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.
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We are a rare disease therapeutics company leading with science to make life-changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners and advocacy groups in all of our clinical and regulatory development strategies.
With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed. By following the data without bias, our transparent narratives and common-sense perspective have successfully overcome complex development challenges to make much-needed therapies available to patients.