REG - AstraZeneca PLC - AZN: H1 2016 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 3
28/07/2016 07:07
- Part 3: For the preceding part double click ID:nRSb4551Fb
Status
Combination therapy
ALPS II 2nd line Pancreatic ductal carcinoma durva + treme (single arm) FPD Q4 2015 Data expected H2 2017 Recruiting
- II 2nd line Unresectable liver cancer durvalumab vs tremelimumab vs durva + treme FPD Q1 2016 Recruiting
Data expected 2017
- II 2nd/3rd line Metastatic gastric cancer durvalumab vs tremelimumab vs durva + treme FPD Q2 2016 Recruiting
Data expected 2017
f) MEDI0562 (cancer)
During the period, AstraZeneca made a final selection of the OX40 agonist to take forward to mid- and late-stage
development. The fully-humanised OX40 monoclonal antibody, MEDI562 is advancing in Phase I as a monotherapy and in
combination with durvalumab or tremelimumab. Data compiled from the murine OX40 (MEDI6469) and fusion-protein OX40
(MEDI6383) programmes have informed and directed the ongoing development of MEDI0562.
Infection & Neuroscience
a) Zavicefta (serious infections)
On 28 June 2016, the EMA granted marketing authorisation to Zavicefta (ceftazidime and avibactam, previously known as CAZ
AVI) for a broad label of indications covering complicated intra-abdominal infections, complicated urinary tract infections
including pyelonephritis (infection of the kidney), and hospital-acquired pneumonia, including ventilator-associated
pneumonia. The approval also included using Zavicefta to treat infections caused by aerobic Gram-negative organisms in
adult patients who have limited treatment options, an indication which, to date, has not been awarded to any other novel
antibiotic medicine.
On 21 July 2016, the Company announced positive results from the Phase III REPROVE trial, which assessed the efficacy of
Zavicefta compared with meropenem in the treatment of adult patients with hospital-acquired pneumonia, including
ventilator-associated pneumonia. Zavicefta met the primary objective of statistical non-inferiority compared to meropenem
at the test of cure visit (day 21 from randomisation). The trial showed an adverse event profile consistent with current
knowledge of the safety profile of the medicines.
b) Pandemic Live Attenuated Influenza Vaccine (P/LAIV) (pandemic influenza)
On 1 April 2016, the Committee for Medicinal Products for Human Use of the EMA issued a positive opinion recommending the
conditional approval of P/LAIV. P/LAIV is indicated for the prevention of influenza in a pandemic setting in children and
adolescents. In the event that the World Health Organization declares a pandemic, a dossier can be submitted for conversion
to full approval, providing an expedient public-health tool to protect European children.
ASTRAZENECA DEVELOPMENT PIPELINE 30 JUNE 2016
AstraZeneca-sponsored or -directed studies
Phase III / Pivotal Phase II / Registration
New Molecular Entities (NMEs) and significant additional indications
Regulatory submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by
the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed
at this time.
† US and EU dates correspond to anticipated acceptance of the regulatory submission.
