SRPT Update: Hagens Berman Urges Sarepta Investors to Act Before August 25 Deadline

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 defined as June 22, 2023, to June 24, 2025, with a deadline for investors to serve as Lead Plaintiff set for August 25, 2025 [2]. - The lawsuit highlights a timeline of disclosures and stock price declines linked to the drug's safety issues [2]. 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 on a placebo [3]. - This rejection 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: Investigation and Responses - Hagens Berman is investigating claims on behalf of investors who experienced substantial losses, encouraging individuals with relevant information to come forward [4]. - Reed Kathrein, a partner at Hagens Berman, noted that Sarepta's stock has been adversely affected by safety and regulatory news, particularly following the EMA's rejection of ELEVIDYS [5]. - The firm is also looking into whether Sarepta's previous statements and clinical trial protocols adequately reflected the risks associated with the drug [5]. Group 4: Timeline of Events - Key events leading to the lawsuit include a patient death reported on March 18, 2025, followed by an EU review that halted some clinical studies [6]. - A second patient death from acute liver failure was reported on June 15, 2025, leading to the suspension of shipments for certain patient groups [6]. - On June 24, 2025, the FDA confirmed its investigation into the risk of acute liver failure associated with ELEVIDYS [6].