Shares of Sarepta Therapeutics surged Tuesday morning after the company said it had been informed by the Food and Drug Administration that it could resume shipping a drug it paused sales of last week.

Sarepta Therapeutics failed to win the European drug regulator's backing for its muscle disorder gene therapy on Friday, as ...

Sarepta has suffered another regulatory setback after the European Medicines Agency’s (EMA’s) Committee for Medicinal ...

Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...

Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 13% on Friday after a major regulatory blow in Europe. The European ...

Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.

Europe's medicines regulator did not recommend the approval of Sarepta Therapeutics' gene therapy Elevidys for a type of rare ...

Sarepta stock fell after it agreed to voluntarily halt shipments of its experimental medicine Elevidys for Duchenne muscular ...

FDA is investigating Sarepta's Elevidys after two deaths from liver failure in non-ambulatory DMD patients, raising safety and regulatory concerns.

Liver safety has been a concern with gene therapies like ELEVIDYS, which Sarepta acknowledges causes elevated liver enzymes in about 30% of patients—a potential sign of liver stress or injury.

Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...

Sarepta's stock drops on ELEVIDYS safety concerns, yet potential remains for ambulatory patients. Click here to read an analysis of SRPT stock now.