挫折与原因 - 美国食品药品监督管理局于7月针对公司主要管线资产RP1联合欧狄沃治疗晚期黑色素瘤的生物制品许可申请发出完整回复函 [1] - 监管机构指出IGNYTE研究的数据未能达到其关于充分和良好对照的临床研究标准，使得申请无法以当前形式获批 [2] - 监管机构认为研究结果因患者群体的异质性而难以解读，并指出正在进行的验证性研究在设计上存在缺陷，但未提出安全性担忧 [2] 对公司的影响 - 此次挫折为RP1的监管路径带来重大不确定性，该资产曾被公司定位为高需求肿瘤市场近期的潜在增长动力 [3] - 事件显著延迟了公司推出首款获批产品并建立稳定收入流的机会 [3] - 股价暴跌反映了公司研发时间表受到的近期干扰以及市场对其推进主要项目能力的广泛担忧 [3] 后续进展 - 公司已完成与监管机构的A类会议，讨论针对完整回复函的后续步骤 [6] - 公司正在审阅监管机构的反馈以评估可能的下一步行动，但基于加速批准路径的明确方案尚未确定 [7] - 管理层强调晚期黑色素瘤领域仍存在未满足的医疗需求，计划与监管机构密切合作以确定可行的快速开发路径 [7] 研发管线与项目背景 - 针对RP1联合欧狄沃的申请于2025年1月被监管机构接受并纳入优先审评 [8] - 申请基于IGNYTE研究的主要分析数据，该研究显示联合疗法在抗PD-1治疗失败的黑色素瘤患者中具有有利的风险获益特征 [8] - 除黑色素瘤外，公司还在IGNYTE研究中探索该联合疗法用于多种非黑色素瘤皮肤癌适应症，并评估RP1单药治疗实体器官移植受者的皮肤癌 [11] - 公司临床阶段管线中拥有第二个候选药物，目前正处于针对皮肤癌和肝癌适应症的两项独立中期研究中 [11]

NEW YORK--(BUSINESS WIRE)---- $REPL #ClassAction--Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Replimune Group, Inc. ("Replimune†or the "Company†) (NASDAQ: REPL) and reminds investors of the September 22, 2025 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company. Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgi ...

公司监管进展 - 2025年9月16日Replimune与FDA完成A类会议讨论RP1生物制剂许可申请但加速批准路径尚未确定[1] - 2025年7月22日FDA针对RP1治疗晚期黑色素瘤的BLA发出完全回应函（CRL）实质拒绝批准[2] 股价波动情况 - 2025年9月18日公司股价盘中暴跌约45%[1] - 2025年7月22日FDA拒绝批准导致单日股价暴跌77%市值蒸发数十亿美元[2] 法律诉讼指控 - 指控公司夸大RP1药物成功可能性误导投资者[3][4] - 指控公司未披露IGNYTE试验存在患者异质性等根本缺陷[6][7] - 指控公司未披露FDA可能认定试验设计和数据不符合批准要求[7] 试验设计问题 - FDA认定IGNYTE试验并非"充分设计或控制的调查"无法提供有效性实质证据[3] - FDA指出试验存在患者群体异质性问题导致结果难以解读[6] - FDA对计划中的验证性试验设计存在异议[7] 投资者法律程序 - 集体诉讼期间为2024年11月22日至2025年7月21日[2] - 主要原告申请截止日为2025年9月22日[2]

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses Exceeding $50,000 In Replimune To Contact Him Directly To Discuss Their Options If you suffered losses exceeding $50,000 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] NEW YORK, Sept. 21, 2025 (GL ...

NEW YORK, Sept. 21, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Replimune Group, Inc. (NASDAQ: REPL) between November 22, 2024 and July 21, 2025, both dates inclusive (the “Class Period”), of the important September 22, 2025 lead plaintiff deadline in the securities class action first filed by the Firm. SO WHAT: If you purchased Replimune securities during the Class Period you may be entitled to compensation without payment of any out ...

NEW YORK--(BUSINESS WIRE)--Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Replimune Group, Inc. (NASDAQ: REPL) between November 22, 2024 and July 21, 2025, both dates inclusive (the "Class Period†), of the important September 22, 2025 lead plaintiff deadline in the securities class action first filed by the Firm. So what: If you purchased Replimune securities during the Class Period you may be entitled to compensation without payment of any out of po. ...

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NEW YORK, Sept. 19, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Replimune Group, Inc. ("Replimune Group, Inc." or the "Company") (NASDAQ: REPL) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Replimune Group, Inc. investors who were adversely affected by alleged securities fraud between November 22, 2024 and July 21, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/p ...