Shares of KemPharm Inc. exploded 93% in Wednesday’s pre-market trading session after the US Food and Drug Administration (FDA) approved its treatment for attention deficit hyperactivity disorder (ADHD) in patients age six years and older.
Specifically, the FDA approved KemPharm’s (KMPH) New Drug Application (NDA) for Azstarys, formerly referred to as KP415, a once-daily product for the treatment of ADHD. The developer of proprietary prodrugs engineered the candidate as a treatment for ADHD with its partner Gurnet Point Capital (GPC). Following the FDA decision, Corium, a portfolio company of GPC, will lead the commercialization of Azstarys, and expects to make the treatment available in the US as early as in the second half of 2021.