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AstraZeneca PLC (AZN.N)

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Latest Key Developments (Source: Significant Developments)

Astrazeneca's Imfinzi Granted U.S. Orphan Drug Designation For Small Cell Lung Cancer
Friday, 12 Jul 2019 

July 12 (Reuters) - AstraZeneca PLC ::ASTRAZENECA PLC - IMFINZI GRANTED US ORPHAN DRUG DESIGNATION FOR.ASTRAZENECA PLC - IMFINZI GRANTED US ORPHAN DRUG DESIGNATION FOR SMALL CELL LUNG CANCER.ASTRAZENECA PLC - IMFINZI GRANTED US ORPHAN DRUG DESIGNATION FOR SMALL CELL LUNG CANCER.  Full Article

Foundation Medicine Says Got FDA Approval For Foundationone CDX As Companion Diagnostic For Lynparza
Tuesday, 2 Jul 2019 

July 1 (Reuters) - Foundation Medicine::FOUNDATION MEDICINE - GOT FDA APPROVAL FOR FOUNDATIONONE CDX AS COMPANION DIAGNOSTIC FOR LYNPARZA FOR BRCA-MUTATED ADVANCED OVARIAN CANCER THERAPY.  Full Article

AstraZeneca Says Forxiga Receives Positive EU CHMP Opinion For DECLARE-TIMI 58 Cardiovascular Outcomes Data
Monday, 1 Jul 2019 

July 1 (Reuters) - AstraZeneca PLC ::FORXIGA RECEIVES POSITIVE EU CHMP OPINION FOR.FORXIGA RECEIVES POSITIVE EU CHMP OPINION FOR DECLARE-TIMI 58 CARDIOVASCULAR OUTCOMES DATA.CHMP RECOMMENDED CHANGE TO EUROPEAN MARKETING AUTHORISATION FOR FORXIGA IN PATIENTS WITH (T2D) TO INCLUDE CARDIOVASCULAR OUTCOMES DATA.REGULATORY REVIEWS AND SUBMISSIONS ARE ONGOING IN SEVERAL COUNTRIES, INCLUDING US, CHINA AND JAPAN.  Full Article

Astrazeneca Says Fasenra Receives Positive EU CHMP Opinion For Self-Administration And New Fasenra Pen
Monday, 1 Jul 2019 

July 1 (Reuters) - AstraZeneca PLC ::FASENRA RECEIVES POSITIVE EU CHMP OPINION FOR SELF.FASENRA RECEIVES POSITIVE EU CHMP OPINION FOR SELF-ADMINISTRATION AND NEW FASENRA PEN, A PRE-FILLED, SINGLE-USE AUTO-INJECTOR.CHMP OPINION CAN BE IMPLEMENTED WITHOUT NEED FOR A EUROPEAN COMMISSION DECISION DUE TO NATURE OF TYPE-II LABEL VARIATION.POSITIVE OPINION FOR SELF-ADMINISTRATION, FASENRA PEN IS SUPPORTED BY PHASE III GREGALE AND GRECO TRIALS, PHASE I AMES TRIAL.ANTICIPATES REGULATORY DECISION BY FDA ON SELF-ADMINISTRATION, NEW PRE-FILLED, SINGLE-USE AUTO-INJECTOR DEVICE IN SECOND HALF OF 2019.  Full Article

Astrazeneca Says Lynparza Approved In EU For 1st-Line Maintenance Treatment Of A Type Of Ovarian Cancer
Tuesday, 18 Jun 2019 

June 18 (Reuters) - AstraZeneca PLC ::LYNPARZA APPROVED IN EU FOR 1ST-LINE MAINTENANCE TREATMENT OF BRCA-MUTATED ADVANCED OVARIAN CANCER.EUROPEAN COMMISSION APPROVED LYNPARZA (OLAPARIB) AS A 1ST-LINE MAINTENANCE TREATMENT FOR WOMEN WITH BRCA-MUTATED ADVANCED OVARIAN CANCER.  Full Article

