A new report saying Serepta would need to conduct new studies in order to show the FDA that its musculardrophe drug Elevus is safe. And just this morning, EU regulators not recommending approval of that treatment. As a result, that stock is down another 13%.Joining us right now on that and what to expect from the other biotech names reporting next week is Saline Richtor, lead biotech analyst at Goldman Sachs. and Saline, let's go ahead and start with the news of the day since it's out with Surrepta. Um, jus ...

Sarepta shares drop 14% in premarket trading after its gene therapy fails to get EU regulator approval https://t.co/4inyYyirFu ...

Core Viewpoint - The Gross Law Firm is notifying 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 - 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 [3]. - Specific allegations 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]. - The misleading statements resulted in a lack of reasonable basis for the company's positive claims about the therapy [3]. 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 of August 25, 2025, to seek lead plaintiff status [4]. - Participants will be enrolled in a portfolio monitoring system to receive updates on the case's progress [4]. - There is no cost or obligation for shareholders to participate in the class action [4]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and fraud [5]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors affected by misleading statements that inflate stock prices [5].

NEW YORK, July 24, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Sarepta Therapeutics, Inc. (NASDAQ: SRPT).Shareholders who purchased shares of SRPT during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/sarepta-loss-submission-form/?id=157768&from=4CLASS PERIOD: June 22, 2023 to J ...

NEW YORK, July 24, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against Sarepta Therapeutics, Inc. (NASDAQ: SRPT) and certain of the Company’s senior executives for potential violations of the federal securities laws. If you invested in Sarepta, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases-investigations/sarepta-therapeutics-inc-class-action. Investors have until August 25, 2025, to as ...

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]