# Collaboration.
Respiratory & Autoimmunity
Zurampic#1(lesinurad) selective uric acid reabsorption inhibitor (URAT-1) chronic treatment of hyperuricemia in patients with gout Q4 2011 Approved Approved N/A N/A
CLEAR 1,2
CRYSTAL
Bevespi Aerosphere (PT003) LABA/LAMA COPD Q2 2013 Approved 2017 2017 2017
brodalumab#2AMAGINE-1,2,3 IL-17R mAb psoriasis Q3 2012 Accepted Accepted N/A N/A
benralizumab#CALIMA SIROCCO ZONDA BISE BORAGREGALE IL-5R mAb severe asthma Q4 2013 H2 2016 H2 2016 N/A N/A
benralizumab#TERRANOVA GALATHEA IL-5R mAb COPD Q3 2014 2018 2018 N/A N/A
PT010 LABA/LAMA/ICS COPD Q3 2015 2018 2018 2018 2019
tralokinumabSTRATOS 1,2TROPOSMESOS IL-13 mAb severe asthma Q3 2014 2018 2018 2018
anifrolumab# TULIP IFN-alphaR mAb systemic lupus erythematosus Q3 2015 2019(Fast Track) 2019 2019
Cardiovascular & Metabolic Diseases
Brilinta3 P2Y12 receptor antagonist arterial thrombosis Launched Launched Accepted Launched
Farxiga4 SGLT2 inhibitor type-2 diabetes Launched Launched Launched Accepted
Epanova# omega-3 carboxylic acids severe hypertrigly-ceridemia Approved 2018
ZS-9 (sodium zirconium cyclosilicate) potassium binder hyperkalaemia H2 2016 Accepted
roxadustat# OLYMPUS (US) ROCKIES (US) hypoxia-inducible factor prolyl hydroxylase inhibitor anaemia in CKD/ESRD Q3 2014 2018 N/A N/A H2 20165
Oncology
TagrissoAURA, AURA 2, (AURA17 Asia regional) EGFR tyrosine kinase inhibitor ≥2nd-line advanced EGFRm T790M NSCLC Q2 2014 Launched(Breakthrough Therapy, Priority Review, Orphan drug) Launched (Accelerated assessment) Approved H2 2016
TagrissoAURA 3 EGFR tyrosine kinase inhibitor ≥2nd-line advanced EGFRm T790M NSCLC Q3 2014 2017 2017 2017 2018
cediranibICON 6 VEGFR tyrosine kinase inhibitor PSR ovarian cancer Q2 2007 Accepted (Orphan drug)
acalabrutinib# (ACP-196) Bruton's tyrosine kinase (BTK) inhibitor B-cell blood cancers Q1 2015 H2 2016(Orphan drug)
selumetinib# MEK inhibitor 2nd-line KRASm NSCLC Q4 2013 2017 2017
SELECT-1
selumetinib# MEK inhibitor differentiated thyroid cancer Q3 2013 2018(Orphan drug)6 2018
ASTRA
moxetumomab pasudotox#PLAIT anti-CD22 recombinant hairy cell leukaemia Q2 2013 2017(Orphan drug) 2018
immunotoxin
durvalumab#PACIFIC PD-L1 mAb stage III NSCLC Q2 2014 2017 2020 2020
durvalumab# +tremelimumab PD-L1 mAb + CTLA-4 mAb 3rd-line NSCLC Q2 2015 2017 2017 2017
ARCTIC
durvalumab# + tremelimumabMYSTIC PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q3 2015 2017 2017 2017 2020
durvalumab# + tremelimumabNEPTUNE PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q4 2015 2019 2019 2019
durvalumab# PD-L1 mAb 2nd-line SCCHN (PD-L1 positive) Q1 2015 2017(Fast Track) 2019 2019
HAWK¶
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line SCCHN (PD-L1 negative) Q2 2015 2017 2019 2019
CONDOR¶
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 1st-line SCCHN Q4 2015 2018 2018 2018
KESTREL
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line SCCHN Q4 2015 2019 2019 2019
EAGLE
durvalumab# + tremelimumabALPS¶ PD-L1 mAb + CTLA-4 mAb metastatic pancreatic ductal carcinoma Q4 2015 2017 2017 2017
durvalumab# + tremelimumabDANUBE PD-L1 mAb + CTLA-4 mAb 1st-line bladder cancer Q4 2015 2018 2018 2018
Infection & Neuroscience
Zinforo# extended spectrum cephalosporin with affinity to penicillin-binding proteins pneumonia/skin infections N/A Launched N/A Submitted