Astrazeneca Says Lokelma Presented Positive Results From Phase IIIb Dialize Trial
Friday, 14 Jun 2019 

June 14 (Reuters) - AstraZeneca PLC ::ASTRAZENECA PLC - LOKELMA DEMONSTRATED EFFICACY IN TREATING HYPERKALAEMIA IN PATIENTS WITH ENDSTAGE RENAL DISEASE ON HAEMODIALYSIS.ASTRAZENECA - IN PHASE IIIB DIALIZE TRIAL, 41.2% OF LOKELMA PATIENTS MAINTAINED NORMAL POTASSIUM LEVELS PRE-DIALYSIS VERSUS 1% RECEIVING PLACEBO.ASTRAZENECA PLC - SAFETY PROFILE OF LOKELMA OBSERVED IN DIALIZE WAS CONSISTENT WITH PREVIOUS TRIALS.ASTRAZENECA - PRESENTED POSITIVE RESULTS FROM PHASE IIIB DIALIZE TRIAL.  Full Article

Astrazeneca Plots Search For Next Chairman - Sky News
Monday, 3 Jun 2019 

June 3 (Reuters) - :ASTRAZENECA PLOTS SEARCH FOR NEXT CHAIRMAN - SKY NEWS.ASTRAZENECA BOARD IS AT EARLY STAGES OF PLANNING TO SEEK EVENTUAL REPLACEMENT FOR LEIF JOHANSSON, WHO HAS CHAIRED CO FOR 7 YEARS- SKY NEWS.  Full Article

Astrazeneca PLC Says Pooled Analyses Of The Roxadustat Global Phase III Programme Confirmed Cardiovascular Safety
Friday, 10 May 2019 

May 9 (Reuters) - AstraZeneca PLC ::SAYS ANNOUNCED TOP-LINE RESULTS FROM THE POOLED CARDIOVASCULAR (CV) SAFETY ANALYSES OF THE GLOBAL PHASE III PROGRAMME FOR ROXADUSTAT.POOLED ANALYSES OF THE ROXADUSTAT GLOBAL PHASE III PROGRAMME CONFIRMED CARDIOVASCULAR SAFETY.ROXADUSTAT HAD BETTER OUTCOME VERSUS. EPOETIN ALFA IN INCIDENT-DIALYSIS PATIENTS AND COMPARABLE TO PLACEBO IN PATIENTS NOT ON DIALYSIS.  Full Article

Astrazeneca Says Lynparza Approved In EU For Treatment Of Germl
Wednesday, 10 Apr 2019 

April 10 (Reuters) - AstraZeneca PLC ::LYNPARZA APPROVED IN EU FOR THE TREATMENT OF GERML.LYNPARZA APPROVED IN EU FOR TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE ADVANCED BREAST CANCER.  Full Article

Selumetinib Granted U.S. Breakthrough Therapy Designation In Neurofibromatosis Type 1
Monday, 1 Apr 2019 

April 1 (Reuters) - Merck & Co Inc ::SELUMETINIB GRANTED U.S. BREAKTHROUGH THERAPY DESIGNATION IN NEUROFIBROMATOSIS TYPE 1.MERCK & CO INC - DESIGNATION BASED ON PHASE 2 SPRINT TRIAL IN PEDIATRIC PATIENTS WITH NF1 PLEXIFORM NEUROFIBROMAS.MERCK & CO INC - SELUMETINIB IS A MEK 1/2 INHIBITOR BEING CO-DEVELOPED BY ASTRAZENECA AND MERCK.  Full Article

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AstraZeneca's Farxiga fails to get U.S. approval for Type-1 diabetes

British drugmaker AstraZeneca Plc said on Monday the U.S. Food and Drug Administration declined to approve its diabetes treatment, Farxiga, for use as a supplement to insulin in adults with a rare-type of the condition.