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2024-11-12 Kvartalsrapport 2024-Q3
2024-07-25 Kvartalsrapport 2024-Q2
2024-04-25 Kvartalsrapport 2024-Q1
2024-04-11 Årsstämma 2024
2024-02-22 X-dag halvårsutdelning AZN 20.65
2024-02-08 Bokslutskommuniké 2023
2023-11-09 Kvartalsrapport 2023-Q3
2023-08-10 X-dag halvårsutdelning AZN 9.64
2023-07-28 Kvartalsrapport 2023-Q2
2023-04-27 Årsstämma 2023
2023-04-27 Kvartalsrapport 2023-Q1
2023-02-23 X-dag halvårsutdelning AZN 20.69
2023-02-09 Bokslutskommuniké 2022
2022-11-10 Kvartalsrapport 2022-Q3
2022-08-11 X-dag halvårsutdelning AZN 9.49
2022-07-29 Kvartalsrapport 2022-Q2
2022-04-29 Kvartalsrapport 2022-Q1
2022-04-29 Årsstämma 2022
2022-02-24 X-dag halvårsutdelning AZN 18
2022-02-10 Bokslutskommuniké 2021
2021-11-12 Kvartalsrapport 2021-Q3
2021-08-12 X-dag halvårsutdelning AZN 7.72
2021-07-29 Kvartalsrapport 2021-Q2
2021-05-11 Årsstämma 2021
2021-04-30 Kvartalsrapport 2021-Q1
2021-02-25 X-dag halvårsutdelning AZN 15.76
2021-02-11 Bokslutskommuniké 2020
2020-11-05 Kvartalsrapport 2020-Q3
2020-08-13 X-dag halvårsutdelning AZN 7.87
2020-07-30 Kvartalsrapport 2020-Q2
2020-04-29 Årsstämma 2020
2020-04-29 Kvartalsrapport 2020-Q1
2020-02-27 X-dag halvårsutdelning AZN 18.32
2020-02-14 Bokslutskommuniké 2019
2019-10-24 Kvartalsrapport 2019-Q3
2019-08-08 X-dag halvårsutdelning AZN 8.49
2019-07-25 Kvartalsrapport 2019-Q2
2019-04-26 Kvartalsrapport 2019-Q1
2019-04-26 Årsstämma 2019
2019-02-28 X-dag halvårsutdelning AZN 17.46
2019-02-14 Bokslutskommuniké 2018
2018-11-08 Kvartalsrapport 2018-Q3
2018-08-09 X-dag halvårsutdelning AZN 7.92
2018-07-26 Kvartalsrapport 2018-Q2
2018-05-18 Kvartalsrapport 2018-Q1
2018-05-18 Årsstämma 2018
2018-02-15 X-dag halvårsutdelning AZN 14.97
2018-02-02 Bokslutskommuniké 2017
2017-11-09 Kvartalsrapport 2017-Q3
2017-08-10 X-dag halvårsutdelning AZN 7.4
2017-07-27 Kvartalsrapport 2017-Q2
2017-04-27 Årsstämma 2017
2017-04-27 Kvartalsrapport 2017-Q1
2017-02-16 X-dag halvårsutdelning AZN 16.57
2017-02-02 Bokslutskommuniké 2016
2016-11-10 Kvartalsrapport 2016-Q3
2016-08-11 X-dag halvårsutdelning AZN 7.81
2016-07-28 Kvartalsrapport 2016-Q2
2016-04-29 Kvartalsrapport 2016-Q1
2016-04-29 Årsstämma 2016
2016-02-18 X-dag halvårsutdelning AZN 16.26
2016-02-04 Bokslutskommuniké 2015
2015-11-05 Kvartalsrapport 2015-Q3
2015-08-13 X-dag halvårsutdelning AZN 7.71
2015-07-30 Kvartalsrapport 2015-Q2
2015-04-24 Kvartalsrapport 2015-Q1
2015-04-24 Årsstämma 2015
2015-02-19 X-dag halvårsutdelning AZN 15.62
