Imfinzi approved in China for the treatment of unresectable, Stage III non-small cell lung cancer based on the Phase III PACIFIC trial. Imfinzi is the only immunotherapy approved in China to treat patients in the curative-intent Stage III setting following chemoradiation treatment. Dave Fredrickson, Executive Vice President, Oncology Business Unit said: "...
RNS Number: 5491 W AstraZeneca PLC 11 December 2019 11 December 2019 13:00 GMT. Trastuzumab deruxtecan achieved a tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial. AstraZeneca and Daiichi Sankyo's trastuzumab deruxtecan demonstrated an impressive 14.8- month median duration of response and 16.4- month...
[Fam]-Trastuzumab Deruxtecan Achieved a Tumor Response of 60.9% in Pivotal Phase II HER2-positive Metastatic Breast Cancer Trial
AstraZeneca and Daiichi Sankyo Company, Limited today presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of- trastuzumab deruxtecan, an investigational HER2-targeting antibody drug conjugate and potential new medicine, in patients with HER2-positive metastatic breast cancer who received two or more...
CALQUENCE Significantly Prolonged the Time Patients Lived Without Disease Progression or Death in Previously Untreated Chronic Lymphocytic Leukemia
AstraZeneca today presented results from the interim analysis of the Phase III ELEVATE TN trial, showing that CALQUENCE ® combined with obinutuzumab or as monotherapy significantly improved progression-free survival compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated...
Lynparza approved in China as a 1st- line maintenance therapy in BRCA-mutated advanced ovarian cancer. Only PARP inhibitor approved in this setting in China. The approval in China is based on the results from the Phase III SOLO-1 trial, which were published in The New England Journal of Medicine. Results showed that Lynparza significantly reduced the risk of...
AstraZeneca divests rights to Seroquel and Seroquel XR in the US and Canada. AstraZeneca has agreed to sell the commercial rights to Seroquel and Seroquel XR in the US and Canada to Cheplapharm Arzneimittel GmbH. Seroquel and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in the US and...
The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6. 1. As at 30 November 2019 the issued share capital of AstraZeneca PLC with voting rights is 1,311,913,268 ordinary shares of US $0.25. The above figure for the total number of voting rights may be used by shareholders as the...
The sBLA was based on positive results from the Phase III CASPIAN trial published in The Lancet, s howing Imfinzi in combination with standard-of-care chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival vs. Imfinzi is approved in the curative-intent setting of unresectable, Stage III...
CALQUENCE Approved in the US for Adult Patients With Chronic Lymphocytic Leukemia
AstraZeneca today announced that the US Food and Drug Administration has approved CALQUENCE ® for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The US approval was granted under the FDA’ s Real-Time Oncology Review and newly established Project Orbis programs. The approval is based on positive results from the interim...
RNS Number: 2853 U AstraZeneca PLC 21 November 2019 21 November 2019 18:10 GMT. Calquence approved in the US for adult patients with chronic lymphocytic leukaemia. Two Phase III Calquence trials demonstrated superior progression-free survival across multiple settings while maintaining favourable tolerability.
Subgroup Analysis of TWILIGHT Trial Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Who Underwent PCI Showed BRILINTA Monotherapy Reduced the Risk of Clinically Relevant Bleeding Compared With Dual Antiplatelet Therapy (DAPT)
Roxana Mehran, TWILIGHT's Global Principal Investigator and Director of the Center for Interventional Cardiovascular Research and Clinical Trials at Mount Sinai Heart and Professor of Cardiology, and Population Health Science and Policy, at Icahn School of Medicine at Mount Sinai in New York, US, said:“ The finding that ticagrelor monotherapy was not...
Consistent Effects of FARXIGA in Heart Failure Patients With Reduced Ejection Fraction Shown in New Analyses From Landmark Phase III DAPA-HF Trial
AstraZeneca today announced new data from five additional analyses of the landmark Phase III DAPA-HF trial, which showed that FARXIGA reduced the risk of the primary composite outcome of worsening heart failure, defined as hospitalization or an urgent visit, or death from cardiovascular causes versus placebo, when added to standard of care.
RNS Number: 5476 T AstraZeneca PLC 15 November 2019 15 November 2019 07:00 GMT. Qtrilmet approved in the EU f or the treatment of type-2 diabetes. AstraZeneca today announced that the European Commission has approved Qtrilmet modified-release tablets to improve glycaemic control in adults with type-2 diabetes..
AstraZeneca today announced the launch of Diabetes Can Break Your Heart, a national movement with a goal to change the trajectory of heart failure in type 2 diabetes. The initiative is designed to raise awareness, create community action and spark dialogue between those with T2D and their healthcare providers to help reduce the risk of HF— one of the earliest...
RNS Number: 3486 T AstraZeneca PLC 14 November 2019 14 November 2019 07:00 GMT. US FDA accepts regulatory submission for selumetinib in neurofibromatosis type 1 and grants Priority Review. AstraZeneca and MSD Inc., Kenilworth, N.J., US today announced that the US Food and Drug Administration has accepted a New Drug Application and granted Priority Review for...
RNS Number: 0408 T AstraZeneca PLC 12 November 2019 12 November 2019 07:00 GMT. Anifrolumab demonstrated superiority across multiple efficacy endpoints. in patients with systemic lupus erythematosus in Phase III TULIP 2 trial.
RNS Number: 8848 S AstraZeneca PLC 11 November 2019 11 November 2019 07:00 GMT. Roxadustat Phase III programme pooled analyses showed positive efficacy and no increased cardiovascular risk in patients with anaemia from chronic kidney disease. The results were presented in an oral late-breaking abstract session at the American Society of Nephrology...
Roxadustat Phase III Program Pooled Analyses Showed Positive Efficacy and No Increased Cardiovascular Risk in Patients with Anemia from Chronic Kidney Disease Versus Comparators
AstraZeneca and FibroGen Inc. today presented pooled efficacy and cardiovascular safety analyses from the pivotal Phase III program assessing roxadustat for the treatment of patients with anemia from chronic kidney disease. The results were presented in an oral late-breaking abstract session at the American Society of Nephrology Kidney Week 2019 in...
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