Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...

Separately, Sareptea said last week that it would pause the development of most of its experimental gene therapies for a different type of muscular dystrophy. The stoppage came after one of the ...

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an ...

Wall Street analysts warn that if Sarepta Therapeutics doesn't resolve the Elevidys issues, it could jeopardize its ability to repay debt in 2027.

Ascendis’ likely approval of TransCon CNP for achondroplasia poses a major threat to BioMarin’s best-selling drug. Read why I ...

Roche AG’s Genentech unit disclosed outcomes of two studies testing IL-33-targeting astegolimab vs. placebo on top of standard-of-care maintenance therapy in subjects with moderate to very severe ...

Sarepta Therapeutics shares closed over 5.3% lower on Monday, hitting more than a nine-year low, and fell another 8.5% in ...

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.

H.C. Wainwright sets a rare $0 target for Sarepta Therapeutics amid FDA scrutiny over its Duchenne muscular dystrophy gene therapy Elevidys. Read more here.

While Sarepta has now consented to the FDA’s request to stop selling Elevidys, the company’s brief standoff with the agency ...

The Sarepta saga continues, with the FDA slapping a clinical hold across all of the company’s investigational limb-girdle ...

The FDA requested Sarepta voluntarily stop distributing Elevidys after the death of a third patient who received one of the firm's gene therapies.