2015-02-05 Bokslutskommuniké 2014
2014-11-06 Kvartalsrapport 2014-Q3
2014-08-13 X-dag halvårsutdelning AZN 6.2
2014-07-31 Kvartalsrapport 2014-Q2
2014-04-24 Kvartalsrapport 2014-Q1
2014-04-24 Årsstämma 2014
2014-02-19 X-dag halvårsutdelning AZN 12.41
2014-02-06 Bokslutskommuniké 2013
2013-10-31 Kvartalsrapport 2013-Q3
2013-08-14 X-dag halvårsutdelning AZN 5.92
2013-08-01 Kvartalsrapport 2013-Q2
2013-08-01 Analytiker möte 2013
2013-04-25 Kvartalsrapport 2013-Q1
2013-04-25 Årsstämma 2013
2013-02-13 X-dag halvårsutdelning AZN 12.08
2013-01-31 Bokslutskommuniké 2012
2012-10-25 Kvartalsrapport 2012-Q3
2012-10-25 Analytiker möte 2012
2012-08-08 X-dag halvårsutdelning AZN 6.26
2012-07-26 Kvartalsrapport 2012-Q2
2012-04-26 Kvartalsrapport 2012-Q1
2012-04-26 Årsstämma 2012
2012-02-15 X-dag halvårsutdelning AZN 13.21
2012-02-02 Bokslutskommuniké 2011
2011-10-27 Kvartalsrapport 2011-Q3
2011-08-03 X-dag halvårsutdelning AZN 5.33
2011-07-28 Kvartalsrapport 2011-Q2
2011-04-28 Årsstämma 2011
2011-04-28 Kvartalsrapport 2011-Q1
2011-02-02 X-dag halvårsutdelning AZN 11.99
2011-01-27 Bokslutskommuniké 2010
2010-10-28 Kvartalsrapport 2010-Q3
2010-08-04 X-dag halvårsutdelning AZN 5.12
2010-07-29 Kvartalsrapport 2010-Q2
2010-04-29 Kvartalsrapport 2010-Q1
2010-02-03 X-dag halvårsutdelning AZN 12.43
2010-01-28 Bokslutskommuniké 2009
2009-10-29 Kvartalsrapport 2009-Q3
2009-08-05 X-dag halvårsutdelning AZN 4.41
2009-07-30 Kvartalsrapport 2009-Q2
2009-04-30 Kvartalsrapport 2009-Q1
2009-04-30 Årsstämma 1
2009-02-04 X-dag halvårsutdelning AZN 12.02
2008-08-06 X-dag halvårsutdelning AZN 3.34
2008-02-06 X-dag halvårsutdelning AZN 8.61
2007-08-08 X-dag halvårsutdelning AZN 3.49
2007-02-07 X-dag halvårsutdelning AZN 8.6
2006-08-09 X-dag halvårsutdelning AZN 3.6
2006-02-08 X-dag halvårsutdelning AZN 7.02
2005-08-10 X-dag halvårsutdelning AZN 2.99
2005-02-09 X-dag halvårsutdelning AZN 4.497
2004-08-11 X-dag halvårsutdelning AZN 2.2
2004-02-18 X-dag halvårsutdelning AZN 3.91
2003-08-20 X-dag halvårsutdelning AZN 2.07
2003-02-19 X-dag halvårsutdelning AZN 3.99
2002-08-21 X-dag halvårsutdelning AZN 2.21
2002-02-20 X-dag halvårsutdelning AZN 5.01
2001-08-22 X-dag halvårsutdelning AZN 2.44
2001-02-21 X-dag halvårsutdelning AZN 4.49
2000-09-04 X-dag halvårsutdelning AZN 2.1
2000-03-08 X-dag halvårsutdelning AZN 4.01
1999-09-06 X-dag halvårsutdelning AZN 1.89
1999-04-01 Split AZN 1:0.5045
1997-05-26 Split AZN 1:2
1993-06-14 Split AZN 1:5
1987-06-04 Split AZN 1:2

