Key Takeaways Replimune shares fell 54.2% in three months after the FDA issued a CRL against its RP1 BLA in July.The FDA cited shortcomings in the IGNYTE study data but noted no safety concerns with RP1.Replimune met with the FDA to discuss next steps, with a clear regulatory path still uncertain.Replimune Group’s (REPL) share price tumbled 54.2% over the past three months. The massive setback was observed after the FDA issued a complete response letter (CRL) in July, against the biologics license applicati ...

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. ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

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 ...

Key Points It was the subject of a recommendation downgrade from an analyst. Another pundit reiterated his neutral stance on the company. 10 stocks we like better than Replimune Group › One day after enduring a nearly 40% decline in its share price, bitoech Replimune (NASDAQ: REPL) was also down on Friday, although nowhere near as steeply. The company's stock was in the red by almost 7%, which didn't look so hot next to the S&P 500's (SNPINDEX: ^GSPC) gain of 0.5%. A recommendation downgrade from a ...

We recently published 10 Stocks Losing Big Amid Market Boom. Replimune Group, Inc. (NASDAQ:REPL) is one of the best performers on Thursday. Replimune extended losses to a second consecutive day on Thursday, slashing 39.40 percent to close at $3.46 apiece after failing to clear regulatory challenges for its treatment candidate for melanoma. In a statement, Replimune Group, Inc. (NASDAQ:REPL) said it met with the US Food and Drug Administration on Tuesday to discuss the agency’s complete response letter fo ...