The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

Separately, the FDA on Friday informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, that is approved to treat a different type of muscular dystrophy and was ...

In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The ...

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

Also on Friday, the Food and Drug Administration informally requested that Sarepta voluntarily pause shipments of another gene therapy, Elevidys, which is approved to treat a different type of ...

Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second ...

An unusual public feud between the Food and Drug Administration and a maker of gene therapies for rare diseases could test ...

Sarepta stock (SRPT) declined 5% in premarket trade, after falling 36% on Friday, when it disclosed a patient death due to liver failure.

GlucoTrack repurchased over 90% of its Series A warrants, while Sarepta disclosed a third patient death, suspended Elevidys shipments, and added a black-box warning amid FDA scrutiny.

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

When three patients die after taking a cutting-edge drug, most companies hit the brakes. Not Sarepta Therapeutics. The ...