--- title: "Sarepta 醫療（SRPT）宣佈重組及 ELEVIDYS 黑框警告，歐洲藥品管理局建議拒絕其營銷授權，證券集體訴訟正在進行中——Hagens Berman" description: "Sarepta 醫療（SRPT）宣佈了一項重大重組，包括裁減 36% 的員工，以每年節省 4 億美元。由於安全問題，FDA 對其基因治療藥物 ELEVIDYS 強制要求加貼黑框警告。針對該公司誤導投資者關於該藥物安全性和有效性的指控，目前正在進行證券集體訴訟。歐洲藥品管理局也建議拒絕 ELEVIDYS 的市場授權，理由是有效性問題。隨着這些事態的發展，股價已顯著下跌" type: "news" locale: "zh-HK" url: "https://longbridge.com/zh-HK/news/251505660.md" published_at: "2025-08-04T19:40:30.000Z" --- # Sarepta 醫療（SRPT）宣佈重組及 ELEVIDYS 黑框警告，歐洲藥品管理局建議拒絕其營銷授權，證券集體訴訟正在進行中——Hagens Berman > Sarepta 醫療（SRPT）宣佈了一項重大重組，包括裁減 36% 的員工，以每年節省 4 億美元。由於安全問題，FDA 對其基因治療藥物 ELEVIDYS 強制要求加貼黑框警告。針對該公司誤導投資者關於該藥物安全性和有效性的指控，目前正在進行證券集體訴訟。歐洲藥品管理局也建議拒絕 ELEVIDYS 的市場授權，理由是有效性問題。隨着這些事態的發展，股價已顯著下跌 SAN FRANCISCO, Aug. 04, 2025 (GLOBE NEWSWIRE) -- On July 16, 2025, Sarepta Therapeutics (**NASDAQ: SRPT**) announced a major restructuring that involves, in part, a 36% workforce reduction (500 employees) and other steps to annually save about $400 million. The company also agreed with the FDA to include a black box warning of acute liver injury and acute liver failure in Sarepta’s ELEVIDYS label. ELEVIDYS is the company’s gene therapy drug intended to treat a limited category of people with Duchenne muscular dystrophy. The development comes in the wake of a securities class action styled *Dolgicer v. Sarepta Therapeutics, Inc., et al.*, No. 1:25-cv-05317 (S.D.N.Y.), which seeks to represent investors who purchased or otherwise acquired Sarepta securities between June 22, 2023 and June 24, 2025. National shareholders rights firm Hagens Berman continues to investigate the lawsuit’s legal claims and urges Sarepta investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys. **Class Period:** June 22, 2023 – June 24, 2025 **Lead Plaintiff Deadline:** Aug. 25, 2025 **Visit:** www.hbsslaw.com/investor-fraud/srpt **Contact the Firm Now:** SRPT@hbsslaw.com **844-916-0895** **Sarepta Therapeutics, Inc. (SRPT) Securities Class Action** The lawsuit challenges the safety and efficacy disclosures made by Sarepta regarding its gene therapy, ELEVIDYS. The complaint, filed on behalf of investors, alleges the company misled them by portraying ELEVIDYS as a safe and effective treatment with a clear path to broader regulatory approval, while withholding crucial information about significant risks. According to the lawsuit, Sarepta conditioned investors to believe the therapy was ready for wider use without disclosing several key facts. The complaint claims the company failed to reveal that ELEVIDYS posed significant safety risks to patients and that its clinical trial protocols were inadequate to detect severe side effects. Furthermore, the lawsuit alleges Sarepta knew the severity of these adverse events would likely lead to regulatory scrutiny, trial halts, and a greater risk to both current and expanded approvals for the drug. The complaint outlines a timeline where investors say they began to learn the truth. On March 18, 2025, Sarepta issued a safety update revealing that a non-ambulatory patient in an ELEVIDYS trial had died. Then, on April 4, 2025, the company disclosed that EU authorities had requested a review of the patient death and that Sarepta had halted recruitment and dosing in some ELEVIDYS studies. A second death was announced on June 