After deaths and FDA setbacks, Sarepta abandoned LGMD gene therapy, leaving families desperate and patients without ...

Sarepta Therapeutics Inc. landed a deal with investors to restructure around $700 million of debt, giving the company a ...

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

Sarepta Therapeutics obtained traditional FDA approval for ambulatory DMD patients and accelerated approval for non-ambulatory DMD patients with a confirmed mutation in the DMD gene on the 20th of ...

Citi said on Wednesday that the U.S. Food and Drug Administration may take a “more comprehensive look” at the level of ...

A refinancing deal will delay the maturity of $700 million in debt until 2030, allowing the company to “fully fund” its ...

The FDA’s shift on Elevidys sends a message: boldness, scientific rigor and urgency are essential in confronting rare ...

After a second Elevidys patient death from acute liver failure, Sarepta in July launched a major restructuring that involves a 36% mass layoff round and a pivot from gene therapy to small interfering ...

Certain Sarepta Therapeutics Inc. insiders were accused in a stockholder lawsuit of reaping a combined $6.2 million selling ...

In the wake of multiple patient deaths from liver injuries related to Sarepta Therapeutics’ AAV gene therapy platform, some ...

The FDA said Friday it placed that trial on hold. Sarepta noted that the gene therapy involved in the incident uses “a different dose and is manufactured using a different process,” than Elevidys.