Sarepta’s Duchenne Treatment Sparks FDA Concerns and Delays

Regulators ordered Sarepta Therapeutics to stop shipping a gene therapy for Duchenne muscular dystrophy, citing reports of troubles that had been circulating on social media for months. The company had already disclosed two deaths linked to its Elevidys treatment, but analysts, FDA records, and patient advocates say there was little information available about the issues before the health regulators intervened.

Source: https://www.bloomberg.com/news/articles/2025-07-22/sarepta-pulls-elevidys-shipment-after-fda-battle-over-duchenne-drug