Sarepta Stock Plunges 16.54% Amid FDA Safety Concerns

On July 25, 2025, Sarepta's stock experienced a significant drop of 16.54% in pre-market trading.

Sarepta Therapeutics has faced a series of challenges recently, primarily stemming from regulatory concerns over its gene therapy, Elevidys. The FDA has reportedly requested additional clinical testing to validate the safety profile of Elevidys, following reports of patient deaths linked to liver injury, a known side effect of the therapy. This has led to a significant drop in Sarepta's stock price, with investors expressing concerns over the company's future prospects.

The FDA's decision to place an immediate clinical hold on Sarepta's investigational gene therapy trials for limb girdle muscular dystrophy, following the three deaths, underscores the agency's seriousness about the safety of the treatments. The FDA also revoked the company's platform technology designation and requested Sarepta to voluntarily halt shipments of Elevidys. However, Sarepta refused to comply with these demands, stating that it believes in access to drugs for unmet medical needs and that it plans to keep the drug available for younger patients with Duchenne's who have earlier stages of the disease.

The latest developments have sparked criticism from financial analysts, with some suggesting that those involved should be prosecuted. Despite the potential investment in Sarepta Therapeutics, conviction lies in AI stocks with greater promise for returns and limited downside risk. Investors have been urged to exercise caution and consider the implications of the FDA's actions on Sarepta's future prospects. The company's history of facing scrutiny and criticism over its drug approvals and clinical trial protocols has also contributed to the market's concerns. As Sarepta continues to navigate these challenges, investors should closely monitor the company's progress and regulatory interactions.