By Adriano Marchese
Sarepta Therapeutics shares were sharply higher in premarket trading on Friday after it said the U.S. Food and Drug Administration accepted and filed its efficacy supplement to the application for its treatment of Duchenne muscular dystrophy.
During premarket trading, the shares were trading over 12% higher at $140.
The biopharmaceutical company said the FDA has granted the efficacy supplement a priority review for Elevidys with a review goal date of June 21 of this year.
The intentions for the efficacy supplement are to expand the labeled indication for the treatment, and to convert the accelerated approval to a traditional approval, and Sarepta said the FDA will now evaluate removing age and ambulation restrictions and converting the approval status.
Write to Adriano Marchese at [email protected]
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