Beskrivning

LandStorbritannien
ListaLarge Cap Stockholm
SektorHälsovård
IndustriLäkemedel & Handel
AstraZeneca är ett globalt läkemedelsbolag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom terapiområdena som berör andningsvägar, hjärta/kärl/metabolism och cancer. Utöver huvudverksamheten är bolaget även aktiva inom autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt inom samtliga globala regioner och har sitt huvudkontor i Cambridge, Storbritannien.
2024-05-16 08:01:17

Positive high-level results from the SUPERNOVA Phase III COVID-19 pre-exposure prophylaxis (prevention) trial showed AstraZeneca's sipavibart (formerly AZD3152), an investigational long-acting antibody (LAAB), demonstrated a statistically significant reduction in the incidence of symptomatic COVID-19 compared to control (tixagevimab/cilgavimab or placebo) in an immunocompromised patient population.

The trial met both dual primary endpoints; the first one being the relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and the second being the relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation. SUPERNOVA demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.

SUPERNOVA is a large Phase III global trial providing the only efficacy data in immunocompromised patients, demonstrating the potential benefit of a COVID-19 antibody against recent SARS-CoV-2 variants. Immunocompromised patients include those with blood cancer, organ transplant recipients, patients with end-stage renal disease requiring dialysis, patients receiving B-cell depleting therapy within the past year, and those taking immunosuppressive medications. Despite accounting for approximately 4% of the population, immunocompromised patients make up about 25% of COVID-19 hospitalisations, ICU admissions, and deaths, even after multiple doses of COVID-19 vaccines.[1-6]

Ghady Haidar, M.D., UPMC (University of Pittsburgh Medical Center) transplant infectious diseases physician, medical director of the translational research program at UPMC's division of infectious diseases and SUPERNOVA trial primary investigator, said: "COVID-19 still represents a significant and disproportionate risk for immunocompromised patients, with infection often leading to serious and protracted illness. By delivering infection-fighting antibodies directly to patients who often don't respond adequately to vaccines, the data support that sipavibart has the potential to provide much-needed protection against COVID-19 in this highly vulnerable population."

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: "Immunocompromised patients currently have limited or no options for COVID-19 protection and continue to face a significant burden of disease, despite often being fully vaccinated. Sipavibart has the potential to prevent COVID-19 in the immunocompromised and we will now work with regulatory authorities globally to bring sipavibart to these vulnerable patients."

Sipavibart was well tolerated in the trial and preliminary analyses show adverse events were balanced between the control and sipavibart arms.

The data will be presented at a forthcoming medical meeting. AstraZeneca is in dialogue with regulatory authorities on potential authorisation or approval pathways.   

Notes

SUPERNOVA

SUPERNOVA is a Phase III, global, randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of sipavibart compared to control (tixagevimab/cilgavimab or placebo) for the prevention of COVID-19. The trial was conducted at 197 sites in the US, UK, EU and Asia. Participants were randomised in a 1:1 ratio to receive either a 300mg intramuscular dose of sipavibart or comparator, with 1,669/3,335 participants receiving sipavibart and 1,666/3,335 receiving comparator. A second dose of sipavibart or comparator was given approximately six months after initial receipt of study product.

The trial had dual primary efficacy endpoints. The first evaluated the efficacy of sipavibart against any confirmed SARS-CoV-2 positive symptomatic illness occurring post dose prior to day 181 caused by any variant (i.e., all cases regardless of if the variant has the F456L mutation or not, which sipavibart is not expected to neutralise). The second dual primary efficacy analysis was conducted using only the confirmed COVID-19 cases in the trial where the variant causing the COVID-19 cases did not have the F456L mutation, referred to as a "matched" variant analysis.  

