Accessibility StatementSkip Navigation NEW YORK, Sept. 24, 2025 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Sarepta Therapeutics, Inc. (NASDAQ: SRPT) breached their fiduciary duties to shareholders. According to a federal securities lawsuit, Insiders at Sarepta Therapeutics caused the company to misrepresent or fail to disclose that (i) ELEVIDYS posed significant safety risks to patients: (ii) ELEVIDYS trial regimes and pro ...

Core Viewpoint - A class action lawsuit has been filed against Sarepta Therapeutics, Inc. for allegedly misleading investors regarding the safety of its gene therapy drug, ELEVIDYS, during the period from June 22, 2023, to June 24, 2025 [1][2]. Allegations - The lawsuit claims that Sarepta failed to disclose significant safety risks associated with ELEVIDYS, including the inability of trial protocols to detect severe side effects and the potential for adverse events to halt recruitment and dosing in clinical trials [2]. - Specific allegations include that the severity of adverse events would attract regulatory scrutiny and increase risks around the therapy's approvals [2]. Stock Price Impact - Following a safety update on March 18, 2025, which reported a patient death after ELEVIDYS treatment, Sarepta's stock price dropped by $27.81, or 27.44%, closing at $73.54 [3]. - On June 15, 2025, after disclosing a second patient death due to acute liver failure and suspending shipments for non-ambulatory patients, the stock fell by $15.24, or 42.12%, closing at $20.91 [3]. - The FDA's investigation announcement on June 24, 2025, regarding acute liver failure risks led to an additional stock price decline of $1.52, or 8.01%, closing at $17.46 [4]. Class Action Participation - Shareholders may be eligible to participate in the class action against Sarepta and must file a motion for lead plaintiff by August 25, 2025, to represent other class members [5].

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 the safety of ELEVIDYS, including significant safety risks and failure to detect severe side effects during clinical trials [2]. - It is alleged that the adverse events from ELEVIDYS treatment could lead to a halt in recruitment and dosing in trials, increased regulatory scrutiny, and greater risks regarding the therapy's approvals [2]. Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until August 25, 2025, to request to be appointed as lead plaintiff in the lawsuit [3]. - Participation in the lawsuit does not require investors to incur 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 has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].

Core Viewpoint - A class action lawsuit has been filed against Sarepta Therapeutics, Inc. for allegedly misleading investors regarding the safety and revenue outlook of its gene therapy ELEVIDYS, which is intended to treat Duchenne muscular dystrophy [1][3]. Company Overview - Sarepta Therapeutics is a biopharmaceutical company focused on developing gene therapies, specifically ELEVIDYS, for treating Duchenne muscular dystrophy [3]. Allegations and Misleading Statements - The lawsuit claims that Sarepta made materially false and misleading statements about ELEVIDYS, leading investors to believe it was a safe therapy with no hindrances to broader application approval [3]. - Specific allegations include: - ELEVIDYS posed significant safety risks to patients [3]. - Trial protocols failed to detect severe side effects [3]. - Adverse events would lead to halted recruitment and dosing in trials, attracting regulatory scrutiny [3]. - Positive statements made by the company lacked a reasonable basis due to undisclosed material adverse facts [3]. Stock Price Impact - Following a safety update on March 18, 2025, where a patient died after treatment with ELEVIDYS, Sarepta's stock price fell by $27.81 per share, or 27.44%, closing at $73.54 [4]. - On April 4, 2025, after the company disclosed regulatory scrutiny and halted recruitment, the stock price fell by $4.18 per share, or 7.13%, closing at $54.43 [4]. - A second patient death was reported on June 15, 2025, leading to a significant drop of $15.24 per share, or 42.12%, closing at $20.91 [4]. - Following an FDA Safety Communication on June 24, 2025, the stock price fell by $1.52 per share, or 8.01%, closing at $17.46 [4].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of Sarepta Therapeutics, Inc. regarding a class action lawsuit alleging that the company made materially false and misleading statements about its gene therapy product, ELEVIDYS, which poses significant safety risks to patients [1]. Group 1: Allegations - The complaint alleges that during the class period from June 22, 2023, to June 24, 2025, Sarepta Therapeutics failed to disclose significant safety risks associated with ELEVIDYS, a prescription gene therapy for Duchenne [1]. - It is claimed that the trial regimes and protocols for ELEVIDYS did not adequately detect severe side effects, leading to potential regulatory scrutiny and halting of recruitment and dosing in trials [1]. - The severity of adverse events from ELEVIDYS treatment is said to have misled investors regarding the therapy's safety and approval prospects [1]. Group 2: Class Action Details - Shareholders who purchased shares of SRPT during the specified class period are encouraged to register for the class action, with a deadline set for August 25, 2025 [2]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the status of the case [2]. - There is no cost or obligation for shareholders to participate in this class action [2]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors affected by deceit and illegal business practices [3]. - The firm aims to ensure that companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [3].

