In the latest of a string of issues Sarepta has faced, the CHMP said it was recommending against approval as the pivotal ...

After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be ...

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

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

Sarepta and Roche face a regulatory setback as the EMA's CHMP issues a negative opinion on Elevidys for Duchenne muscular dystrophy patients.

The third death of a patient on a Sarepta therapy occurred in a 51-year-old man with limb-girdle muscular dystrophy type 2D/R3 who participated in a phase 1 trial. He had not received Sarepta’s ...

Sarepta Therapeutics (SRPT) said late Monday it will pause all shipments of its Duchenne muscular dystrophy gene therapy, Elevidys, in the U.S.

last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments.

Sarepta to pause Elevidys gene therapy shipments in US By Reuters July 21, 20256:38 PM PDTUpdated July 21, 2025 Companies ...