Zavicefta# (CAZ AVI#) cephalosporin/ beta lactamase inhibitor hospital-acquired pneumonia/ ventilator-associated pneumonia Q2 2013 N/A Approved7 N/A 2017
Zavicefta# cephalosporin/beta lactamase inhibitor serious infections, complicated intra-abdominal infection, complicated urinary tract infection Q1 2012 N/A Approved7 N/A 2017
MEDI-550 pandemic influenza virus vaccine pandemic influenza prophylaxis N/A Approved8 N/A N/A
AZD3293#AMARANTH beta-secretase inhibitor Early Alzheimer's disease Q2 2016 2020 2020 2020
N/A
N/A
AZD3293#AMARANTH
beta-secretase inhibitor
Early Alzheimer's disease
Q2 2016
2020
2020
2020
¶ Registrational Phase IItrial
1 AstraZeneca announced it has granted Ironwood exclusive US rights (26 April 2016) and Grünenthal exclusive rights in
Europe and Latin America (2 June 2016)
2 AstraZeneca and Valeant agreed to terminate the licence for Valeant's right to develop and commercialise brodalumab in
Europe. AstraZeneca entered into an agreement with LEO Pharma for the exclusive licence to brodalumab in Europe (1
July 2016)
3 Brilinta in the US; Brilique in rest of world
4 Farxiga in the US; Forxiga in rest of world
5 Rolling NDA submission to be initiated in H2 2016
6 FDA granted Orphan Drug Designation 10 May 2016
7 EU approval received 24 June 2016
8 EU approval received 20 May 2016
Phases I and II
NMEs and significant additional indications
Respiratory & Autoimmunity
PT010 LABA/LAMA/ICS asthma II Q2 2014
tralokinumab#1 IL-13 mAb atopic dermatitis II Q1 2015
anifrolumab# IFN-alphaR mAb lupus nephritis II Q4 2015
anifrolumab# IFN-alphaR mAb systemic lupus erythematosus (subcutaneous) I Q4 2015
verinurad selective uric acid reabsorption inhibitor (URAT-1) chronic treatment of hyperuricemia in patients with gout II Q3 2013
abediterol LABA asthma/COPD II Q4 2007
AZD7594 inhaled SGRM asthma/COPD II Q3 2015
AZD7624 inhaled P38 inhibitor COPD II Q4 2014
AZD9412# inhaled interferon beta asthma/COPD II Q3 2015
mavrilimumab# GM-CSFR mAb rheumatoid arthritis II Q1 2010
inebilizumab# CD19 mAb neuromyelitis optica II Q1 2015(Orphan drug)
MEDI2070# IL-23 mAb Crohn's disease II Q1 2013
tezepelumab# TSLP mAb asthma / atopic dermatitis II Q2 2014
lesinurad + allopurinol FDC#2 selective uric acid reabsorption inhibitor (URAT-1)+xanthine oxidase inhibitor FDC chronic treatment of hyperuricemia in patients with gout I Q4 2015
AZD1419# TLR9 agonist Asthma I Q3 2013
AZD5634 inhaled ENaC cystic fibrosis I Q1 2016
AZD7986 DPP1 COPD I Q4 2014
AZD8871 MABA COPD I Q4 2015
AZD9567 oral SGRM rheumatoid arthritis I Q4 2015
MEDI0700# BAFF/B7RP1 bispecific mAb systemic lupus erythematosus I Q1 2016
MEDI4920 anti-CD40L-Tn3 fusion protein primary Sjögren's syndrome I Q2 2014
MEDI5872# B7RP1 mAb systemic lupus erythematosus I Q4 2008
MEDI9314 IL-4R mAb atopic dermatitis I Q1 2016
Cardiovascular & Metabolic Diseases
MEDI4166 PCSK9/GLP-1 mAb + peptide fusion diabetes / cardiovascular II Q1 2016
MEDI6012 LCAT ACS II Q4 2015
AZD4076 anti-miR103/107 oligonucleotide non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH) I Q4 2015
AZD5718 FLAP CAD I Q1 2016
MEDI0382 GLP-1/glucagon dual agonist diabetes / obesity I Q1 2015
MEDI8111 Rh-factor II trauma / bleeding I Q1 2014
Oncology
durvalumab# PD-L1 mAb bladder cancer II Q1 2016(Breakthrough Therapy)
