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, intended for treating Duchenne muscular dystrophy [1][3]. Company Overview - Sarepta Therapeutics is a biopharmaceutical company focused on developing gene therapies, specifically ELEVIDYS, for Duchenne muscular dystrophy [3]. Allegations - 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 from ELEVIDYS treatment led to a halt in recruitment and dosing, attracting regulatory scrutiny [3]. - Positive statements made by Sarepta 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 (27.44%) to close at $73.54 [4]. - On April 4, 2025, after the company disclosed regulatory requests for a review of the death, the stock price dropped by $4.18 (7.13%) to close at $54.43 [4]. - A second patient death reported on June 15, 2025, led to a further decline of $15.24 (42.12%) in stock price, closing at $20.91 [4]. - Following an FDA Safety Communication on June 24, 2025, regarding the investigation of acute liver failure risks, the stock fell by $1.52 (8.01%) to close at $17.46 [4].

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]

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]. Group 1: Class Action Details - Investors who purchased Sarepta 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]. - 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 achievements in recovering hundreds of millions of dollars for investors [4]. - The firm has been recognized for its performance in securities class action settlements, ranking No. 1 in 2017 and consistently in the top 4 since 2013 [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].

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 after receiving Elevidys, Sarepta's stock price dropped by $27.81, or over 27%, from $101.35 on March 17, 2025, to $73.54 on March 18, 2025 [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 on June 13, 2025, to $20.94 on June 16, 2025 [4]. - A third patient death related to Elevidys was disclosed on July 17, 2025, leading to a further decline of over 40% in the stock price on July 18, 2025 [5]. Legal Proceedings - The lawsuit is pending in the U.S. District Court for the Southern District of New York, with investors having until August 25, 2025, to seek lead plaintiff status [2].

Group 1: Sarepta Therapeutics, Inc. (NASDAQ:SRPT) - The class period for Sarepta is from June 22, 2023, to June 24, 2025, with a lead plaintiff deadline of August 25, 2025 [2] - The lawsuit alleges that Sarepta made materially false and misleading statements regarding its gene therapy ELEVIDYS, which was intended to treat Duchenne muscular dystrophy, leading investors to believe it was safe and had a positive revenue outlook [2] - Significant safety risks associated with ELEVIDYS were not disclosed, including severe side effects that led to the halting of trials and regulatory scrutiny [2][3] - Following the announcement of a patient death related to ELEVIDYS, Sarepta's stock price fell by $27.81 (27.44%) to close at $73.54 on March 18, 2025 [3] - Subsequent disclosures of additional patient deaths and regulatory investigations resulted in further stock price declines, with a notable drop of $15.24 (42.12%) to close at $20.91 on June 15, 2025 [3] Group 2: Petco Health and Wellness Company, Inc. (NASDAQ:WOOF) - The class period for Petco is from January 14, 2021, to June 5, 2025, with a lead plaintiff deadline of August 29, 2025 [4] - The lawsuit claims that Petco made materially false and misleading statements about its business operations, particularly regarding the sustainability of pandemic-related growth and the viability of its premium pet food business model [4][5] - Defendants allegedly overstated Petco's ability to achieve sustainable, profitable growth, with a specific reference to a share price of $95.85 on May 21, 2025 [5]

Core Insights - Sarepta Therapeutics announced a major restructuring involving a 36% workforce reduction, equating to 500 employees, aimed at saving approximately $400 million annually [1] - The FDA has mandated a black box warning for Sarepta's gene therapy drug, ELEVIDYS, due to risks of acute liver injury and acute liver failure [1] Legal Issues - A securities class action lawsuit has been filed against Sarepta, representing investors who acquired securities between June 22, 2023, and June 24, 2025 [2][4] - The lawsuit alleges that Sarepta misled investors regarding the safety and efficacy of ELEVIDYS, claiming the company portrayed the drug as safe while withholding critical risk information [4][5] Safety Concerns - The lawsuit highlights that Sarepta failed to disclose significant safety risks associated with ELEVIDYS and inadequacies in clinical trial protocols [5] - A timeline of events indicates that Sarepta reported a patient death during a trial on March 18, 2025, followed by further disclosures of deaths and regulatory scrutiny [6][7][8] Regulatory Scrutiny - On July 25, 2025, the European Medicines Agency rejected ELEVIDYS due to questions about its effectiveness, leading to a further decline in Sarepta's stock price [9]

Core Points - A class action securities lawsuit has been filed against Sarepta Therapeutics, Inc. for alleged securities fraud affecting investors between June 22, 2023, and June 24, 2025 [1] - The lawsuit claims that Sarepta misled investors regarding the safety and efficacy of its gene therapy product, ELEVIDYS, for Duchenne muscular dystrophy [2] Group 1 - The lawsuit seeks to recover losses for Sarepta investors who were adversely affected by the alleged fraud [1] - The complaint alleges that ELEVIDYS posed significant safety risks, and that trial protocols failed to detect severe side effects [2] - It is claimed that the severity of adverse events would lead to a halt in recruitment and dosing in ELEVIDYS trials, attracting regulatory scrutiny [2] Group 2 - Investors who suffered losses during the relevant time frame have until August 25, 2025, to request to be appointed as lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] - The firm Levi & Korsinsky has a strong track record in securities litigation, having secured hundreds of millions for shareholders [4]