KemPharm, Inc . KMPH announced positive top-line results from second of three human abuse potential (HAP) studies of serdexmethylphenidate (SDX), the prodrug contained in KemPharm's lead pipeline candidate, KP415.
KP415 is being developed for the treatment of attention deficit/hyperactivity disorder (ADHD).
Data from the double-blind, placebo-controlled phase I study showed that KP415 prodrug may have lower abuse potential compared with Novartis' NVS Focalin XR (dexmethylphenidate extended release capsules), even when given in oral doses up to 1.5 times higher.
The company believes that results from this study as well as the previously reported intravenous HAP data indicate that SDX produces far less desirable pharmacodynamic effects to abusers compared with d-methylphenidate, when injected or taken orally as Focalin XR.
Importantly, KP415 prodrug demonstrated statistically significantly lower drug liking, even at higher doses of120 mg and 240 mg compared with FocalinXR at 80 mg.
Despite positive results from the study, shares of KemPharm have declined more than 7% on Tuesday. However, the stock has rallied 19.8% year to date against the industry's decline of 0.1%.
KemPharm remains on course to present data from the final HAP study, which is evaluating the abuse potential of SDX through the intranasal route. Depending on the outcome of the data, the company plans to submit a new drug application (NDA) for KP415, with submission to the FDA expected in the first quarter of 2019. Simultaneously, a parallel active partnering process for KP415 and KP484 is also underway.
We would like to remind investors that in July, KemPharm announced positive top-line results from a pivotal study, evaluating the efficacy and safety of KP415, for the treatment of ADHD in pediatric patients. KP415 met primary and secondary endpoints in the KP415.E01 study. Findings from the same might also be included in the regulatory application.
KemPharm, Inc. Price and Consensus
Zacks Rank & Stocks to Consider
KemPharma currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the same sector are BioSpecifics Technologies Corp. BSTC and Pacira Pharmaceuticals, Inc. PCRX , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .
BioSpecifics' earnings estimates for 2018 and 2019 have moved 9.1% and 11.7% north, respectively, over the past 60 days. The stock has surged 40.2% year to date.
Pacira's earnings estimates for 2018 and 2019 have been revised upward by 104.2% and 11.5%, respectively, over the past 60 days.
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