durvalumab# PD-L1 mAb solid tumours II Q3 2014
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb gastric cancer II Q2 2015
durvalumab# + AZD5069 PD-L1 mAb + CXCR2 SCCHN II Q3 2015
durvalumab# + AZD9150# PD-L1 mAb + STAT3 inhibitor
durvalumab# PD-L1 mAb solid tumours I Q3 2014
durvalumab# + monalizumab PD-L1 mAb + NKG2a mAb solid tumours I Q1 2016
durvalumab# + MEDI9447 PD-L1 mAb + CD73 mAb solid tumours I Q1 2016
durvalumab#+ Iressa PD-L1 mAb+ EGFR tyrosine kinase inhibitor NSCLC I Q2 2014
durvalumab# + MEDI0680 PD-L1 mAb + PD-1 mAb solid tumours I Q2 2014
durvalumab# + dabrafenib + trametinib PD-L1 mAb+ BRAF inhibitor + MEK inhibitor melanoma I Q1 2014
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb solid tumours I Q4 2013
Tagrisso + (durvalumab# or selumetinib# or savolitinib#)TATTON EGFR tyrosine kinase inhibitor + (PD-L1 mAb or MEK inhibitor or MET tyrosine kinase inhibitor) advanced EGFRm NSCLC II Q2 2016
selumetinib + durvalumab# MEK inhibitor + PD-L1 mAb solid tumours I Q4 2015
savolitinib/volitinib# MET tyrosine kinase inhibitor papillary renal cell carcinoma II Q2 2014
AZD1775#+ chemotherapy Wee1 inhibitor + chemotherapy ovarian cancer II Q4 2012
AZD1775# Wee1 inhibitor solid tumours I Q3 2015
AZD1775# + Lynparza Wee1 inhibitor + PARP inhibitor solid tumours I Q3 2015
AZD1775# + durvalumab# Wee1 inhibitor + PD-L1 mAb solid tumours I Q4 2015
vistusertib (AZD2014) mTOR serine/ threonine kinase inhibitor solid tumours II Q1 2013
AZD3759 BLOOM EGFR tyrosine kinase inhibitor brain metastases in advanced EGFRm NSCLC II Q4 2015
Tagrisso BLOOM EGFR tyrosine kinase inhibitor
AZD5363# AKT kinase inhibitor breast cancer II Q1 2014
AZD4547 FGFR tyrosine kinase inhibitor solid tumours II Q4 2011
inebilizumab# CD19 mAb diffuse B-cell lymphoma II Q1 2012
MEDI-573# IGF mAb metastatic breast cancer II Q2 2012
AZD0156 ATM serine/threonine kinase inhibitor solid tumours I Q4 2015
AZD2811# Aurora B kinase inhibitor solid tumours I Q4 2015
AZD6738 ATR serine/threonine kinase inhibitor solid tumours I Q4 2013
AZD8186 PI3 kinase beta inhibitor solid tumours I Q2 2013
AZD9150# STAT3 inhibitor haematological malignancies I Q1 2012
AZD9496 selective oestrogen receptor downregulator (SERD) ER+ breast cancer I Q4 2014
AZD4635 A2aR inhibitor solid tumours I Q2 2016
MEDI0562# humanised OX40 agonist solid tumours I Q1 2015
MEDI0562# + tremelimumab humanised OX40 agonist + CTLA-4 mAb solid tumours I Q2 2016
MEDI0562# + durvalumab# humanised OX40 agonist + PD-L1 mAb solid tumours I Q2 2016
MEDI-565# CEA BiTE mAb solid tumours I Q1 2011
MEDI0680 PD-1 mAb solid tumours I Q4 2013
MEDI1873 GITR agonist fusion protein solid tumours I Q4 2015
MEDI3617# ANG-2 mAb solid tumours I Q4 2010
MEDI4276 HER2 bispecific ADC mAb solid tumours I Q4 2015
MEDI9197# TLR 7/8 agonist solid tumours I Q4 2015
MEDI9447 CD73 mAb solid tumours I Q3 2015
Infection & Neuroscience
CXL# beta lactamase inhibitor / cephalosporin methicillin-resistant S. aureus II Q4 2010
AZD3241 myeloperoxidase inhibitor multiple system atrophy II Q2 2015(Orphan drug)
MEDI3902 Psl/PcrV bispecific mAb prevention of nosocomial pseudomonas pneumonia II Q2 2016(Fast Track, US)
MEDI4893 mAb binding to S. aureus toxin hospital-acquired pneumonia / serious S. aureus infection II Q4 2014 (Fast Track, US)
