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Wednesday, July 25, 2018

Sarepta Muscular Dystrophy study halted by FDA


Sarepta Therapeutics Inc. SRPT, -0.03% shares fell in after-hours trading Wednesday, when the company announced a study of a potential drug for Duchenne Muscular Dystrophy had been halted by the Food and Drug Administration. The study of a potential gene-therapy approach to the disease “has been placed on clinical hold due to the presence of a trace amount of DNA fragment in research-grade third-party supplied plasmid,” the company noted. Sarepta said it still plans to begin dosing patients in the study by the end of the year as long as the FDA accepts its plans to address the issue. Sarepta planned to hold a conference call at 5 p.m. Eastern time to address the issue. Sarepta shares initially fell more than 9% after the news was released, but declines soon settled to about 5.5%.

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