KemPharm, Inc. (KMPH - Free Report) announced positive top-line results from a pivotal study, evaluating the efficacy and safety of its investigational candidate, KP415, for the treatment of attention deficit/hyperactivity disorder (ADHD) in pediatric patients.
KP415 met primary and secondary endpoints in the KP415.E01 study. The double-blind placebo-controlled study (n=150) on KP415 was conducted on children with ADHD in the age bracket of six to 12 years. Patients having received KP415 showed a significant statistical improvement on the Swanson, Kotkin, Agler, M-Flynn and Pelham (“SKAMP”) scale as well as the Permanent Product Measure of Performance (“PERMP”) scale. Both SKAMP and PERMP scales are the most commonly used parameters to assess the functional impairment related to ADHD in pediatric patients.
KP415 was generally well-tolerated with adverse events typical of a stimulant therapy. The company plans to develop and analyze the full-data set from KP415.E01 trial and also submit a new drug application for KP415 in the first quarter of 2019. Additionally, the candidate is being evaluated in oral and intranasal Human Abuse Potential studies. Findings from the same might also be included in the regulatory application.
However, despite the positive study outcome, shares of KemPharm have declined nearly 7% on Monday. The stock has soared 54.4% year to date compared with the industry’s increase of 3.2%.
KemPharma currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the same sector include Taro Pharmaceutical Industries Ltd. (TARO - Free Report) , Summit Therapeutics PLC (SMMT - Free Report) and ChemoCentryx, Inc. (CCXI - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here
Taro Pharmaceutical’s earnings estimates have moved 13% north for 2019 and 12.4% for 2020 over the past 60 days. The stock has gained 10.6% so far this year.
Summit Therapeutics’ loss per share estimates have been narrowed by 33.4% for 2019 and 42.8% for 2020 over the past 60 days.
ChemoCentryx’s loss per share estimates have been narrowed by 24.8% for 2018 and 0.8% for 2019 over the past 60 days. The stock has skyrocketed 130.6% so far this year.
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