Participants were individuals 12 years of age and over who would benefit from prevention with the investigational LAAB, defined as having increased risk for inadequate response to active immunisation (predicted poor responders to vaccines or intolerant of vaccine). Participants at the time of screening had a negative point-of-care SARS-CoV-2 serology test. Participants will be followed for 15 months, with SARS-CoV-2 neutralising antibodies assessed at one, three and six months.

All participants in the trial had an immunocompromising condition and/or were on immunosuppressive treatments, which put them at risk to mount an inadequate immune response to vaccination and at high risk of developing severe COVID-19. This included patients with hematologic malignancies, solid organ transplant recipients, hematopoietic stem cell transplants, end stage kidney disease/dialysis and being within one year of receipt of B cell depleting therapy, among others. Across the treatment groups, demographic and baseline characteristics were generally well balanced.

Sipavibart

Sipavibart (formerly AZD3152) is an investigational long-acting monoclonal antibody (LAAB) against COVID-19. Sipavibart was designed to provide broad and potent coverage across Omicron and ancestral viral variants by neutralising spike protein interaction with the host receptor ACE2.[7]

Sipavibart was derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. Sipavibart has been engineered using the same antibody scaffold as Evusheld and was optimised with the same half-life extension and reduced Fc effector function and complement C1q binding platform.[7] The reduced Fc effector function aims to minimise the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.

Sipavibart was licensed by AstraZeneca in May 2022 from RQ Biotechnology (https://www.astrazeneca.com/media-centre/press-releases/2022/astrazeneca-signs-licence-agreement-with-rq-biotechnology-for-monoclonal-antibodies-against-covid-19.html).

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the Company on Social Media @AstraZeneca (https://twitter.com/AstraZeneca).

Contacts

For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).

References

1. Evans RA et al. Impact of COVID-19 on Immunocompromised Populations during the Omicron Era: Insights from the Observational Population-Based INFORM Study. The Lancet Regional Health - Europe. 2023;0(0):100747. doi:10.1016/J.LANEPE.2023.100747
2. Dube S. Continued Increased Risk of COVID-19 Hospitalisation and Death in Immunocompromised Individuals Despite Receipt of ≥4 Vaccine Doses: Updated 2023 Results from INFORM, a Retrospective Health Database Study in England. Poster P0409 at ECCMID 2024. 
3. Turtle L. Individuals with Multiple Sclerosis Are at High Risk for COVID-19 Hospitalisation and Death Despite High Rates of Vaccination: Results from the England INFORM Study. Oral Presentation at ECCMID 2024. 
4. Meeraus W. High Prevalence of Immunocompromising Conditions Among Patients with Severe Acute Respiratory Infection, Including SARS-CoV-2: Results from a Multicentre, Test-Negative Case Control Study. Abstract #01796 at ECCMID 2024. 
5. Meeraus W. Immunocompromise, Cancer and Other Comorbidities in Patients with Severe Acute Respiratory Infection Testing Positive Versus Negative for SARS-CoV-2: A Post Hoc Analysis of COVIDRIVE Data from May 2021 to May 2023. Abstract #01800 at ECCMID 2024.
6. Ketkar A et al. Assessing the Risk and Costs of COVID-19 in Immunocompromised Populations in a Large United States Commercial Insurance Health Plan: The EPOCH-US Study. Curr Med Res Opin. 2023. 39 (8):1103-1118.
7. Francica JR, Cai Y, Diallo S, et al. 1355. The SARS-CoV-2 Monoclonal Antibody AZD3152 Potently Neutralizes Historical and Emerging Variants and is Being Developed for the Prevention and Treatment of COVID-19 in High-risk Individuals. Open Forum Infect Dis. 2023 Nov 27;10(Suppl 2):ofad500.1192. doi: 10.1093/ofid/ofad500.1192.