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

The stock has been in free fall since safety issues derailed a gene therapy analysts had expected to achieve blockbuster ...

The deaths prompted the FDA to ask Sarepta to stop shipping Elevidys for all patients, but the company refused to do so. Days later, it changed tack in order to maintain what it said was a “positive ...

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

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

Sarepta Therapeutics said Friday that the deaths of two patients taking its marketed gene therapy Elevidys® (delandistrogene ...

Sarepta (SRPT), in a letter dated August 14 to the FDA, responded to the Citizen Petition related to Elevidys. The letter states in part: “The Petition misrepresents the number of treatment-related ...

Sarepta Therapeutics Inc.’s shares soared after the US biotech reported revenue that beat estimates, which analysts ...

Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook.

Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics ...

Sarepta reported a quarter-on-quarter dip in sales for its Duchenne gene therapy. Elsewhere, Jazz won FDA approval of a brain ...