Sarepta shares drop 14% in premarket trading after its gene therapy fails to get EU regulator approval https://t.co/4inyYyirFu ...

NEW YORK, July 24, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Sarepta Therapeutics, Inc. (NASDAQ: SRPT). Shareholders who purchased shares of SRPT during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/sarepta-loss-submission-form/?id=157777&from=3 CLASS PERIOD: June 22, 2 ...

NEW YORK, July 24, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Sarepta Therapeutics, Inc. (NASDAQ: SRPT).Shareholders who purchased shares of SRPT during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/sarepta-loss-submission-form/?id=157768&from=4CLASS PERIOD: June 22, 2023 to J ...

NEW YORK, July 24, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Sarepta Therapeutics, Inc. (NASDAQ: SRPT) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Sarepta, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/sarepta-therapeutics-inc-class-action. Investors have until August 25, 2025, to as ...

Core Viewpoint - Sarepta Therapeutics, Inc. experienced a significant decline in share price following the report of a third patient death related to its experimental gene therapy, ELEVIDYS, leading to a 36% drop in stock value on July 18, 2025 [1]. Legal Developments - A securities class action lawsuit has been filed against Sarepta, representing investors who acquired securities between June 22, 2023, and June 24, 2025 [2]. - The lawsuit focuses on Sarepta's disclosures regarding the safety and efficacy of ELEVIDYS, alleging that the company misled investors about the therapy's safety and potential for broader application [4]. Safety Concerns - The complaint highlights that Sarepta failed to disclose critical information regarding the safety of ELEVIDYS, with the first indication of issues arising on March 18, 2025, when a patient death was reported [5]. - Subsequent disclosures included a second patient death on June 15, 2025, and a safety communication from the FDA on June 24, 2025, which investigated the risk of acute liver failure associated with ELEVIDYS [7][8]. Regulatory Actions - Following the reported deaths, the FDA placed Sarepta's clinical trials for both ELEVIDYS and another investigational gene therapy, SRP-9004, on clinical hold [10]. - The company faced increased regulatory scrutiny and was compelled to halt patient recruitment and dosing in its clinical studies due to the severity of adverse events [8]. Financial Impact - The financial press reported a drastic reduction in Sarepta's price target to $0 by H.C. Wainwright following the adverse developments [10].

Core Viewpoint - A class action securities lawsuit has been filed against Sarepta Therapeutics, Inc. due to alleged securities fraud affecting investors between June 22, 2023, and June 24, 2025 [1] Group 1: Lawsuit Details - The lawsuit claims that Sarepta made false statements regarding the safety of its gene therapy ELEVIDYS for Duchenne, which posed significant risks to patients [2] - It is alleged that the trial protocols for ELEVIDYS failed to identify severe side effects, leading to potential regulatory scrutiny and risks regarding the therapy's approvals [2] - The complaint asserts that the defendants misled investors with positive statements that lacked a reasonable basis due to the severity of adverse events from ELEVIDYS treatment [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, with no obligation to participate [3] Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has extensive expertise in complex securities litigation [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the U.S. [4]

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There were warnings to the FDA about Sarepta before US regulators asked the company to halt shipments of its gene therapy https://t.co/ZZC0xgoUpS ...

Core Insights - Sarepta Therapeutics (SRPT) is experiencing a decline in share price following the announcement of a voluntary and temporary halt to all U.S. shipments of its gene therapy Elevidys, which is designed for Duchenne muscular dystrophy (DMD) [1][3] Company Developments - The pause in shipments is a proactive measure to address information requests and complete the safety labeling supplement process with the FDA, indicating the company's commitment to a science-based review [2][8] - Elevidys has been a significant revenue driver for Sarepta, contributing over half of the company's total revenues in Q1 2025, and the halt is expected to have a substantial negative impact on financial performance in the latter half of the year [3][8] - The decision to halt shipments follows the death of a patient in a clinical trial, marking the third patient death linked to Sarepta's gene therapies, which raises serious safety concerns [4][5][6] Regulatory Actions - The FDA has placed all of Sarepta's clinical studies for limb-girdle muscular dystrophy (LGMD) on hold due to the patient deaths associated with acute liver failure (ALF) [6][7] - The agency requested the voluntary stop of Elevidys shipments, which Sarepta initially resisted but ultimately complied with [7][8] Financial Restructuring - In response to the challenges, Sarepta announced a major restructuring plan that includes cutting 36% of its workforce, approximately 500 employees, to achieve annual savings of $120 million, alongside a reprioritization of its pipeline to save an additional $300 million per year [12][14] - The company is now focusing on its siRNA pipeline, which was acquired through a recent deal with Arrowhead Pharmaceuticals, targeting various conditions and expecting initial clinical data by year-end [14] Market Performance - Year-to-date, Sarepta's shares have plummeted by 89%, contrasting sharply with the industry's modest decline of 2.2% [7]

Core Viewpoint - A lawsuit has been filed against Sarepta Therapeutics, Inc. and certain senior executives for potential violations of federal securities laws, particularly concerning the safety claims of their product Elevidys [1][2]. Company Overview - Sarepta Therapeutics is a biopharmaceutical company focused on developing treatments for rare diseases, with Elevidys being its most significant product aimed at treating Duchenne muscular dystrophy [3]. Allegations and Impact - The lawsuit alleges that Sarepta misrepresented the safety profile of Elevidys, claiming that the benefits outweighed the risks, while in reality, the treatment has been linked to fatal acute liver failure in some patients [3]. - Following the announcement of patient deaths related to Elevidys, Sarepta's stock experienced significant declines, with a drop of over 27% on March 18, 2025, and a further decline of more than 42% on June 16, 2025 [4][5]. Legal Proceedings - The case is pending in the U.S. District Court for the Southern District of New York, with investors having until August 25, 2025, to seek appointment as lead plaintiffs [2].