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 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 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 (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, caused the stock to plummet by $15.24 (42.12%) to close 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].

NEW YORK, Aug. 15, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Sarepta Therapeutics, Inc. ("Sarepta" or the "Company") (NASDAQ: SRPT) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Sarepta investors who were adversely affected by alleged securities fraud between June 22, 2023 and June 24, 2025. Follow the link below to get more information and be contacted by a member of our team:https://zlk.com/pslra-1/sarepta-lawsuit-submission- ...

Core Viewpoint - A lawsuit has been filed against Sarepta Therapeutics, Inc. and its senior executives for potential violations of federal securities laws, particularly concerning the safety claims of its product Elevidys [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, captioned Dolgicer v. Sarepta Therapeutics, Inc., et al., No. 25-cv-05317 [2]. - Investors have until August 25, 2025, to request to be appointed to lead the case [2]. Group 2: Product and Allegations - Sarepta is focused on developing treatments for rare diseases, with Elevidys being its primary product for Duchenne muscular dystrophy [3]. - Allegations state that Sarepta misrepresented the safety profile of Elevidys, claiming its benefits outweighed risks, while in reality, it has caused fatal acute liver failure in some patients [3]. Group 3: Stock Performance - Following the announcement of a patient's death due to acute liver failure on March 18, 2025, Sarepta's stock fell by $27.81, or over 27%, from $101.35 to $73.54 [4]. - After a second patient death was reported on June 15, 2025, the stock dropped by $15.24, or more than 42%, from $36.18 to $20.94 [4]. - A third patient death related to Elevidys was disclosed on July 17, 2025, leading to a further decline of over 40% in stock price on July 18, 2025 [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 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 could lead to halted recruitment and dosing in trials, increased regulatory scrutiny, and greater risks for 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 this [3]. - Class members may be entitled to compensation without any out-of-pocket costs or fees [3]. Group 3: Firm Background - Levi & Korsinsky 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]. - The firm has over 70 employees dedicated to serving clients in complex securities litigation [4].

Core Viewpoint - Sarepta Therapeutics is facing a class action lawsuit due to alleged misleading statements and undisclosed safety risks related to its gene therapy product ELEVIDYS, which has resulted in significant stock price declines following patient deaths and regulatory scrutiny [3][4][5][6][7]. 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 Legal Actions - The class action lawsuit claims that Sarepta made false or misleading statements regarding ELEVIDYS, including significant safety risks and inadequate clinical trial protocols [3]. - The lawsuit highlights that the occurrence of severe adverse events led to a pause in recruitment and dosing in trials, raising regulatory concerns and jeopardizing future approvals [3]. Group 3: Stock Price Impact - Following the disclosure of a patient death from acute liver failure on March 18, 2025, Sarepta's stock dropped more than 27% [4]. - An announcement on April 4, 2025, regarding a review by European regulatory authorities led to an additional 7% decline in stock price [5]. - A second patient death reported on June 15, 2025, caused the stock price to decline over 42% [6]. - The FDA's Safety Communication on June 24, 2025, regarding the investigation of patient deaths resulted in an additional 8% drop in stock price [7].

Core Insights - Sarepta Therapeutics (SRPT) has sold at least $174 million worth of its equity investment in Arrowhead Pharmaceuticals to fund a $100 million milestone payment related to the phase I/II study of SRP-1003 for treating myotonic dystrophy type 1 (DM1) [1][4][5] - Following the announcement, Sarepta's shares rose approximately 9%, although the stock has declined 83.2% year-to-date compared to a 2% decline in the industry [1][4] Company Developments - Sarepta entered an exclusive global licensing and collaboration agreement with Arrowhead Pharmaceuticals in February 2025, acquiring rights to four investigational RNA interference therapeutics [3] - The decision to sell equity in Arrowhead was driven by a milestone payment obligation due to the successful early enrollment and safety review of SRP-1003 [4][6] - Sarepta has sold 9.26 million shares of Arrowhead in a private sale and expects to receive at least $174 million in cash proceeds [5] Financial and Operational Challenges - The company is facing scrutiny from investors due to three patient deaths linked to its gene therapy treatments, which were attributed to acute liver failure [6][7] - Following these incidents, Sarepta suspended dosing of Elevidys for non-ambulatory patients but has since resumed shipments after FDA clearance for ambulatory patients [8][9] - To address safety concerns, Sarepta is developing a new protocol for Elevidys administration in non-ambulatory patients and plans to submit findings to the FDA [9] Strategic Restructuring - Last month, Sarepta initiated a restructuring plan aimed at saving nearly $400 million annually starting in 2026, which includes laying off 36% of its workforce [10] - The company is now focusing on its siRNA pipeline acquired from Arrowhead Pharmaceuticals as part of its strategic shift [10]

