News

Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe ...
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
Sarepta Therapeutics, Inc. faces setbacks with Elevidys, safety issues, and workforce cuts, raising concerns about its ...
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The ...
Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators ...
Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...
A 51-year-old man died last month after receiving an experimental treatment from Sarepta, the third death this year tied to ...
Children’s Hospital Los Angeles paused Sarepta’s Elevidys gene therapy after FDA flagged safety issues, including deaths in ...
Pharmaceutical Technology on MSN3d
CHMP rejects Elevidys in latest setback for Sarepta
Sarepta said it accepts the CHMP decision on Elevidys, while partner Roche said it will continue working with the EMA.
CHMP issues negative opinion on conditional marketing authorization for Roche’s gene therapy, Elevidys for Duchenne muscular dystrophy: Basel Monday, July 28, 2025, 15:00 Hrs [I ...
Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced a ...