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Zogenix Inc (ZGNX.OQ)

ZGNX.OQ on NASDAQ Stock Exchange Global Market

39.02USD
22 May 2019
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Latest Key Developments (Source: Significant Developments)

Zogenix Reports Q1 Loss Per Share $0.83
Thursday, 9 May 2019 

May 8 (Reuters) - Zogenix Inc ::ZOGENIX PROVIDES CORPORATE UPDATE AND REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS.Q1 LOSS PER SHARE $0.83.Q1 EARNINGS PER SHARE ESTIMATE $-0.83 -- REFINITIV IBES DATA.TYPE A MEETING WITH U.S. FDA EXPECTED BY EARLY JUNE TO DISCUSS FINTEPLA® DRAVET SYNDROME NDA EXPECTED BY EARLY JUNE.AS OF MARCH 31, 2019, COMPANY HAD $480.7 MILLION IN CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES.  Full Article

Zogenix Receives Refusal To File Letter From U.S. FDA For Fintepla New Drug Application
Tuesday, 9 Apr 2019 

April 8 (Reuters) - Zogenix Inc ::ZOGENIX RECEIVES REFUSAL TO FILE LETTER FROM U.S. FOOD AND DRUG ADMINISTRATION FOR FINTEPLA® NEW DRUG APPLICATION.ZOGENIX - UPON PRELIMINARY REVIEW, FDA DETERMINED FINTEPLA NDA, SUBMITTED ON FEB 5 WAS NOT SUFFICIENTLY COMPLETE TO PERMIT A SUBSTANTIVE REVIEW.ZOGENIX - WILL SEEK IMMEDIATE GUIDANCE, INCLUDING A TYPE A MEETING WITH FDA, TO CLARIFY, RESPOND TO ISSUES IDENTIFIED IN FINTEPLA NDA RTF LETTER.ZOGENIX - IN FINTEPLA RTF LETTER, FDA SAID SOME NON-CLINICAL STUDIES WERE NOT SUBMITTED TO ALLOW ASSESSMENT OF CHRONIC ADMINISTRATION OF FENFLURAMINE.ZOGENIX - IN FINTEPLA RTF LETTER, FDA SAID APPLICATION CONTAINED AN INCORRECT VERSION OF A CLINICAL DATASET.ZOGENIX INC - FDA HAS NOT REQUESTED OR RECOMMENDED ADDITIONAL CLINICAL EFFICACY OR SAFETY STUDIES FOR FINTEPLA.  Full Article

Zogenix Enters Exclusive Distribution Agreement With Nippon Shinyaku For Fintepla® In Japan
Tuesday, 19 Mar 2019 

March 19 (Reuters) - Zogenix Inc ::ZOGENIX ENTERS EXCLUSIVE DISTRIBUTION AGREEMENT WITH NIPPON SHINYAKU FOR FINTEPLA® IN JAPAN.ZOGENIX INC - NIPPON SHINYAKU WILL RECEIVE EXCLUSIVE COMMERCIAL RIGHTS TO FINTEPLA IN JAPAN..ZOGENIX INC - ZOGENIX WILL RECEIVE PAYMENTS TOTALING $20 MILLION FROM DEAL.ZOGENIX INC - ZOGENIX WILL ALSO BE ELIGIBLE TO RECEIVE FUTURE REGULATORY AND SALES-BASED MILESTONE PAYMENTS..ZOGENIX - TO SUPPLY PRODUCT TO NIPPON SHINYAKU, RECEIVE TIERED TRANSFER PRICE BASED ON MANUFACTURING COSTS, ANNUAL NET SALES OF FINTEPLA IN JAPAN.ZOGENIX INC - ZOGENIX WILL RETAIN RESPONSIBILITY FOR COMPLETING ITS GLOBAL CLINICAL DEVELOPMENT PROGRAMS FOR FINTEPLA.  Full Article

Zogenix Provides Corporate Update And Reports Fourth Quarter And Full-Year 2018 Financial Results
Friday, 1 Mar 2019 

Feb 28 (Reuters) - Zogenix Inc ::ZOGENIX PROVIDES CORPORATE UPDATE AND REPORTS FOURTH QUARTER AND FULL-YEAR 2018 FINANCIAL RESULTS.Q4 LOSS PER SHARE $0.53.Q4 EARNINGS PER SHARE ESTIMATE $-1.02 -- REFINITIV IBES DATA.ZOGENIX - AS OF DECEMBER 31, 2018, CO HAD $514.2 MILLION IN CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES, COMPARED TO $293.5 MILLION AT DECEMBER 31, 2017..  Full Article

Zogenix announces positive phase 3 trial results on the efficacy and safety of Fintepla (Zx008) in dravet syndrome
Monday, 3 Dec 2018 

