Sarepta Therapeutics (SRPT) Announces Restructuring and ELEVIDYS Black Box Warning, EMA Recommends Refusal of Marketing Authorization, Securities Class Action Pending – Hagens Berman

Core Insights - Sarepta Therapeutics announced a major restructuring involving a 36% workforce reduction, equating to 500 employees, aimed at saving approximately $400 million annually [1] - The FDA has mandated a black box warning for Sarepta's gene therapy drug, ELEVIDYS, due to risks of acute liver injury and acute liver failure [1] Legal Issues - A securities class action lawsuit has been filed against Sarepta, representing investors who acquired securities between June 22, 2023, and June 24, 2025 [2][4] - The lawsuit alleges that Sarepta misled investors regarding the safety and efficacy of ELEVIDYS, claiming the company portrayed the drug as safe while withholding critical risk information [4][5] Safety Concerns - The lawsuit highlights that Sarepta failed to disclose significant safety risks associated with ELEVIDYS and inadequacies in clinical trial protocols [5] - A timeline of events indicates that Sarepta reported a patient death during a trial on March 18, 2025, followed by further disclosures of deaths and regulatory scrutiny [6][7][8] Regulatory Scrutiny - On July 25, 2025, the European Medicines Agency rejected ELEVIDYS due to questions about its effectiveness, leading to a further decline in Sarepta's stock price [9]