As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

Pharma FDA investigates patient deaths after treatment with Sarepta's Duchenne gene therapy Elevidys By Angus Liu Jun 25, 2025 10:26am Sarepta Therapeutics gene therapy U.S. FDA FDA investigation ...

Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...

Sarepta will share the panel’s recommendations with the U.S. Food & Drug Administration (FDA), and implementation of any new regimen will be subject to FDA guidance and allowance. In the ...

The rAAVrh74 viral vector is a key component in several of Sarepta’s gene therapy programs, including Elevidys, an already FDA-approved gene therapy for Duchenne muscular dystrophy. It is also ...

U.S. FDA Grants Platform Technology Designation to the Viral Vector Used in SRP-9003, Sarepta’s Investigational Gene Therapy for the Treatment of Limb Girdle Muscular Dystrophy Type 2E/R4 ...

FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...

In June, Sarepta reported a second death in a patient who had received its gene therapy, which raised concerns about the safety and future demand for the treatment. Both boys were non-ambulatory ...