KemPharm Inc. (NASDAQ: KMPH) shares dipped on Monday after the firm announced topline results from its attention-deficit/hyperactivity disorder (ADHD) clinical trial. While the results were positive, investors ultimately sent shares lower in the session.
Specifically, the results come from the efficacy and safety clinical trial of KP415, which contains serdexmethylphenidate (a prodrug of d-methylphenidate) and d-methylphenidate. The results from the trial indicated that KP415 successfully met the primary efficacy endpoint in patients with ADHD between the ages of six and 12 years.
The firm will be developing additional clinical data for KP415 throughout 2018. Management believes that completing the analysis of the full data set from KP415 trial and other related studies will allow the firm to submit a New Drug Application for KP415 with the FDA in the first quarter of 2019.
Travis Mickle, Ph.D., KemPharm’s president and chief executive, commented:
We are pleased with these top line results from our pivotal trial of KP415. The trial met its pre-specified primary endpoint, which is the mean difference in the SKAMP-Combined score change from baseline across all post-dose time points. Pre-specified secondary endpoints of SKAMP-C change at each time point from the pre-specified, pre-randomization baseline indicated a drug effect from 1 to 10 hours post-dose, and data from the PERMP, PERMP-Attempted and PERMP-Correct all exhibited improvement over placebo from 0.5 hours to 13 hours post-dose. Lastly, KP415 was generally well-tolerated with adverse events (AEs) typical of stimulant therapy.
Shares of KemPharm were last seen down about 3% at $6.55, with a consensus analyst price target of $12.92 and a 52-week range of $2.45 to $8.40.