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Biotech Stocks Facing FDA Decision In April 2021

Supernus Pharmaceuticals
Supernus Pharmaceuticals

Supernus Pharmaceuticals Inc.’s (SUPN) SPN-812, being developed for the treatment of attention deficit hyperactivity disorder in pediatric patients, is at the FDA altar for the second time, with a decision expected in early April 2021.

Last November, the regulatory agency refused to approve SPN-812, following the company’s decision to move its in-house laboratory that conducts analytical testing to a new location. However, no safety or efficacy issues were identified by the FDA then.

SPN-812 is a novel non-stimulant and its active ingredient is Viloxazine hydrochloride which was previously marketed in Europe for many years as an antidepressant.

If approved, SPN-812 will compete with Eli Lilly’s (LLY) Strattera and Shire Plc’s Intuniv.

Analysts have predicted peak annual sales of SPN-812 to be in the range of $400 million to $600 million by 2025.

SUPN closed Friday’s (Mar.26, 2021) trading at $26.23, up 0.19%.