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 ...

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.

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

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

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 ...

In the U.S., ELEVIDYS is indicated for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in ...

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 -> ...

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

ELEVIDYS is indicated in U.S. for the treatment of Duchenne muscular dystrophy (DMD) in individuals at least 4 years of age. For patients who are ambulatory and have a confirmed mutation in the ...

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