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]

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 ...