Supernus rises on FDA label expansion of ADHD therapy

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• Supernus Pharmaceuticals (NASDAQ:SUPN), a pharma company focused on CNS disorders, is trading ~9% higher in the pre-market Monday after the firm announced that the U.S. Food and Drug Administration (FDA) expanded the indication for its ADHD therapy Qelbree.
• Accordingly, the drug, also known as viloxazine extended-release capsules, will be available for adults aged 18 years and older for the treatment of attention deficit hyperactivity disorder (ADHD).
• The company says that Qelbree is the first novel non-stimulant treatment approved for adults in 20 years.
• The regulatory decision was based on the data from a Phase III trial that met the primary endpoint at doses between 200mg to 600mg.
• Last year, the FDA greenlighted Qelbree for the treatment of pediatric patients with ADHD.