Core Viewpoint - A securities class-action lawsuit has been initiated against Sarepta Therapeutics due to safety concerns and regulatory setbacks related to its gene therapy, ELEVIDYS, alleging that the company misled investors about the treatment's safety and efficacy [1]. Company Developments - The lawsuit claims that Sarepta misrepresented ELEVIDYS as a safe and effective treatment with a clear path to regulatory approval, which has led to significant investor losses [1]. - The European Medicines Agency (EMA) rejected ELEVIDYS on July 24, 2025, after a trial involving 125 children showed no significant improvement in movement compared to a placebo, severely impacting Sarepta's European market expansion plans [3]. - The timeline of disclosures indicates that Sarepta's stock price has faced multiple declines due to safety and regulatory news, including a patient death in an ELEVIDYS trial reported on March 18, 2025, and a subsequent investigation by EU authorities [6]. Legal and Investigative Actions - Hagens Berman, a national shareholder rights firm, is investigating claims on behalf of investors who suffered substantial losses and is encouraging individuals with relevant information to come forward [4][5]. - The firm has set a deadline of August 25, 2025, for investors to be considered as Lead Plaintiff in the lawsuit, which covers the class period from June 22, 2023, to June 24, 2025 [2].

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 and failures in trial protocols to detect severe side effects [2]. - It is alleged that the adverse events from ELEVIDYS treatment would lead to a halt in recruitment and dosing in trials, attract regulatory scrutiny, and increase risks around the therapy's approvals [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 serving as a lead plaintiff [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 securities of Sarepta Therapeutics, Inc. during the specified class period of the upcoming lead plaintiff deadline for a class action lawsuit [1][3]. Group 1: Class Action Details - Investors who purchased Sarepta Therapeutics securities between June 22, 2023, and June 24, 2025, 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][5]. - The lawsuit alleges that Sarepta made false and misleading statements regarding the safety and efficacy of its gene therapy product, ELEVIDYS, which is intended for patients with Duchenne muscular dystrophy [5]. Group 2: Legal Representation - 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 significant settlements for investors [4]. - The firm has been recognized for its achievements, including being ranked No. 1 for securities class action settlements in 2017 and recovering over $438 million for investors in 2019 [4].

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, during a specified class period [1][3]. Company Overview - Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on developing therapies for Duchenne muscular dystrophy, including its gene therapy product, 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 price 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]. Lead Plaintiff 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, representing the interests of the class [8].

Core Viewpoint - A securities class-action lawsuit has been initiated against Sarepta Therapeutics due to safety concerns and regulatory setbacks related to its gene therapy, ELEVIDYS, alleging that the company misled investors about the treatment's safety and efficacy [1]. Group 1: Lawsuit Details - The lawsuit claims that Sarepta misrepresented ELEVIDYS as a safe and effective treatment with a clear path to regulatory approval [1]. - The class period for the lawsuit is from June 22, 2023, to June 24, 2025, with a deadline for investors to serve as Lead Plaintiff set for August 25, 2025 [2]. - Hagens Berman is investigating claims on behalf of investors who suffered substantial losses and is encouraging those with knowledge of the situation to come forward [4]. Group 2: Regulatory Challenges - European regulators have rejected ELEVIDYS, with the European Medicines Agency (EMA) stating that a trial involving 125 children showed no significant improvement in movement for patients receiving the therapy compared to those receiving a placebo [3]. - The EMA's decision significantly impacts Sarepta's plans to expand in the European market and raises concerns about the effectiveness and safety of gene therapies [3]. Group 3: Timeline of Events - Key events leading to the lawsuit include a patient death in an ELEVIDYS trial reported on March 18, 2025, and a second patient death from acute liver failure on June 15, 2025, which led to the suspension of shipments for certain patient groups [6]. - The FDA issued a safety communication on June 24, 2025, confirming its investigation into the risk of acute liver failure associated with ELEVIDYS [6]. Group 4: Investigation and Whistleblower Information - Hagens Berman is actively seeking information from whistleblowers who may have non-public information regarding Sarepta, with potential rewards for original information provided to the SEC [5].