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Sarepta Shares Fall After Gene Therapy Hits Another Regulatory Roadblock
Separately, Sareptea said last week that it would pause the development of most of its experimental gene therapies for a different type of muscular dystrophy. The stoppage came after one of the therapies was linked to the death of a 51-year-old man last month.
Sarepta Therapeutics suffered another major setback on Friday as Europe's drug regulator decided not to recommend the ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
The drug, which was designed to treat Duchenne muscular dystrophy, has been linked to the deaths of two teenage boys.
Europe's medicines regulator did not recommend the approval of Sarepta Therapeutics' gene therapy Elevidys for a type of rare ...
Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
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