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

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

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

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

While the 51-year-old man with limb girdle muscular dystrophy who died most recently was not taking Elevidys, his experimental therapy and Elevidys are based on similar gene technology, the FDA said.

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 ...

July 18 (Reuters) - U.S. regulators asked Sarepta Therapeutics (SRPT.O) on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a ...

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

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

Despite an FDA request to halt shipments, Sarepta Therapeutics (NASDAQ:SRPT) announced late Friday that the company will continue to ship its gene therapy Elevidys, developed with Roche (OTCQX ...

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.

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