Sarepta Therapeutics Plunges 10.68% as Legal and Regulatory Challenges Drive Shares to 380th in Trading Volume

Sarepta Therapeutics (SRPT) plunged 10.68% on August 25, 2025, with a trading volume of $240 million, ranking 380th in market activity. The decline followed escalating legal and regulatory challenges surrounding its gene therapy ELEVIDYS. Multiple class-action lawsuits allege the company concealed safety risks, including patient deaths and halted trials, while the FDA and European Medicines Agency (EMA) scrutinized the therapy’s safety and efficacy. EMA’s rejection of ELEVIDYS in July 2025, citing insufficient clinical evidence, further compounded the crisis.

The stock has lost 86% of its value over the past year amid ongoing safety concerns and administrative hurdles. Despite analysts estimating a 15% undervaluation compared to fair value, the company’s ability to rebound hinges on resolving legal disputes and regaining regulatory trust. Recent safety disclosures, including a fatal case linked to influenza in an ELEVIDYS patient, have fueled investor skepticism. Sarepta’s cost-cutting measures, including a 36% workforce reduction, reflect the financial strain from litigation and stalled revenue growth.

Biotech sector trends highlight Sarepta’s vulnerability to litigation-driven valuation declines. In 2025, 21.1% of federal securities lawsuits targeted firms for regulatory missteps or overpromising, with Sarepta’s case emblematic of the risks in precision medicine. The company’s path forward depends on FDA approval for revised safety protocols, legal resolution of ongoing lawsuits, and rebuilding credibility with stakeholders. For now, the stock’s trajectory remains uncertain, with valuation models balancing speculative optimism against persistent operational and legal headwinds.

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