Core Viewpoint - Sarepta Therapeutics is facing a securities class action lawsuit due to safety concerns regarding its gene therapy ELEVIDYS, which is intended for treating Duchenne muscular dystrophy, following a negative assessment from European regulators [1][6][5]. Group 1: Regulatory Challenges - European drug regulators concluded that ELEVIDYS did not demonstrate clear benefits for patients, as a pivotal trial involving 125 children showed no significant difference in movement improvement compared to a placebo [3][4]. - The European Medicines Agency (EMA) cited concerns about the therapy's effectiveness and safety, ultimately determining that Sarepta did not provide sufficient evidence for broader approval [5]. Group 2: Legal Implications - A securities class action lawsuit alleges that Sarepta misled investors regarding the safety and efficacy of ELEVIDYS, claiming the company withheld critical information about significant safety risks [6][7]. - The lawsuit contends that disclosures about patient deaths during clinical trials led to a sharp decline in Sarepta's stock price, indicating that investors were not adequately informed about the risks associated with the drug [10][9]. Group 3: Investor Actions - The deadline for Sarepta investors who suffered losses to be considered as Lead Plaintiff in the class action is August 25, 2025, prompting a call for affected investors to submit their losses [2][3]. - Hagens Berman, the law firm leading the investigation, is looking into whether Sarepta's statements about ELEVIDYS were misleading in light of the recent findings from the EMA [12].
Sarepta Therapeutics (SRPT) August 25, 2025 Lead Plaintiff Deadline Approaching, SRPT Investors with Substantial Losses Encouraged to Contact Hagens Berman