This morning, Zogenix, Inc. (NASDAQ:ZGNX) investors feel like they won the lottery. Why? Zogenix shares skyrocketed nearly 150% after the drug maker announced positive top-line results from its first Phase 3 trial (Study 1) for its investigational drug, ZX008, for the treatment of Dravet syndrome.
Fortunately, the trial met its primary objective of demonstrating that ZX008 is superior to placebo as adjunctive therapy in the treatment of Dravet syndrome in children and young adults based on change in the frequency of convulsive seizures between the 6-week baseline observation period and the 14-week treatment period. ZX008 also demonstrated statistically significant improvements versus placebo in all key secondary measures, including the proportion of patients with clinically meaningful reductions in seizure frequency and longest seizure-free interval.
ZX008 is designated as an orphan drug in both the U.S. and Europe, and has received Fast Track designation in the U.S. for the treatment of Dravet syndrome.
Zogenix CEO Stephen J. Farr stated, “On behalf of everyone at Zogenix, I would like to extend my sincere appreciation to the patients, families and investigators involved in this study. We are extremely pleased with the top-line efficacy and safety results from Study 1 which reinforce the potential of ZX008 to be an important new treatment for seizure control in children with Dravet syndrome. We look forward to presenting further data in future publications and at medical conferences […] We expect top-line results from our second pivotal Phase 3 trial, Study 1504, which is nearing full enrollment, in the first half of 2018. We remain on track to submit applications for regulatory approvals in the U.S. and Europe in the second half of 2018.”
Joseph Sullivan, Principal Investigator of Study 1 in the US, commented, “Dravet syndrome is a rare, but catastrophic form of epilepsy that can be devastating for patients and their families […] These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of low-dose fenfluramine for patients with Dravet syndrome. If approved, ZX008 could play an important role in treating this devastating condition.”
On the ratings front, ZGNX stock has been the subject of a number of recent research reports. In a report issued on September 21, Stifel analyst Annabel Samimy reiterated a Buy rating on ZGNX, with a price target of $26, which implies an upside of 102% from current levels. On September 6, Mizuho’s Difei Yang assigned a Buy rating to the stock and has a price target of $28.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Annabel Samimy and Difei Yang have a yearly average return of 7.5% and 10.8% respectively. Samimy has a success rate of 46% and is ranked #863 out of 4669 analysts, while Yang has a success rate of 51% and is ranked #385.
Zogenix is a pharmaceutical company, which engages in the development and commercialization of central nervous system (CNS) therapies and products for the treatment orphan diseases and other CNS disorders. It develops two products candidate: ZX008 and Relday.