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ZGNX

Zogenix

$12.35

-0.65 (-5.00%)

16:22
08/08/17
08/08
16:22
08/08/17
16:22

Zogenix reports Q2 EPS (93c), consensus (89c)

Reports Q2 revenue $7.13M, consensus $3.48M. The company said,"We remain on target to announce Study 1 top-line results from our ZX008 Phase 3 program in Dravet syndrome late in the third quarter of this year. The completion of Study 1 will be a significant milestone for our company, as it will represent the culmination of over two years of effort at Zogenix. Importantly, these will be the first results from one of our placebo-controlled, clinical trial evaluating the potential of low-dose fenfluramine as a safe and effective treatment for Dravet syndrome. In addition, our second planned pivotal Phase 3 data readout for Dravet syndrome, Study 1504, has enrolled approximately two-thirds of the targeted number of subjects. We are focused on completing enrollment in Study 1504 by the end of the current quarter."

  • 08

    Aug

ZGNX Zogenix
$12.35

-0.65 (-5.00%)

10/04/16
LEER
10/04/16
INITIATION
Target $17
LEER
Outperform
Zogenix reinstated with an Outperform at Leerink
Leerink analyst Paul Matteis resumed coverage of Zogenix with an Outperform rating and $17 price target.
11/11/16
AGIS
11/11/16
INITIATION
Target $28
AGIS
Buy
Zogenix initiated with a Buy at Aegis
Target $28.
12/05/16
12/05/16
NO CHANGE

Zogenix announces new data for ZX008
Zogenix announced new data demonstrating effectiveness and cardiovascular-related safety for patients treated with ZX008 as an adjunctive therapy for seizures associated with Lennox Gastaut Syndrome, or LGS, and continued effectiveness and safety for the on-going open-label patients with Dravet syndrome. The data were presented at the 70th Annual American Epilepsy Society meeting, taking place this week in Houston, Texas. The LGS data presented were from an interim analysis of the first 13 patients to have completed at least 12 weeks of a Phase 2 open-label, dose-finding investigator-initiated study, led by Lieven Lagae, M.D., Ph.D., Professor at the University of Leuven, Belgium, Head of the Pediatric Neurology Department and Director of the Childhood Epilepsy Program at the University of Leuven Hospitals. Patients enrolled in the study were 3-18 years of age diagnosed with LGS with at least four convulsive seizures and on at least two anti-epileptic drugs, or AEDs, at stable doses in the four weeks prior to study initiation. Participants were treated with ZX008 as an add-on therapy for up to 20 weeks starting at 0.2mg/kg/day. The dose could be titrated at four-week intervals based on treatment response up to a maximum of 0.8 mg/kg/day if the patient did not reach at least a 50% reduction in major motor seizure frequency. It is important to note that, per protocol, dose escalation stopped when a patient's major motor seizure frequency was reduced by greater than or equal to 50% of baseline. The mean age of participants was 11.4 years and they had failed a median of five antiepileptic therapies prior to this study. At study initiation, patients were receiving a median of four antiepileptic therapies. The median number of major motor seizures during the four-week baseline period was 60. In the Intent-to-Treat, or ITT, patient population, there was a median 50% reduction in seizure frequency over the entire treatment period compared to baseline, with seven patients to date achieving a greater than or equal to 50% reduction in the number of major motor seizures in this step dose study.

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