Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  News  >  Companies  >  All News

News : Companies

Latest NewsCompaniesMarketsEconomy & ForexCommoditiesInterest RatesBusiness LeadersFinance ProfessionalsCalendarSectors

Zogenix Inc. : Trading of Zogenix Common Stock Halted

share with twitter share with LinkedIn share with facebook
share via e-mail
0
12/07/2012 | 02:00pm CET

FDA Advisory Committee Reviewing Zohydro™ ER New Drug Application

Zogenix to Host Conference Call at 6:30 pm ET Today

SAN DIEGO, Dec. 7, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced that NASDAQ halted trading of the company's common stock on December 7, 2012. The U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) is meeting today to review the Company's New Drug Application (NDA) for Zohydro™ ER (hydrocodone bitartrate extended-release capsules).

Conference Call & Webcast

Zogenix will host a conference call to discuss the outcome of the AADPAC meeting today, Friday, December 7, 2012 at 6:30 p.m. ET (3:30 p.m. PT). To participate, please dial (800) 299-9086 (U.S.) or (617) 786-2903 (International); participant passcode: 21970283. To access the live webcast please visit the Zogenix Investor Relations website at http://ir.zogenix.com.  

The conference call will be hosted by Chief Executive Officer Roger L. Hawley and President and Chief Operating Officer Stephen J. Farr, Ph.D.

A replay of the conference call will be available beginning December 7, 2012 at 8:30 p.m. ET (5:30 p.m. PT) until December 14, 2012, by dialing (888) 286-8010 (U.S.) or (617) 801-6888 (International); passcode: 27116437. A replay of the webcast will also be accessible on the Investor Relations website for one month, through January 10, 2013.

About Anesthetic and Analgesic Drug Products Advisory Committee

The AADPAC reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human anesthetic and analgesic drug products and makes appropriate recommendations to the Commissioner of Food and Drugs. The AADPAC provides FDA with independent expert advice and recommendations, however, the final decision regarding approval is made by FDA.

About Zogenix

Zogenix, Inc., with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, ZohydroTM ER (hydrocodone bitartrate) is an oral, novel extended-release formulation of various strengths of hydrocodone without acetaminophen intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. Zogenix's second DosePro investigational product candidate, ReldayTM, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia. In May 2012, Zogenix submitted to the FDA a New Drug Application for Zohydro ER and an Investigational New Drug Application for Relday. The FDA assigned a PDUFA target action date of March 1, 2013 for the Zohydro ER NDA.

For additional information, please visit www.zogenix.com.

SUMAVEL ®, DosePro ®, ReldayTM and ZohydroTM ER are trademarks of Zogenix, Inc.

CONTACT: INVESTORS:
         Zack Kubow | The Ruth Group
         646.536.7020 | [email protected]

         MEDIA:
         Emily Poe | WCG
         212.301.7183 | [email protected]
Zogenix
distributed by
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news "Companies"
11:29p AMAYSIM AUSTRALIA : 2018 first half financial year results - investor briefing
11:29p CEL SCI : NEW STORY CEL-SCI Announces Robert Watson Joins Its Board of Directors
11:29p MUSGRAVE MINERALS : Veritas Research Report
11:29p NGE CAPITAL : Daily share buy-back notice Appendix 3E - 19Dec17
11:29p ANZ AUSTRALIA & NEW ZEALAND BANKING : International payments now on ANZ goMoney for Android (PDF 32kB)
11:29p ORIOLA OYJ : Robert Andersson appointed Oriola Corporation´s new President and CEO
11:29p SNYDER'S-LANCE, INC. : Other Events, Financial Statements and Exhibits (form 8-K)
11:29p FIRST NATIONAL FINANCIAL : Partners Announces $32.3 Million in Mortgage Financings at Two Properties and Notice of Final Redemption of Its Series III Debentures on January 17, 2018
11:28p AMTECH SYSTEMS INC : Other Events (form 8-K)
11:28p CAESARS ENTERTAINMENT CORP : Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits (form 8-K)
Latest news "Companies"
Advertisement