Core Viewpoint - Sarepta Therapeutics, Inc. experienced a significant decline in share price following the report of a third patient death related to its experimental gene therapy, ELEVIDYS, leading to a 36% drop in stock value on July 18, 2025 [1]. Legal Developments - A securities class action lawsuit has been filed against Sarepta, representing investors who acquired securities between June 22, 2023, and June 24, 2025 [2]. - The lawsuit focuses on Sarepta's disclosures regarding the safety and efficacy of ELEVIDYS, alleging that the company misled investors about the therapy's safety and potential for broader application [4]. Safety Concerns - The complaint highlights that Sarepta failed to disclose critical information regarding the safety of ELEVIDYS, with the first indication of issues arising on March 18, 2025, when a patient death was reported [5]. - Subsequent disclosures included a second patient death on June 15, 2025, and a safety communication from the FDA on June 24, 2025, which investigated the risk of acute liver failure associated with ELEVIDYS [7][8]. Regulatory Actions - Following the reported deaths, the FDA placed Sarepta's clinical trials for both ELEVIDYS and another investigational gene therapy, SRP-9004, on clinical hold [10]. - The company faced increased regulatory scrutiny and was compelled to halt patient recruitment and dosing in its clinical studies due to the severity of adverse events [8]. Financial Impact - The financial press reported a drastic reduction in Sarepta's price target to $0 by H.C. Wainwright following the adverse developments [10].

Core Viewpoint - A class action securities lawsuit has been filed against Sarepta Therapeutics, Inc. due to alleged securities fraud affecting investors between June 22, 2023, and June 24, 2025 [1] Group 1: Lawsuit Details - The lawsuit claims that Sarepta made false statements regarding the safety of its gene therapy ELEVIDYS for Duchenne, which posed significant risks to patients [2] - It is alleged that the trial protocols for ELEVIDYS failed to identify severe side effects, leading to potential regulatory scrutiny and risks regarding the therapy's approvals [2] - The complaint asserts that the defendants misled investors with positive statements that lacked a reasonable basis due to the severity of adverse events from ELEVIDYS treatment [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, with no obligation to participate [3] Group 3: Firm Background - Levi & Korsinsky has a history of securing hundreds of millions of dollars for shareholders and has extensive expertise in complex securities litigation [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the U.S. [4]

Group 1 - The Growth Stock Forum focuses on identifying attractive growth stocks, particularly in the biotech sector, emphasizing risk/reward situations [1][2] - The forum features a model portfolio consisting of 15-20 stocks, regularly updated, along with a top picks list of up to 10 stocks expected to perform well in the current calendar year [2] - The forum provides trading ideas targeting both short-term and medium-term market movements, along with community engagement for discussions and questions [2]

There were warnings to the FDA about Sarepta before US regulators asked the company to halt shipments of its gene therapy https://t.co/ZZC0xgoUpS ...

Core Insights - Sarepta Therapeutics (SRPT) is experiencing a decline in share price following the announcement of a voluntary and temporary halt to all U.S. shipments of its gene therapy Elevidys, which is designed for Duchenne muscular dystrophy (DMD) [1][3] Company Developments - The pause in shipments is a proactive measure to address information requests and complete the safety labeling supplement process with the FDA, indicating the company's commitment to a science-based review [2][8] - Elevidys has been a significant revenue driver for Sarepta, contributing over half of the company's total revenues in Q1 2025, and the halt is expected to have a substantial negative impact on financial performance in the latter half of the year [3][8] - The decision to halt shipments follows the death of a patient in a clinical trial, marking the third patient death linked to Sarepta's gene therapies, which raises serious safety concerns [4][5][6] Regulatory Actions - The FDA has placed all of Sarepta's clinical studies for limb-girdle muscular dystrophy (LGMD) on hold due to the patient deaths associated with acute liver failure (ALF) [6][7] - The agency requested the voluntary stop of Elevidys shipments, which Sarepta initially resisted but ultimately complied with [7][8] Financial Restructuring - In response to the challenges, Sarepta announced a major restructuring plan that includes cutting 36% of its workforce, approximately 500 employees, to achieve annual savings of $120 million, alongside a reprioritization of its pipeline to save an additional $300 million per year [12][14] - The company is now focusing on its siRNA pipeline, which was acquired through a recent deal with Arrowhead Pharmaceuticals, targeting various conditions and expecting initial clinical data by year-end [14] Market Performance - Year-to-date, Sarepta's shares have plummeted by 89%, contrasting sharply with the industry's modest decline of 2.2% [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 Impact - 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]. - Following the announcement of patient deaths related to Elevidys, Sarepta's stock experienced significant declines, with a drop of over 27% on March 18, 2025, and a further decline of more than 42% on June 16, 2025 [4][5]. Legal Proceedings - The case is pending in the U.S. District Court for the Southern District of New York, with investors having until August 25, 2025, to seek appointment as lead plaintiffs [2].

Sarepta announced that the company plans to temporarily pause all shipments of its gene therapy to treat Duchenne muscular dystrophy, Elevidys, in a reversal of its prior stance https://t.co/RqYHvvW5xV ...

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 allegations spans 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 significant safety risks associated with ELEVIDYS, failure of trial protocols to detect severe side effects, and the potential halting of recruitment and dosing in trials due to adverse events [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's status [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 the rights of investors who have suffered losses due to deceit and illegal business practices [5]. - The firm emphasizes the importance of responsible business practices and seeks recovery for investors affected by misleading statements that inflated stock prices [5].

Group 1 - The U.S. FDA has placed Sarepta Therapeutics Inc.'s SRPT investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) on clinical hold due to serious safety concerns, including three patient deaths potentially linked to the products [1] - The FDA has requested Sarepta to voluntarily halt all shipments of Elevidys, the company's approved gene therapy, but Sarepta has refused this request [2] - Analysts from Needham have downgraded Sarepta from Hold to Underperform, expressing concerns that the FDA's feedback puts Elevidys' future in jeopardy and may challenge the company's ability to meet its 2027 debt obligations [3][4] Group 2 - William Blair views the FDA's announcement as a worst-case scenario for Sarepta, potentially affecting patient interest in Elevidys and indicating a fractured relationship with the FDA [5] - William Blair maintains a Market Perform rating for Sarepta, suggesting that Elevidys will not be formally withdrawn from the market, but anticipates a delayed BLA submission for SRP-9003 and lower commercial adoption of Elevidys [6] - Other analysts have also downgraded Sarepta, with Mizuho lowering the price forecast from $40 to $14, and Piper Sandler reducing it from $32 to $18 [7]

Regulatory Action - Sarepta Therapeutics rejects FDA's request to halt shipments of its muscular dystrophy drug [1]