Sarepta investors sue over gene therapy safety concerns and regulatory setbacks.

A securities class-action lawsuit has been filed against Sarepta Therapeutics due to safety concerns and regulatory setbacks for its gene therapy, ELEVIDYS. The lawsuit alleges that Sarepta misled investors about the drug's safety and effectiveness. Investors with losses can submit their claims by August 25, 2025. The lawsuit covers the period from June 22, 2023 to June 24, 2025.

Sarepta Therapeutics, Inc. (SRPT) is facing a securities class action lawsuit due to safety and efficacy concerns surrounding its gene therapy, ELEVIDYS. The lawsuit alleges that Sarepta misled investors about the drug's safety and approval prospects. Investors with substantial losses can submit their claims by August 25, 2025.

The lawsuit, filed by Dolgicer v. Sarepta Therapeutics, Inc., covers the period from June 22, 2023, to June 24, 2025. It alleges that Sarepta misrepresented the safety and effectiveness of ELEVIDYS, potentially damaging investor trust. The complaint claims that Sarepta withheld crucial information about significant safety risks, which could lead to regulatory scrutiny and trial halts [1].

Sarepta's stock price has declined significantly due to these safety issues and halted trials. The company's stock experienced sharp declines after disclosures of patient deaths and regulatory scrutiny [2]. The European Medicines Agency (EMA) rejected ELEVIDYS' marketing authorization, concluding that the drug failed to demonstrate clear benefits for patients with Duchenne muscular dystrophy [1].

The EMA's decision was based on data from a pivotal trial involving 125 children aged 4 to 7, which showed no significant difference in movement improvement between those who received ELEVIDYS and those who were given a placebo [1]. Sarepta has since agreed to a black box warning for acute liver injury and acute liver failure in ELEVIDYS's label [2].

Hagens Berman, a national shareholders rights firm, is leading the investigation into the lawsuit's legal claims and urges Sarepta investors who suffered substantial losses to submit their losses now. The firm also encourages persons with knowledge who may assist in the investigation to contact its attorneys [1].

Sarepta must navigate these challenges to maintain its financial stability and market position. The company is currently restructuring and implementing cost-cutting measures, including a 36% workforce reduction [2].

References:
[1] https://www.globenewswire.com/news-release/2025/08/18/3135187/32716/en/Sarepta-Therapeutics-SRPT-August-25-2025-Lead-Plaintiff-Deadline-Approaching-SRPT-Investors-with-Substantial-Losses-Encouraged-to-Contact-Hagens-Berman.html
[2] https://www.globenewswire.com/news-release/2025/08/15/3134377/32716/en/Sarepta-Therapeutics-SRPT-Declines-Again-On-EMA-Recommendation-to-Refuse-ELEVIDYS-Marketing-Authorization-Securities-Class-Action-Pending-Hagens-Berman.html