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October 25, 2013
14:32 EDTZGNXZogenix surges after FDA approves pain management drug
Shares of Zogenix (ZGNX) are jumping after the company announced that the FDA had approved its pain management drug. WHAT'S NEW: The FDA announced intraday that it approved Zogenix's pain management drug, Zohydro. The agency approved the drug for use by patients who have pain severe enough to require daily, around-the-clock, long-term treatment and who cannot be adequately comforted with other treatment options, the company stated. WHAT'S NOTABLE: In a note to investors on September 27, William Blair analyst Tim Lugo wrote that his price target for Zogenix would have been about $6 if the FDA was to approve Zohydro. According to Lugo, Zogenix had several upcoming catalysts other than Zohydro that could enable the stock to outperform through September 2014. He kept an Outperform rating on the shares. TODAY'S PRICE ACTION: In mid-afternoon trading, Zogenix surged 93c, or 40%, to $3.15.
News For ZGNX From The Last 14 Days
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October 5, 2015
16:28 EDTZGNXGreat Point raises passive stake in Zogenix to 5.93%
September 30, 2015
08:07 EDTZGNXZogenix reports positive top-line results from Relday Phase 1b clinical trial
Zogenix announced positive top-line pharmacokinetic results from its Phase 1b multi-dose clinical trial of Relday, a proprietary, once-monthly subcutaneous investigational formulation of risperidone for the treatment of schizophrenia. If approved, Relday has the potential to be the first subcutaneous antipsychotic product that achieves therapeutic drug levels on the first day of administration, allows for once-monthly dosing and does not require reconstitution. Zogenix has retained Locust Walk Partners of Cambridge, MA, a transaction advisory firm for life sciences companies, to provide transaction advisory and support services for Relday, and has now initiated efforts to secure a global strategic development and commercialization partner for Relday. The Phase 1b multi-dose parallel group clinical trial enrolled 60 subjects comprised of three cohorts of patients receiving four monthly injections of Relday, at dose levels of either 60, 90 or 120 mg of risperidone per month. A fourth cohort received five bi-weekly intramuscular injections of Risperdal Consta. Risperdal Consta requires oral supplementation for the first three weeks following dosing initiation, and requires at least four doses to reach steady state. The results for Relday demonstrated that risperidone plasma concentrations in the therapeutic range were achieved on the first day of dosing, reached steady state levels following the second dose and consistently maintained therapeutic levels throughout the four-month period. In addition, dose proportionality was confirmed across the dose range intended for clinical practice (60 to 120 mg). Relday was generally safe and well-tolerated, with results consistent with the profile of risperidone and the Company's previous Phase 1 single-dose clinical trial.

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