PTC Therapeutics (PTCT) said Wednesday that a new drug application for vatiquinone for the treatment of adults and children with Friedrich's ataxia has been accepted by the U.S. Food and Drug Administration for priority review.
The agency has set Aug. 19 as the target action date for the drug under the Prescription Drug User Fee Act.
Data from three studies showed that vatiquinone demonstrated "significant" evidence of slowing disease progression with regard to key aspects of the neuromuscular disease, the company said.
Shares were 3.3% higher in recent premarket activity.
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