Zogenix Provides Corporate Update And Reports Third Quarter 2016 Financial Results

EMERYVILLE, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of orphan and central nervous system (CNS) disorders, today provided a corporate update and announced financial results for the third quarter ended September 30, 2016.

  • Continued enrollment in the two Phase 3 safety and efficacy clinical trials of ZX008 (low-dose fenfluramine) (Studies 1501 and 1502) in North America, Europe and Australia, with top-line results anticipated in Q2 2017. 
  • Company remains on-track for potential regulatory submissions by year-end 2017. 
  • Initiated Cohort 1 (pharmacokinetic assessment) in Study 1504, a trial evaluating the pharmacokinetics, efficacy and safety of ZX008 in patients who have responded poorly to a stiripentol regimen. Cohort 2 (efficacy and safety assessment) is expected to begin by the end of this year. 
  • Effectiveness and safety results of ZX008 from the ongoing open-label prospective study of patients with Dravet syndrome published in the European Journal of Neurology.  The study demonstrated a robust median reduction in seizures of 75% (range, 28-100%) during the treatment period with no cardiovascular abnormalities. Schoonjans, A. S., Paelinck, B. P., Marchau, F., Gunning, B., Gammaitoni, A., Galer, B. S., Lagae, L. and Ceulemans, B. (2016). Eur J Neurol. doi:10.1111/ene.13195 
  • Presented further data at the 12 th European Congress on Epileptology related to understanding the burden Dravet syndrome causes for the patient and their family, and also on identifying clinically relevant outcome measures to assess the quality of life impact on Dravet syndrome patients and their caregivers. 
  • Multiple abstracts accepted for presentation at the upcoming American Epilepsy Society Annual Meeting (December 2-6, 2016) highlighting new clinical and pre-clinical findings, including an interim analysis of an on-going investigator initiated open-label Phase 2 trial in Lennox Gastaut syndrome.  
  • Completed the nine-months ended September 30, 2016, with $109.9 million in cash and cash equivalents. Zogenix expects its cash runway to extend through 2017.

"During the third quarter, we continued to accelerate the clinical development of our lead product, ZX008 for Dravet syndrome," said Stephen J. Farr, Ph.D., President and CEO. "We are continuing to enroll patients in both Phase 3 trials and intend to report top-line data in the second quarter of 2017.  We look forward to having a significant presence, including the presentation of multiple posters and hosting a Scientific Exhibit Room, at the upcoming American Epilepsy Society Meeting in December."

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