US regulators are investigating the death of an 8-year-old boy in Brazil who received Sarepta Therapeutics Inc.’s Elevidys.

Sarepta Therapeutics Inc. has refused to pause all shipments of its Elevidys treatment after three deaths were linked to the ...

European regulators said that a Duchenne gene therapy should not be approved, imperiling the treatment that is also facing ...

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

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

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

Roche Holding AG temporarily halted shipments of its muscular disorder gene therapy, Elevidys, outside the U.S., mirroring its U.S. partner Sarepta Therapeutics. The pause affects orders relying on ...

FDA investigates patient deaths after treatment with Sarepta's Duchenne gene therapy Elevidys By Angus Liu Jun 25, 2025 10:26am Sarepta Therapeutics gene therapy U.S. FDA FDA investigation ...

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

Nevertheless, on the same day, Sarepta assured investors that “the benefit-risk of ELEVIDYS remains positive.” Next, on June 15, 2025, Sarepta announced that a second patient treated with ...