15, 2025, from acute liver failure in another non-ambulatory patient. This led Sarepta to suspend shipments of ELEVIDYS for this patient group and pause dosing in one of its clinical studies. Finally, on June 24, 2025, the FDA issued a safety communication confirming its investigation into the risk of acute liver failure associated with ELEVIDYS treatment, citing the two reported deaths. Each of these disclosures, the lawsuit contends, triggered a sharp drop in Sarepta's stock price. The complaint alleges these events prove that Sarepta's prior statements were false and misleading, and that the company failed to disclose material information to investors. **Sarepta Faces New Scrutiny as European Regulators Question ELEVIDYS’s Efficacy** After the filing of the complaint, on July 25, 2025, *Investor’s Business Daily* reported that the European Medicines Agency (“EMA”) rejected ELEVIDYS due to effectiveness questions. According to *IBD*, “\[p\] atients didn’t show a statistically significant benefit on North Star Ambulatory Assessment a year after their gene therapy infusion\[,\]” explaining that “NSAA measures functional motor skills in ambulant children with Duchenne muscular dystrophy\[.\]” This news drove the price of Sarepta shares significantly lower again. **Hagens Berman’s Investigation** “We’re investigating whether Sarepta may have misled investors about the safety and efficacy of—and potential future revenues from—its muscular dystrophy gene therapies,” said Reed Kathrein, the Hagens Berman partner leading the investigation. If you invested in Sarepta and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now » If you’d like more information and answers to frequently asked questions about the Sarepta case and our investigation, read more » **Whistleblowers:** Persons with non-public information regarding Sarepta should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at **844-916-0895** or email SRPT@hbsslaw.com . About Hagens Berman Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. Contact: Reed Kathrein, 844-916-0895 ### Related Stocks - [SRPT.US - Sarepta醫療](https://longbridge.com/zh-HK/quote/SRPT.US.md) ## Related News & Research | Title | Description | URL | |-------|-------------|-----| | Sarepta 因獲得新西蘭監管機構批准開始亨廷頓病試驗而股價上漲 | Sarepta Therapeutics 的股票在盤前交易中上漲 3%，至 20.92 美元，此前該公司在新西蘭獲得了啓動 SRP-1005 的人體試驗的監管批准，這是一種針對亨廷頓舞蹈症的實驗性治療。該早期試驗將招募約 24 名參與者，重 | [Link](https://longbridge.com/zh-HK/news/274824082.md) | | Sarepta 醫療｜8-K：2025 財年 Q4 營收 3.7 億美元不及預期 | | [Link](https://longbridge.com/zh-HK/news/272301520.md) | | 展望未來：8 位分析師對 Sarepta Therapeutics 的預測 | 在過去三個月中，8 位分析師對 Sarepta Therapeutics（NASDAQ:SRPT）進行了評估，顯示出從看漲到看跌的情緒範圍。12 個月的平均目標價為 22.25 美元，最高為 45.00 美元，最低為 5.00 美元。最近的 | [Link](https://longbridge.com/zh-HK/news/272548848.md) | | 增長前景放緩和監管風險加劇導致對 Sarepta Therapeutics 的賣出評級 | Needham 分析師 Gil Blum 重申了對 Sarepta Therapeutics (SRPT) 的賣出評級，原因是對其增長前景和監管風險的擔憂。儘管 2025 年的收入指引符合預期，但缺乏具體的 2026 年指引引發了對潛在收入 | [Link](https://longbridge.com/zh-HK/news/272438221.md) | | Sarepta 醫療第四季度初步淨產品收入未能達到預期 | Sarepta Therapeutics 報告了初步的第四季度淨產品收入為 3.696 億美元，低於分析師預期的 3.8207 億美元。收入受到嚴重流感季節和重新安排的輸液影響。公司在 2025 年結束時擁有 9.538 億美元的現金和投資 | [Link](https://longbridge.com/zh-HK/news/272301526.md) | --- > **免責聲明**：本文內容僅供參考，不構成任何投資建議。