Dec 3 (Reuters) - Zogenix Inc ::ZOGENIX ANNOUNCES POSITIVE PHASE 3 TRIAL RESULTS ON THE EFFICACY AND SAFETY OF FINTEPLA® (ZX008) IN DRAVET SYNDROME.ZOGENIX INC - CLINICALLY MEANINGFUL REDUCTION IN CONVULSIVE SEIZURE FREQUENCY FOR FINTEPLA MAINTAINED OVER PHASE 3 OPEN-LABEL EXTENSION TRIAL.ZOGENIX INC - STUDY 1504 MET PRIMARY ENDPOINT AND ALL KEY SECONDARY ENDPOINTS.ZOGENIX INC - RESULTS DEMONSTRATED STATISTICALLY SIGNIFICANT EFFICACY OF FINTEPLA.ZOGENIX INC - STUDY ALSO DEMONSTRATED STATISTICALLY SIGNIFICANT DIFFERENCES IN SEIZURE-FREE INTERVALS.ZOGENIX INC - INCIDENCE OF SERIOUS ADVERSE EVENTS WAS SIMILAR IN BOTH TREATMENT AND PLACEBO GROUPS.ZOGENIX - MOST COMMON ADVERSE EVENTS IN FINTEPLA GROUP WERE DECREASED APPETITE (44%), PYREXIA (26%), FATIGUE (26%), DIARRHEA (23%), NASOPHARYNGITIS (16%).ZOGENIX INC - ACROSS ALL TRIALS, NO SAFETY SIGNAL OF ANY VALVULAR HEART DISEASE HAS BEEN IDENTIFIED TO DATE.  Full Article

Zogenix Q3 Loss Per Share $1.08
Friday, 9 Nov 2018 

Zogenix Inc ::ZOGENIX PROVIDES CORPORATE UPDATE AND REPORTS THIRD QUARTER FINANCIAL RESULTS.Q3 LOSS PER SHARE $1.08.Q3 EARNINGS PER SHARE VIEW $-0.88 -- THOMSON REUTERS I/B/E/S.  Full Article

Zogenix Announces Positive Top-Line Results From Second Pivotal Phase 3 Clinical Trial Of Zx008 In Dravet Syndrome
Thursday, 12 Jul 2018 

July 12 (Reuters) - Zogenix Inc ::ZOGENIX ANNOUNCES POSITIVE TOP-LINE RESULTS FROM SECOND PIVOTAL PHASE 3 CLINICAL TRIAL OF ZX008 IN DRAVET SYNDROME.ZOGENIX INC - ZX008 ALSO DEMONSTRATED STATISTICAL SIGNIFICANCE IN ALL KEY SECONDARY ENDPOINTS.ZOGENIX INC - U.S. AND EU REGULATORY SUBMISSIONS ON TRACK FOR Q4 OF 2018.ZOGENIX - PRIMARY ENDPOINT ACHIEVED - STATISTICALLY SIGNIFICANT CONVULSIVE SEIZURE REDUCTION FOR ZX008 VERSUS PLACEBO FOR ADJUNCTIVE TREATMENT OF SEIZURES.ZOGENIX INC - ZX008 ALSO DEMONSTRATED STATISTICALLY SIGNIFICANT IMPROVEMENT VERSUS PLACEBO IN BOTH KEY SECONDARY MEASURES.ZOGENIX - ZX008 GENERALLY WELL-TOLERATED IN STUDY WITH ADVERSE EVENTS CONSISTENT WITH THOSE OBSERVED IN STUDY 1 & KNOWN SAFETY PROFILE OF FENFLURAMINE.  Full Article

Zogenix Says Repaid Entire $20.1 Mln Of Outstanding Principal & Interest Under Its Loan And Security Agreement
Saturday, 30 Dec 2017 

Dec 29 (Reuters) - Zogenix Inc ::ZOGENIX SAYS REPAID IN FULL ENTIRE $20.1 MILLION OF OUTSTANDING PRINCIPAL & INTEREST UNDER ITS LOAN AND SECURITY AGREEMENT DATED AS OF DEC 30, 2014.ZOGENIX SAYS IN CONNECTION WITH REPAYMENT, CO WAS ALSO REQUIRED TO MAKE FINAL PAYMENT OF ABOUT $1.4 MILLION, OTHER PAYMENTS - SEC FILING.  Full Article

Zogenix Announces New Data From Pivotal Phase 3 Clinical Trial Of ZX008
Monday, 4 Dec 2017 

Dec 4 (Reuters) - Zogenix Inc ::ZOGENIX ANNOUNCES NEW POSITIVE EFFICACY AND SAFETY DATA FROM PIVOTAL PHASE 3 CLINICAL TRIAL OF ZX008 IN DRAVET SYNDROME.ZOGENIX INC - DATA SHOWS ZX008 PATIENTS MORE LIKELY TO ACHIEVE CLINICALLY MEANINGFUL REDUCTION IN SEIZURE FREQUENCY COMPARED TO THOSE ON PLACEBO.ZOGENIX INC - LOOK FORWARD TO SHARING TOP-LINE RESULTS FROM SECOND PIVOTAL PHASE 3 TRIAL OF ZX008, STUDY 1504, IN Q2 OF 2018.  Full Article

Zogenix Announces Initiation Of Phase 3 Trial For ZX008 In Lennox-Gastaut Syndrome
Wednesday, 29 Nov 2017 

Nov 29 (Reuters) - Zogenix Inc ::ZOGENIX ANNOUNCES INITIATION OF PHASE 3 TRIAL FOR ZX008 IN LENNOX-GASTAUT SYNDROME.  Full Article

Zogenix's seizure drug filing fails to pass U.S. FDA scrutiny

The U.S. Food and Drug Administration on Monday refused to fully review the marketing application for Zogenix Inc's treatment for seizures associated with Dravet syndrome, a rare form of childhood epilepsy.