智通财经APP获悉，周一美股盘前，多家生物科技公司股价出现下跌。此前有报道称，曾被解职的美国 食品药品监督管理局(FDA)疫苗监管官员Vinay Prasad将重返该机构。 作为肿瘤学家出身的Prasad，还曾多次公开质疑美国新冠疫苗和口罩强制令。今年5月，FDA局长Marty Makary任命其担任该中心主任。在其任期内，因叫停Sarepta Therapeutics基因疗法供货的决定，FDA对 杜氏肌营养不良症治疗方案的审查力度显著加强。 此外，Prasad因推翻FDA工作人员意见，限制Moderna(MRNA.US)和诺瓦瓦克斯医药(NVAX.US)新冠疫 苗使用范围而引发公共卫生专家的强烈不满。 尽管Prasad确定将重新领导FDA生物制品评价与研究中心，但其是否会同时恢复此前担任的首席科学官 和首席医疗官职务仍存悬念。 截至发稿，Capricor Therapeutics(CAPR.US)下跌近8%，Sarepta Therapeutics(SRPT.US)下挫超4%， Replimune(REPL.US)跌幅近7%。 据了解，这位颇具争议的官员曾因下令暂停Sarepta Therapeutics杜 ...

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Sarepta Therapeutics, Inc. securities between June 22, 2023, and June 24, 2025, of the upcoming lead plaintiff deadline on August 25, 2025, for a class action lawsuit [1]. Group 1: Class Action Details - Investors who purchased Sarepta securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and those wishing to serve as lead plaintiff must act by August 25, 2025 [3]. - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [6]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting their own achievements in this area [4]. - The firm has secured significant settlements for investors, including over $438 million in 2019 alone, and has been consistently ranked among the top firms for securities class action settlements [4]. Group 3: Case Allegations - The lawsuit alleges that Sarepta made false and misleading statements regarding its gene therapy ELEVIDYS, which posed significant safety risks and failed to detect severe side effects during trials [5]. - It is claimed that the adverse events from ELEVIDYS treatment led to a halt in recruitment and dosing in trials, attracting regulatory scrutiny and increasing risks around the therapy's approvals [5]. - The lawsuit asserts that investors suffered damages when the true details about the therapy were revealed [5].

Core Viewpoint - A lawsuit has been filed against Sarepta Therapeutics, Inc. and its senior executives for potential violations of federal securities laws, particularly concerning the safety claims of its product Elevidys [1][2]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, titled Dolgicer v. Sarepta Therapeutics, Inc., et al., No. 25-cv-05317 [2]. - Investors have until August 25, 2025, to request to be appointed to lead the case [2]. Group 2: Product and Allegations - Sarepta is focused on developing treatments for rare diseases, with Elevidys being its key product for Duchenne muscular dystrophy [3]. - The complaint alleges that Sarepta misrepresented the safety profile of Elevidys, claiming its benefits outweighed risks, while in reality, it has caused fatal acute liver failure in some patients [3]. Group 3: Stock Performance and Impact - Following the announcement of a patient's death due to Elevidys on March 18, 2025, Sarepta's stock plummeted by $27.81, or over 27%, from $101.35 to $73.54 per share [4]. - A second death announcement on June 15, 2025, led to a further decline of $15.24, or more than 42%, from $36.18 to $20.94 per share [4]. - A third death related to Elevidys was reported on July 17, 2025, resulting in a stock drop of over 40% on July 18, 2025 [5].

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 product, 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 adverse events to halt clinical trials and regulatory approvals [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 - Investors who purchased Sarepta securities during the class period can seek appointment as lead plaintiff in the lawsuit, representing the interests of all class members [8].

Core Viewpoint - A class action securities lawsuit has been filed against Sarepta Therapeutics, Inc. alleging securities fraud related to the company's gene therapy product, ELEVIDYS, which is intended for treating Duchenne muscular dystrophy [1][2]. Group 1: Lawsuit Details - The lawsuit seeks to recover losses for Sarepta investors affected by alleged securities fraud between June 22, 2023, and June 24, 2025 [1]. - The complaint claims that Sarepta made false statements regarding ELEVIDYS, including significant safety risks, failure to detect severe side effects in trials, and potential regulatory scrutiny due to adverse events [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until August 25, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing hundreds of millions of dollars for shareholders and is recognized as one of the top securities litigation firms in the United States [4].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Sarepta Therapeutics, Inc. securities between June 22, 2023, and June 24, 2025, of the upcoming lead plaintiff deadline on August 25, 2025 [1] Group 1: Class Action Details - Investors who purchased Sarepta Therapeutics securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by August 25, 2025 [3] - The lawsuit alleges that Sarepta made false and misleading statements regarding the safety and efficacy of its gene therapy, ELEVIDYS, which led to significant risks and potential damages for investors [5] Group 2: Rosen Law Firm's Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in recovering hundreds of millions for investors [4] - The firm achieved the largest securities class action settlement against a Chinese company at the time and has been consistently ranked among the top firms for securities class action settlements since 2013 [4]

