BioCentury
ARTICLE | Product Development

Elevidys timeline raises questions about Sarepta’s and FDA’s decisions and disclosures

Report of fourth death after a week of leaks and conflicting statements adds to confusion for DMD families

July 26, 2025 12:07 AM UTC

There was more disturbing news for Duchenne muscular dystrophy patients Friday as FDA announced an investigation of the death of an 8-year-old boy who had received Sarepta’s Elevidys gene therapy.

The news, like the leaks and statements from Sarepta Therapeutics Inc. (NASDAQ:SRPT) and FDA in recent days, raised questions about the responsibilities of companies and regulators to disclose information about fatal events that are or could be related to a treatment, and highlighted the contentious circumstances surrounding the testing, approval and use of Elevidys...