Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...

Still others wrote letters to the Food and Drug Administration directly. They demanded the FDA restore access to the drug ...

Jefferies analysts said these detailed safety outcomes confirm the gene therapy's positive risk/benefit profile in ambulatory ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died ...

The biotech, which cut jobs following the rejection in May of its Barth syndrome therapy, claimed it has addressed the agency ...

A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.

With a strong launch underway for a bladder cancer gene therapy, Ferring is finding the kind of commercial success that’s ...

Elevidys has fast become Sarepta’s top product. The company reported $820.8 million in Elevidys revenue in 2024, up from $200.3 million in 2023, the year it entered the market.

Liquidating its stake in Arrowhead helps Sarepta cover a milestone payment and secure what one analyst described as ...

Sarepta Therapeutics' Elevidys Gets Approval In Japan To Treat Duchenne Muscular Dystrophy May 13, 2025 — 11:30 am EDT Written by RTTNews.com for RTTNews -> ...

In the U.S., ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age.