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][3]. 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]. Legal Proceedings - The lawsuit is pending in the U.S. District Court for the Southern District of New York, with claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Sarepta securities [2]. Product Safety Concerns - Elevidys has been alleged to cause fatal acute liver failure in some patients, contradicting Sarepta's claims about the treatment's safety profile [3]. Stock Performance - Following the announcement of a patient's death due to acute liver failure on March 18, 2025, Sarepta's stock price fell by $27.81, or over 27%, from $101.35 to $73.54 per share [4]. - A second patient 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 patient death related to Elevidys was reported on July 17, 2025, resulting in a stock price drop of over 40% on July 18, 2025 [5].

Sarepta Therapeutics’ shares soared after the US biotech reported revenue that beat estimates, which analysts attributed in part to a milestone payment for its controversial gene therapy Elevidys https://t.co/7DUXqOz5Vq ...

Sarepta Therapeutics (SRPT) came out with quarterly earnings of $2.02 per share, beating the Zacks Consensus Estimate of $1.11 per share. This compares to earnings of $0.07 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +81.98%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.35 per share when it actually produced a loss of $3.42, delivering a surprise of -1077.14%.Over the last fo ...

Core Viewpoint - The European Medicines Agency (EMA) recommended the refusal of marketing authorization for Sarepta's ELEVIDYS, leading to a significant decline in the company's stock price [1][2]. Group 1: Regulatory and Clinical Developments - The EMA concluded that ELEVIDYS lacked efficacy, as a key study involving 125 children showed no significant improvement in movement abilities compared to a placebo group [4]. - The EMA's recommendation follows a series of negative events for Sarepta, including patient deaths and a black box warning for acute liver injury and failure on the ELEVIDYS label [2][4]. Group 2: Legal and Financial Implications - A securities class action lawsuit has been filed against Sarepta, alleging that the company made misleading statements regarding the safety and efficacy of ELEVIDYS, which misled investors about its regulatory prospects [5][6]. - The lawsuit claims that Sarepta failed to disclose significant safety risks associated with ELEVIDYS and inadequacies in clinical trial protocols [6]. - The timeline of disclosures includes patient deaths and safety updates that triggered sharp declines in Sarepta's stock price, with the FDA confirming an investigation into acute liver failure risks associated with the drug [7][8][9]. Group 3: Investor Actions and Investigations - Hagens Berman, a national shareholders rights firm, is investigating the legal claims and encourages affected investors to submit their losses [3][11]. - The firm is also seeking information from individuals who may assist in the investigation regarding Sarepta's disclosures and the efficacy of ELEVIDYS [11].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-14895 SAREPTA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 93-0797222 (State or other juris ...

NEW YORK, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Sarepta Therapeutics, Inc. ("Sarepta" or the "Company") (NASDAQ:SRPT) in the United States District Court for the Southern District of New York on behalf of all persons and entities who purchased or otherwise acquired Sarepta securities between June 22,2023 and June 24, 2025, both dates inclusive (the "Class Period"). Inves ...

Core Viewpoint - A class action lawsuit has been filed against Sarepta Therapeutics, alleging that the company made false or misleading statements regarding its gene therapy product ELEVIDYS, which is intended for treating Duchenne muscular dystrophy [3][4]. Group 1: Company Overview - Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on developing treatments for Duchenne muscular dystrophy, including the gene therapy product ELEVIDYS [3]. Group 2: Allegations and Impact - The lawsuit claims that during the class period, Sarepta failed to disclose significant safety risks associated with ELEVIDYS, inadequacies in clinical trial protocols, and the potential for adverse events that could jeopardize regulatory approvals [3]. - On March 18, 2025, Sarepta disclosed a patient death due to acute liver failure linked to ELEVIDYS, resulting in a stock price drop of over 27% [4]. - Following an April 4, 2025 announcement regarding a review by European regulatory authorities, Sarepta's stock fell an additional 7% after halting recruitment and dosing in certain clinical trials [5]. - A second patient death was reported on June 15, 2025, leading to a 42% decline in stock price as the company suspended shipments of ELEVIDYS for non-ambulatory patients [6]. - The FDA issued a Safety Communication on June 24, 2025, confirming investigations into the deaths, causing an additional 8% drop in Sarepta's stock [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 Claims - 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]. Stock Performance and Market Reaction - Following the announcement of a patient's death due to acute liver failure on March 18, 2025, Sarepta's stock price dropped by $27.81, or over 27%, from $101.35 to $73.54 per share [4]. - After a second patient death was reported on June 15, 2025, the stock fell by $15.24, or more than 42%, from $36.18 to $20.94 per share [4]. - A third patient death was disclosed on July 17, 2025, leading to another significant decline in stock price of over 40% on July 18, 2025 [5].

Core Viewpoint - Sarepta Therapeutics is expected to report second-quarter 2025 earnings on August 6, with significant increases in sales and earnings per share compared to the previous year, despite recent challenges related to safety issues with its gene therapy products [1][11]. Financial Performance - The Zacks Consensus Estimate for total sales is approximately $530 million and earnings per share (EPS) is $1.11, indicating a substantial increase from the prior year [1][11]. - Preliminary net product revenues for the second quarter are reported at $513 million, including $282 million from Elevidys sales [3][11]. - Adjusted R&D and SG&A expenses for the quarter are estimated to be around $294 million [3]. Product Portfolio and Market Challenges - Sarepta has four marketed products targeting Duchenne muscular dystrophy (DMD), including the gene therapy Elevidys and three PMO therapies [2]. - Recent safety concerns have arisen due to three patient deaths linked to its gene therapy treatments, leading to a temporary market withdrawal of Elevidys [4][5]. - The FDA has recently cleared Elevidys for use in ambulatory patients, allowing Sarepta to resume shipments [6]. Strategic Initiatives - To address safety issues, the company is developing a new protocol for Elevidys administration in non-ambulatory patients and plans to submit these findings to the FDA [7]. - A restructuring plan has been initiated to save nearly $400 million annually starting in 2026, which includes laying off 36% of its workforce, approximately 500 employees [8]. - Sarepta aims to generate around $300 million in annual savings by reprioritizing its pipeline, focusing on siRNA programs acquired from Arrowhead Pharmaceuticals [9]. Earnings Surprise History - The company's performance has been mixed, with earnings missing estimates in two of the last four quarters, resulting in a negative average surprise of 194.53% [12]. - The stock has underperformed the industry so far this year [12]. Earnings Prediction - Currently, Sarepta has an Earnings ESP of 0.00% and a Zacks Rank of 4 (Sell), indicating a low likelihood of an earnings beat [14].

Core Points - 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 company's gene therapy product, ELEVIDYS [1] - The class period for the lawsuit is from June 22, 2023, to June 24, 2025, during which significant safety risks and adverse events associated with ELEVIDYS were allegedly not disclosed [1] - Shareholders are encouraged to register for participation in the class action by the deadline of August 25, 2025, to potentially be appointed as lead plaintiffs [1] Allegations - The complaint alleges that Sarepta Therapeutics made materially false and misleading statements about ELEVIDYS, including the failure to disclose safety risks and inadequate trial protocols [1] - It is claimed that the severity of adverse events from ELEVIDYS treatment could lead to the halting of trials and increased regulatory scrutiny, impacting the therapy's approval status [1] - The allegations suggest that the defendants lacked a reasonable basis for their positive statements regarding the therapy [1] Next Steps for Shareholders - Shareholders who purchased shares during the specified class period are advised to register for the class action, which includes enrollment in a portfolio monitoring system for case updates [1] - There is no cost or obligation for shareholders to participate in the case [1]