近日，美国食品药品管理局（FDA）调查结果显示，一名八岁男童的死亡事故与Sarepta的基因疗法"无 关"。 （文章来源：华尔街见闻） 罗氏制药将恢复在美国市场之外的基因疗法Elevidys发货工作。 ...

POLAND - 2025/01/25: In this photo illustration, the Sarepta Therapeutics company logo is seen ... More displayed on a smartphone screen. (Photo Illustration by Piotr Swat/SOPA Images/LightRocket via Getty Images) Sarepta's current distressed valuation makes it an attractive acquisition candidate for larger pharmaceutical companies seeking gene therapy capabilities. The company's expertise, intellectual property, and market-leading position in Duchenne treatments could command significant premiums in a take ...

NEW YORK, July 29, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Sarepta Therapeutics, Inc. ("Sarepta" or the "Company") (NASDAQ: SRPT) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Sarepta investors who were adversely affected by alleged securities fraud between June 22, 2023 and June 24, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/sarepta-lawsuit-submissio ...

Company Performance & Regulatory Actions - Shares of Sarepta Therapeutics experienced a pre-market increase of approximately 36% [1] - Sarepta Therapeutics will resume shipping Alvdus, a gene therapy for muscular disorders, to ambulatory patients [1] - The FDA had previously recommended a pause in shipments due to safety concerns following three patient deaths [1] - Sarepta's stock is still down by about 84% this year [1] Safety Concerns & FDA Response - Initial concerns arose regarding deaths in non-ambulatory patients [2] - The FDA's Center for Biologics Evaluation and Research initially advocated for a complete halt to shipments [2] - The FDA later allowed shipments to continue for ambulatory patients due to pushback from patient families [3][4] - A recent patient death was deemed unrelated to the gene therapy by the FDA [1] Industry & Political Context - The Wall Street Journal published an op-ed criticizing the FDA's approach to drug innovation, referring to it as a "surrepta mugging" [5] - Criticism of the FDA's actions extended across the political spectrum [5][6]

Group 1 - Major stock index futures are showing positive movement, with Dow futures up 0.16%, S&P 500 futures up 0.24%, and Nasdaq futures up 0.40% [1] - Technology stocks are mostly rising, with Nvidia up over 1.5% and AMD and Advanced Micro Devices up over 1% [2] - Some Chinese concept stocks are experiencing significant gains, with Li Auto up over 4%, Global Data up over 3%, and Miniso and NIO up over 1% [2] Group 2 - Nvidia reportedly placed an order for 300,000 H20 chips from TSMC, contributing to its pre-market rise of over 1.5% [4] - Sarepta Therapeutics saw a pre-market surge of over 40% after the FDA authorized the resumption of its gene therapy Elevidys for treating Duchenne muscular dystrophy [5] - Apple announced the closure of its first direct store in China, located in Dalian, due to the departure of several retailers from the shopping center, with the store set to close on August 9, 2025 [6] Group 3 - Ford has signed a new $3 billion term loan agreement, which will last until July 28, 2026, with drawn loans maturing on December 31, 2028 [8] - Stellantis reported a 13% year-over-year decline in net revenue for the first half of 2025, totaling €74.3 billion, primarily due to declines in North America and Europe, resulting in a net loss of €2.3 billion compared to a net profit of €5.6 billion in the same period last year [9]

来源：格隆汇APP 格隆汇7月29日丨生物技术公司Sarepta Therapeutics盘前暴涨超45%，公司获FDA批准恢复基因疗法 Elevidys用于杜氏肌营养不良症(DMD)治疗。 ...

Core Viewpoint - Class actions have been initiated on behalf of stockholders of Hims & Hers Health, Inc. and Sarepta Therapeutics, Inc. due to alleged misleading statements and undisclosed material facts regarding their business operations and prospects [1][4]. Hims & Hers Health, Inc. (NYSE: HIMS) - Class period is from April 29, 2025, to June 23, 2025, with a lead plaintiff deadline of August 25, 2025 [2]. - Allegations include that Hims engaged in deceptive promotion of illegitimate versions of Wegovy, risking patient safety and jeopardizing collaboration with Novo Nordisk [2][3]. - Defendants are accused of making false statements about the partnership with Novo, which was supposed to ensure access to Wegovy for Hims subscribers, and misrepresenting the offerings of compounded semaglutide products [3]. Sarepta Therapeutics, Inc. (NASDAQ: SRPT) - Class period is from June 22, 2023, to June 24, 2025, with a lead plaintiff deadline of August 25, 2025 [4]. - The complaint alleges that Sarepta misled investors about the safety and revenue outlook of its gene therapy ELEVIDYS, which is intended for treating Duchenne muscular dystrophy [4]. - Specific allegations include failure to disclose significant safety risks associated with ELEVIDYS, misleading statements about trial protocols, and the potential for regulatory scrutiny due to adverse events [4]. - Following a safety update on March 18, 2025, where a patient died after treatment, Sarepta's stock price fell by $27.81 per share, or 27.44% [5]. - Subsequent disclosures of additional patient deaths led to further declines in stock price, including a drop of $15.24 per share, or 42.12%, on June 15, 2025 [6].

Core Viewpoint - The article discusses a class action lawsuit against Sarepta Therapeutics, alleging violations of the Securities Exchange Act of 1934 due to misleading statements regarding the safety and efficacy of its gene therapy, ELEVIDYS, for Duchenne muscular dystrophy [1][3]. Company Overview - Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on developing therapies for Duchenne muscular dystrophy, including the gene therapy ELEVIDYS [2]. Allegations of the Lawsuit - The lawsuit claims that Sarepta and its executives made false or misleading statements about ELEVIDYS, including significant safety risks, inadequate trial protocols to detect severe side effects, and the potential for halting recruitment and dosing due to adverse events [3]. - Specific incidents cited include: - On March 18, 2025, a patient treated with ELEVIDYS suffered acute liver failure leading to death, causing Sarepta's stock to drop over 27% [4]. - On April 4, 2025, Sarepta disclosed that EU authorities requested a review of the death, leading to a further stock decline of over 7% [5]. - On June 15, 2025, a second patient died from acute liver failure, prompting Sarepta to suspend shipments and pause dosing, resulting in a stock drop of over 42% [6]. - On June 24, 2025, the FDA announced an investigation into the risk of acute liver failure associated with ELEVIDYS, causing an additional stock decline of over 8% [7]. Legal Process - The Private Securities Litigation Reform Act of 1995 allows investors who purchased Sarepta securities during the class period to seek appointment as lead plaintiff in the lawsuit, representing the interests of all class members [8].

In a major win for Sarepta, US regulators are recommending that patients who can walk be allowed to take its gene therapy Elevidys again https://t.co/lnGkzEsubE ...

美国食品药品管理局（FDA）：调查结果显示，八岁男孩的死亡与Sarepta Therapeutics的基因疗法 Elevidys无关。 ...