MEDI7510 RSV sF+GLA-SE prevention of RSV disease in older adults II Q3 2015
MEDI8852 influenza A mAb influenza A treatment II Q4 2015(Fast Track, US)
MEDI8897# RSV mAb-YTE passive RSV prophylaxis II Q1 2015 (Fast Track, US
ATM AVI# monobactam/ beta lactamase inhibitor targeted serious bacterial infections II Q2 2016
AZD8108 NMDA antagonist suicidal ideation I Q4 2014
MEDI1814 amyloid beta mAb Alzheimer's disease I Q2 2014
MEDI7352 NGF/TNF bispecific mAb osteoarthritis pain I Q1 2016
Q2 2014
MEDI7352
NGF/TNF bispecific mAb
osteoarthritis pain
I
Q1 2016
1 AstraZeneca entered licensing agreement with LEO Pharma (1 July 2016)
2 AstraZeneca announced it granted Ironwood exclusive US rights (26 April 2016) and Grünenthal exclusive rights in
Europe and Latin America (2 June 2016)
Significant Lifecycle Management (LCM)
Respiratory & Autoimmunity
SymbicortSYGMA ICS/LABA as-needed use in mild asthma Q4 2014 N/A 2018 2019
Symbicort ICS/LABA breath actuated Inhaler asthma/COPD 2018
Duaklir Genuair# LAMA/LABA COPD 2018 Launched 2018 2018
Cardiovascular & Metabolic Diseases
Brilinta1 P2Y12 receptor antagonist outcomes trial in patients with prior myocardial infarction Q4 2010 Launched(Priority Review) Launched Accepted Accepted
PEGASUS-
TIMI 54
Brilinta1EUCLID P2Y12 receptor antagonist outcomes trial in patients with peripheral artery disease Q4 2012 2017 2017 2017 2018
Brilinta1THEMIS P2Y12 receptor antagonist outcomes trial in patients with type-2 diabetes and CAD, but without a previous history of MI or stroke Q1 2014 2018 2018 2018 2019
Brilinta1HESTIA P2Y12 receptor antagonist prevention of vaso-occlusive crises in paediatric patients with sickle cell disease Q1 2014 2020 2020
OnglyzaSAVOR-TIMI 53 DPP-4 inhibitor type-2 diabetes outcomes trial Q2 2010 Launched Launched Accepted2
Kombiglyze XR/Komboglyze3 DPP-4 inhibitor/ metformin FDC type-2 diabetes Launched Launched Submitted
Farxiga4 SGLT2 inhibitor type-2 diabetes outcomes trial Q2 2013 2020 2020
DECLARE-
TIMI 58
Farxiga4 SGLT2 inhibitor type-1 diabetes Q4 2014 2018 2017 2018
Xigduo XR/Xigduo5 SGLT2 inhibitor/ metformin FDC type-2 diabetes Launched Launched
Qtern (saxagliptin/dapagliflozin FDC) DPP-4 inhibitor/ SGLT2 inhibitor FDC type-2 diabetes Q2 2012 Accepted Approved6
Bydureon weekly GLP-1 receptor agonist type-2 diabetes Q1 2013 2017 2017
suspension
Bydureon EXSCEL GLP-1 receptor agonist type-2 diabetes outcomes trial Q2 2010 2018 2018 2018
EpanovaSTRENGTH omega-3 carboxylic acids outcomes trial in statin-treated patients at high CV risk, with persistent hypertriglyceridemia plus low HDL-cholesterol Q4 2014 2020 2020 2020 2020
Oncology
FaslodexFALCON oestrogen receptor antagonist 1st-line hormone receptor +ve advanced breast cancer Q4 2012 H2 2016 H2 2016 H2 2016 2020
Lynparza OlympiAD PARP inhibitor gBRCA metastatic breast cancer Q2 2014 2017 2017 2017
Lynparza SOLO-2 PARP inhibitor 2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy Q3 2013 2017(Fast Track) 2017 2017
Lynparza SOLO-1 PARP inhibitor 1st-line BRCAm ovarian cancer Q3 2013 2018 2018 2018
Lynparza SOLO-3 PARP inhibitor gBRCA PSR ovarian cancer Q1 2015 2018
Lynparza POLO PARP inhibitor pancreatic cancer Q1 2015 2018 2018 2018
Lynparza PARP inhibitor prostate cancer Q3 2014 (Breakthrough Therapy)
LynparzaOlympiA PARP inhibitor gBRCA adjuvant breast cancer Q2 2014 2020 2020 2020