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]. Allegations - The complaint alleges that during the class period from June 22, 2023, to June 24, 2025, Sarepta Therapeutics made materially false and misleading statements regarding ELEVIDYS, which is a prescription gene therapy for Duchenne muscular dystrophy [1]. - Specific allegations include that ELEVIDYS posed significant safety risks to patients, trial protocols failed to detect severe side effects, and the severity of adverse events would lead to a halt in recruitment and dosing in trials, attracting regulatory scrutiny [1]. 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 of August 25, 2025, to seek lead plaintiff status [2]. - Participants will be enrolled in a portfolio monitoring software to receive updates throughout the lifecycle of the case, with no cost or obligation to participate [2]. Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors who have suffered due to deceit and illegal business practices [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors affected by misleading statements that artificially inflated stock prices [3].

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]. Summary by Sections Class Action Details - 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 gene therapy for Duchenne muscular dystrophy [3]. Specific Allegations - The complaint claims that: - ELEVIDYS posed significant safety risks to patients [3]. - Trial regimes and protocols failed to detect severe side effects [3]. - Adverse events from ELEVIDYS treatment would lead to halting recruitment and dosing in trials, attracting regulatory scrutiny [3]. - The misleading statements resulted in a lack of reasonable basis for positive claims about the therapy [3]. Shareholder Actions - Shareholders are encouraged to register for the class action by August 25, 2025, to potentially become lead plaintiffs [4]. - Registration allows shareholders to receive updates on the case through portfolio monitoring software [4]. Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm focused on protecting investors' rights against deceit and fraud [5].

Core Viewpoint - A lawsuit has been filed against Sarepta Therapeutics, Inc. and its senior executives for potential violations of federal securities laws, particularly concerning the safety claims of its product Elevidys [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the Southern District of New York, titled Dolgicer v. Sarepta Therapeutics, Inc., et al., No. 25-cv-05317 [2]. - Investors have until August 25, 2025, to request to lead the case [2]. Group 2: Product and Safety Claims - Sarepta is focused on developing treatments for rare diseases, with Elevidys being its primary product for Duchenne muscular dystrophy [3]. - The company allegedly misrepresented the safety profile of Elevidys, claiming its benefits outweighed risks, while it has been linked to fatal acute liver failure in some patients [3]. Group 3: Stock Price Impact - Following the announcement of a patient's death due to acute liver failure on March 18, 2025, Sarepta's stock fell by $27.81, or over 27%, from $101.35 to $73.54 [4]. - A second death announcement on June 15, 2025, led to a further decline of $15.24, or more than 42%, from $36.18 to $20.94 [4]. - A third death related to Elevidys was reported on July 17, 2025, causing the stock to drop by more than 40% on July 18, 2025 [5].

Core Viewpoint - Sarepta Therapeutics has faced significant challenges in 2025, with a dramatic decline in share value due to patient deaths linked to its FDA-approved gene therapy, ELEVIDYS, despite generating over $1 billion in revenue since its approval in June 2023 [1][2]. Financial Performance - As of August 11, 2025, Sarepta's shares have dropped over 85% this year, with a market capitalization falling from approximately $11.61 billion to $1.75 billion [2][6]. - The company reported that 54% of its net product revenue in fiscal 2024 came from products other than ELEVIDYS, indicating diversified revenue streams [7]. FDA Interactions - The FDA initially requested Sarepta to halt shipments of ELEVIDYS after multiple patient deaths were reported, leading to a 36% drop in share price [3]. - Following an investigation, the FDA reversed its request, allowing Sarepta to resume sales to ambulatory patients, who represent 70% to 85% of ELEVIDYS patients [4]. Market Sentiment and Analyst Predictions - Following the FDA's reversal, Sarepta's shares increased by 50% as of August 11, reflecting improved market sentiment [5]. - Analysts from Wells Fargo and BMO Capital Markets have set price targets of $50, suggesting a potential upside of around 179% from the current share price [2]. Valuation Metrics - Sarepta's stock is currently trading at a forward price-to-sales (P/S) ratio of 1.2x, significantly lower than the median P/S ratio of 4.3x among U.S. large-cap pharma and biotech stocks, indicating it may be undervalued [7]. Competitive Landscape - Sarepta faces competition from other companies developing DMD therapies, such as Solid Biosciences, which has a treatment in early-stage trials that may mitigate some risks associated with ELEVIDYS [10][11].