Sarepta Therapeutics Faces Lawsuit Over ELEVIDYS Safety Risks

Sarepta Therapeutics is facing allegations of issuing false and misleading statements regarding its gene therapy, ELEVIDYS, which posed significant safety risks to patients and had undetected severe side effects. The company halted recruitment and dosing due to adverse events. Shareholders who purchased shares during June 22, 2023 to June 24, 2025 are encouraged to contact the Gross Law Firm for possible lead plaintiff appointment.

Sarepta Therapeutics (SRPT) has been embroiled in a series of regulatory and legal challenges following revelations about its gene therapy drug, ELEVIDYS. The company announced a restructuring plan on July 16, 2025, which includes a 36% workforce reduction and annual cost savings of approximately $400 million [1]. This restructuring came amidst growing concerns about the safety of ELEVIDYS and its efficacy in treating Duchenne muscular dystrophy.

ELEVIDYS has been the subject of intense scrutiny following two patient deaths in clinical trials, one from acute liver failure and another from a non-ambulatory patient. These events led Sarepta to suspend shipments and pause dosing in some trials, and prompted the FDA to add a black box warning for acute liver injury and failure [1]. The European Medicines Agency (EMA) subsequently rejected ELEVIDYS due to effectiveness concerns, citing a lack of statistically significant benefits in clinical trials [2].

The company is now facing a securities class action lawsuit, Dolgicer v. Sarepta Therapeutics, Inc., which alleges that Sarepta misled investors about the safety and efficacy of ELEVIDYS [1]. The lawsuit contends that Sarepta failed to disclose significant risks and inadequate clinical trial protocols, leading to a sharp drop in the company's stock price. Investors who purchased shares between June 22, 2023, and June 24, 2025, are encouraged to contact the Gross Law Firm for possible lead plaintiff appointment [1].

The ongoing regulatory and legal challenges highlight the intense scrutiny surrounding novel gene therapies and the material business risks associated with rapid clinical and commercial advancement. Sarepta's updated investment outlook anticipates $1.6 billion in revenue and $275.3 million in earnings by 2028, despite near-term volatility and regulatory scrutiny [2]. However, the company's ability to deliver on this potential is contingent on resolving the safety concerns and legal challenges surrounding ELEVIDYS.

References:
[1] https://www.globenewswire.com/news-release/2025/08/01/3126050/32716/en/Sarepta-Therapeutics-SRPT-Announces-Restructuring-and-ELEVIDYS-Black-Box-Warning-EMA-Recommends-Refusal-of-Marketing-Authorization-Securities-Class-Action-Pending-Hagens-Berman.html
[2] https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-srpt/sarepta-therapeutics/news/sarepta-therapeutics-srpt-faces-renewed-scrutiny-after-elevi