Shares of Sarepta Therapeutics declined 17% in early trading on Friday after another patient who had received an experimental ...

Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a ...

After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...

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

A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to the company's gene therapies ...

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the ...

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due ...

The death of a 51-year-old man in the study follows two other deaths of Duchenne patients treated with Sarepta’s marketed gene therapy Elevidys.

Children’s Hospital Los Angeles paused Sarepta’s Elevidys gene therapy after FDA flagged safety issues, including deaths in ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Sarepta pauses U.S. Elevidys shipments to complete FDA-requested safety label updates, aiming to resume distribution in the fourth quarter.