FDA Approves Supernus’ Qelbree; Shares Rise 10% Pre-Market

Supernus Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for Qelbree, its treatment for attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 17. Shares are up about 10% in Monday’s pre-market session.

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Supernus Pharmaceuticals (SUPN) President and Chief Executive Officer, Jack A. Khattar, said, “Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD. Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile.”

Andrew J. Cutler, M.D., Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University, and Chief Medical Officer, Neuroscience Education Institute, noted, “ADHD is one of the most common mental health issues in the U.S. The right treatment is key for children and adolescents, as they grow and navigate school and social relationships. This approval offers a novel once a day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD.” (See Supernus Pharmaceuticals stock analysis on TipRanks)

This approval is based on four Phase 3 clinical trials featuring more than 1,000 patients aged 6 to 17. The treatment is the first novel stimulant treatment for the disease in more than a decade, and Supernus plans to commercialize it in the U.S. in 2Q.

Furthermore, Supernus is also evaluating Qelbree in adults. It reported positive Phase 3 results in adult patients with ADHD in December 2020 and a supplemental new drug application (sNDA) is expected in 2H21.

Recently, Piper Sandler analyst David Amsellem reiterated a Buy rating on the stock and raised its price target to $35 (31% upside potential) from $30.

Amsellem argues that contribution from SPN-812 positions Supernus for “significant” EBITDA growth beyond the loss of Trokendi XR exclusivity in early 2023.