Tagrisso FLAURA EGFR tyrosine kinase inhibitor 1st-line advanced EGFRm NSCLC Q1 2015 2017 2017 2017 2017
Tagrisso ADAURA EGFR tyrosine kinase inhibitor adjuvant EGFRm NSCLC Q4 2015 2022 2022 2022 2022
Infection & Neuroscience
Nexium proton pump inhibitor stress ulcer prophylaxis H2 2016
Nexium proton pump inhibitor paediatrics Launched Launched H2 2016 Accepted
linaclotide# GC-C receptor peptide agonist irritable bowel syndrome with constipation N/A N/A N/A Accepted
(IBS-C)
H2 2016
Accepted
linaclotide#
GC-C receptor peptide agonist
irritable bowel syndrome with constipation
(IBS-C)
N/A
N/A
N/A
Accepted
1 Brilinta in the US; Brilique in rest of world
2 Submission filed and accepted July 2016
3 Kombiglyze XR in the US; Komboglyze in the EU
4 Farxiga in the US; Forxiga in rest of world
5 Xigduo XR in the US; Xigduo in the EU
6 EU approval 19 July 2016
Terminations (discontinued projects between 1 April and 30 June 2016)
NME / Line Extension Compound Reason for Discontinuation Area Under Investigation
NME MEDI7836 Safety/Efficacy asthma
NME MEDI6383# Strategic solid tumours
NME durvalumab# + MEDI6383# Strategic solid tumours
NME MEDI0639 Safety/Efficacy solid tumours
LCM Epanova/Farxiga Safety/Efficacy non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH)
LCM Lynparza GOLD Safety/Efficacy 2nd-line gastric cancer
Completed Projects / Divestitures
Compound Mechanism Area Under Investigation Completed/Divested Estimated Regulatory Submission Acceptance†
US EU Japan China
Diprivan#1 sedative and anaesthetic conscious sedation Divested N/A Launched Accepted Launched
1 AstraZeneca announced it entered into a commercialisation agreement with Aspen Global Incorporated (AGI), part of the
Aspen Group, for its global anaethetics portfolio outside of the US on 9 June 2016.
Condensed Consolidated Statement of Comprehensive Income
Product sales 11,034 11,584
Externalisation revenue 684 780
Total revenue 11,718 12,364
Cost of sales (2,066) (2,336)
Gross profit 9,652 10,028
Distribution costs (167) (161)
Research and development expense (2,945) (2,822)
Selling, general and administrative costs (5,624) (5,765)
Other operating income and expense 425 576
Operating profit 1,341 1,856
Finance income 31 24
Finance expense (667) (537)
Share of after tax losses in associates and joint ventures (12) (7)
Profit before tax 693 1,336
Taxation (99) (88)
Profit for the period 594 1,248
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (842) 242
Tax on items that will not be reclassified to profit or loss 235 (57)
(607) 185
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (523) (11)
Foreign exchange arising on designating borrowings in net investment hedges (67) (217)
Cash flow hedge losses (103) -
Cash flow hedge gains transferred to the income statement 60 -
Fair value movements on derivatives designated in net investment hedges (79) 20
Amortisation of loss on cash flow hedge 1 1
Net available for sale losses taken to equity (36) (29)
Tax on items that may be reclassified subsequently to profit or loss 75 43
(672) (193)
Other comprehensive income for the period, net of tax (1,279) (8)
Total comprehensive income for the period (685) 1,240
Profit attributable to:
Owners of the Parent 643
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