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Sarepta Therapeutics (NASDAQ:SRPT) said Monday evening that topline data from a Phase 3 trial called EMBARK for its drug Elevidys in the treatment of Duchenne muscular dystrophy, or DMD, indicated that the study failed to meet its primary endpoint.
Shares of Sarepta were halted at 4:00 p.m. ET ahead of the news.
Sarepta had been testing the drug in pediatric patients aged four to seven with DMD. While the trial failed to meet its primary endpoint, it did achieve statistical significance for all of its secondary endpoints, according to the company.
The company said the results supported submission of an efficacy supplement to its Biologics License Application for the product. It added that the FDA has “indicated openness to reviewing the data for label expansion based on the totality of the evidence from EMBARK.”
Elevidys is currently approved for DMD under the FDA’s accelerated approval pathway, which means that continued approval “may be contingent upon verification of clinical benefit in confirmatory trials," the company said.
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