Supernus Pharmaceuticals Inc. (NASDAQ: SUPN) shares dipped on Thursday despite the firm posting positive results from two of its late-stage studies for the treatment of attention deficit hyperactivity disorder (ADHD) in children.
Specifically, these topline results came from two pivotal Phase 3 studies of SPN-812.
Both trials were successful in achieving the primary endpoint, with SPN-812, at daily doses of 100 mg and 200 mg in study P301 and 200 mg and 400 mg in study P303. Robust statistical significance in improvement in the symptoms of ADHD from baseline to end of study as measured by the ADHD Rating Scale-5 was achieved. Both active doses in each study were well tolerated.
Looking ahead, the company expects to announce topline data from study P302, the first adolescent Phase 3 trial of SPN-812, by the end of December 2018. Topline data from the second adolescent Phase 3 trial, P304, are expected by the end of the first quarter of 2019.
Supernus expects to submit a New Drug Application (NDA) for SPN-812 in the second half of 2019, and to launch it, pending U.S. Food and Drug Administration (FDA) approval, in the second half of 2020.
Jack Khattar, president and CEO of Supernus, commented:
These are very exciting data demonstrating the important role we believe SPN-812 can play in treating patients with ADHD. We believe these data from the two pivotal Phase III studies, which are consistent with the Phase IIb data, demonstrate that SPN-812 is a well-differentiated novel non-stimulant treatment option for many children with ADHD.
Shares of Supernus were last seen down 12% at $40.35, in a 52-week range of $34.90 to $61.25. The stock has a consensus analyst price target of $59.70.