Sarepta Therapeutics (SRPT) Declines Again On EMA Recommendation to Refuse ELEVIDYS Marketing Authorization, Securities Class Action Pending – Hagens Berman

Core Viewpoint - The European Medicines Agency (EMA) recommended the refusal of marketing authorization for Sarepta's ELEVIDYS, leading to a significant decline in the company's stock price [1][2]. Group 1: Regulatory and Clinical Developments - The EMA concluded that ELEVIDYS lacked efficacy, as a key study involving 125 children showed no significant improvement in movement abilities compared to a placebo group [4]. - The EMA's recommendation follows a series of negative events for Sarepta, including patient deaths and a black box warning for acute liver injury and failure on the ELEVIDYS label [2][4]. Group 2: Legal and Financial Implications - A securities class action lawsuit has been filed against Sarepta, alleging that the company made misleading statements regarding the safety and efficacy of ELEVIDYS, which misled investors about its regulatory prospects [5][6]. - The lawsuit claims that Sarepta failed to disclose significant safety risks associated with ELEVIDYS and inadequacies in clinical trial protocols [6]. - The timeline of disclosures includes patient deaths and safety updates that triggered sharp declines in Sarepta's stock price, with the FDA confirming an investigation into acute liver failure risks associated with the drug [7][8][9]. Group 3: Investor Actions and Investigations - Hagens Berman, a national shareholders rights firm, is investigating the legal claims and encourages affected investors to submit their losses [3][11]. - The firm is also seeking information from individuals who may assist in the investigation regarding Sarepta's disclosures and the efficacy of ELEVIDYS [11].