Core Viewpoint - The complaint against Sarepta Therapeutics alleges violations of federal securities laws due to misleading statements regarding the safety and efficacy of its treatment ELEVIDYS, which has been linked to patient deaths and regulatory scrutiny [2]. Group 1: Safety Concerns and Regulatory Actions - ELEVIDYS is reported to pose significant safety risks, with trial protocols failing to detect severe side effects [2] - Following a patient death on March 18, 2025, Sarepta's stock price dropped by $27.81, or 27.44%, closing at $73.54 [3] - On April 4, 2025, Sarepta halted recruitment and dosing in some clinical studies after EU authorities requested a review of the death, leading to a further stock price decline of $4.18, or 7.13%, to $54.43 [4] - A second patient death due to acute liver failure was disclosed on June 15, 2025, prompting Sarepta to suspend shipments for non-ambulatory patients and pause dosing in one study [5] - Following the second death, Sarepta's stock fell by $15.24, or 42.12%, closing at $20.91 [6] - The FDA issued a Safety Communication on June 24, 2025, regarding the investigation into the deaths and acute liver failure risks associated with ELEVIDYS, resulting in a stock price drop of $1.52, or 8.01%, to $17.46 [6][7] Group 2: Legal Proceedings and Class Action - The lead plaintiff in the class action is the investor with the largest financial interest, who will oversee the litigation on behalf of the class [8] - Members of the putative class can choose to serve as lead plaintiff or remain absent without affecting their ability to share in any recovery [8] - Faruqi & Faruqi, LLP encourages individuals with information regarding Sarepta's conduct to come forward, including whistleblowers and former employees [9]

NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) between June 22, 2023 and June 24, 2025, both dates inclusive (the "Class Period"), of the important August 25, 2025 lead plaintiff deadline. Contact Information: Laurence Rosen, Esq. Phillip Kim, Esq. The Rosen Law Firm, P.A. 275 Madison Avenue, 40th Floor New York, NY 10016 Tel: (212) 686-1060 SO WHAT: If you purchased Sarepta sec ...

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Sarepta Therapeutics, Inc. regarding a class action lawsuit related to misleading statements about the safety and efficacy of its gene therapy product, ELEVIDYS [1][3]. Group 1: Allegations and Class Period - The class period for the lawsuit is from June 22, 2023, to June 24, 2025 [3]. - Allegations include that Sarepta Therapeutics made materially false and misleading statements about ELEVIDYS, which is a prescription gene therapy for Duchenne muscular dystrophy [3]. - Specific claims include that ELEVIDYS posed significant safety risks, trial protocols failed to detect severe side effects, and adverse events would lead to halted recruitment and increased regulatory scrutiny [3]. Group 2: Next Steps for Shareholders - Shareholders are encouraged to register for the class action by August 25, 2025, to participate in potential recovery [4]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the case [4]. - There is no cost or obligation for shareholders to participate in the case [4]. Group 3: Law Firm's Mission - The Gross Law Firm aims to protect investors' rights who have suffered due to deceit and illegal business practices [5]. - The firm is committed to ensuring companies adhere to responsible business practices and seeks recovery for investors affected by misleading statements [5].

Core Insights - Sarepta Therapeutics, Inc. (SRPT) reported a second-quarter 2025 adjusted EPS of $2.02, significantly exceeding the Zacks Consensus Estimate of $1.11, primarily due to higher collaboration revenues and lower operating expenses [1][9] - Total revenues reached $611.1 million, marking a 68% year-over-year increase, driven by sales of Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD), which also surpassed the Zacks Consensus Estimate of $529.5 million [2][9] Financial Performance - Adjusted EPS of $2.02 compared to 43 cents in the same quarter last year, while including depreciation and amortization, the EPS was $1.89 compared to 7 cents previously [1][2] - Product revenues increased by 42% year over year to $513.1 million, with Elevidys sales contributing significantly [3][4] - Elevidys sales alone generated $281.9 million, a 132% increase year over year, exceeding estimates [4][5] Collaboration and Revenue Streams - Collaboration revenues associated with Elevidys amounted to approximately $98.0 million, including a $63.5 million milestone payment from Roche for Elevidys approval in Japan [5][6] - The licensing agreement with Roche grants exclusive rights to market Elevidys in non-U.S. markets [6] Operating Costs - Adjusted R&D expenses totaled $181.7 million, an 18% increase year over year, reflecting higher clinical material expenses for Elevidys [7] - Adjusted SG&A expenses rose 7% to $113.4 million, driven by increased professional service expenses related to Elevidys marketing efforts [7] Future Guidance - The company expects to generate around $900 million from its three PMO therapies in 2025 [12] - Management anticipates minimum annual revenues of $500 million from Elevidys infusions in the ambulant population for the full year [11] Pipeline and Restructuring - Sarepta is addressing safety concerns related to patient deaths linked to its gene therapies and is developing a new protocol for safer administration in non-ambulatory patients [13][18] - A restructuring plan aims to save nearly $400 million annually starting in 2026, including a workforce reduction of 36% [19][20] - The company has shifted focus to siRNA programs acquired from Arrowhead Pharmaceuticals, pausing most of its LGMD pipeline development [20][21]