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  • AstraZeneca
    Karlebyhus, Astraallén 151 85 SÖDERTÄLJE
    08-553 260 00
    08-553 290 00
    http://www.astrazeneca.se
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    AstraZeneca invests $3.5 billion in US

    12 November 2024 AstraZeneca invests $3.5 billionin R&D and manufacturing in the United States AstraZeneca today announces $3.5 billion of capital investment in the United States focused on expanding the Company's research and manufacturing footprint by the end of 2026. This includes $2 billion of new investment creating more than a thousand new, high-skilled jobs contributing to the growth of the US economy. AstraZeneca's expanding footprint in the US includes, among others: ·       A state-of-the-art R&D centre in Kendall Square, Cambridge, Massachusetts ·       A next

    KOMET Phase III trial met primary endpoint

    12 November 2024 Koselugo showed statistically significant and clinically meaningful objective response rate vs. placebo in adults with neurofibromatosis type 1 in global KOMET Phase III trial Results demonstrated reduction in tumour volume, building on established safety and efficacy profile of Koselugo in children and supporting expanded use in adults Positive high-level results of KOMET, the largest, global randomised double-blind placebo-controlled multicentre Phase III trial in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (

    Dato-DXd new BLA submitted, NSQ BLA withdrawn

    12 November 2024 Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer AstraZeneca and Daiichi Sankyo's new application is based on the TROPION-Lung05 Phase II trial and supported by data from additional trials including TROPION-Lung01   Previously submitted BLA based on TROPION-Lung01 Phase III trial for patients with nonsquamous NSCLC has been voluntarily withdrawn AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated

    Tezspire nasal polyps trial met primary endpoints

    08 November 2024 Tezspire met both co-primary endpoints in the Phase III WAYPOINT trial in patientswith chronic rhinosinusitis with nasal polyps Tezspire demonstrated a statistically significant and clinically meaningful reduction innasal polyp size and reduced nasal congestion compared to placebo Positive high-level results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) showed that AstraZeneca and Amgen's Tezspire (tezepelumab) demonstrated a statistically significant and clinically meaningful reduction in

    Total Voting Rights

    1 November 2024 15:00 GMT Transparency DirectiveVoting rights and capital The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6.1. As at 31 October 2024 the issued share capital of AstraZeneca PLC with voting rights is 1,550,303,887 ordinary shares of US$0.25. No shares are held in Treasury. Therefore, the total number of voting rights in AstraZeneca PLC is 1,550,303,887. The above figure for the total number of voting rights may be used by shareholders as the denominator for the calculations by which they

    AZN China President under investigation

    This announcement contains inside information 30 October 2024 AstraZeneca China President currently under investigation Leon Wang, Executive Vice President International and AstraZeneca China President, is cooperating with an ongoing investigation by Chinese authorities. Our China operations continue under the leadership of the current General Manager of AstraZeneca China. If requested, AstraZeneca will fully cooperate with the investigation. AstraZenecaAstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery,

    Wainzua recommended for approval in the EU

    21 October 2024 Wainzua (eplontersen) recommended for approval in the EU by CHMP for the treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis Recommendation based on NEURO-TTRansform Phase III results showing Wainzua demonstrated consistent and sustained benefit improving neuropathy impairment and quality of life versus placebo AstraZeneca and Ionis' Wainzua (eplontersen) has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) for the treatment of hereditary

    AstraZeneca licenses lipid lowering Lp(a) asset

    7 October 2024 AstraZeneca strengthens its cardiovascular pipeline with agreement for a pre-clinical novel lipid-lowering therapy AstraZeneca has entered into an exclusive license agreement with CSPC Pharmaceutical Group Ltd (CSPC) to advance the development of an early stage, novel small molecule Lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidaemia. This asset further strengthens the company's cardiovascular portfolio to help address the major risk factors driving chronic cardiovascular disease.   Under the terms of

    Total Voting Rights

    1 October 2024 15:00 BST Transparency DirectiveVoting rights and capital The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6.1. As at 30 September 2024 the issued share capital of AstraZeneca PLC with voting rights is 1,550,294,658 ordinary shares of US$0.25. No shares are held in Treasury. Therefore, the total number of voting rights in AstraZeneca PLC is 1,550,294,658. The above figure for the total number of voting rights may be used by shareholders as the denominator for the calculations by which they

    Tagrisso US approval in unresectable lung cancer

    26 September 2024  Tagrisso approved in the US for patients withunresectable, Stage III EGFR-mutated lung cancer Based on LAURA Phase III trial results which showed Tagrissoextended median progression-free survival by more than three years AstraZeneca's Tagrisso (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT).

    Fasenra recommended for EU approval in EGPA

    23 September 2024 Fasenrarecommended for approval in the EU by CHMP for the treatment ofeosinophilic granulomatosis with polyangiitisNew indication supported by the MANDARA trial which showed nearly 60% of patientsachieved remission and 41% of patients fully stopped taking oral corticosteroids  AstraZeneca's Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in

    Final OS results reported for TROPION-Breast01

    23 September 2024 Datopotamab deruxtecan final overall survival results reported inpatients with metastatic HR-positive, HER2-low or negative breast cancer inTROPION-Breast01 Phase III trial  Survival results for AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan in TROPION-Breast01 did not achieve statistical significance versus chemotherapy Trial previously met the dual primaryendpoint of progression-free survival High-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) compared to investigator's choice of chemotherapy,

    FluMist approved for self-administration in US

    20 September 2024 FluMist approved for self-administration in the US Only influenza vaccine approved for self- or caregiver-administration at home, expanding options for influenza protection FluMist has been approved in the US as the only self-administered influenza vaccine. FluMist, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.[1] The approval by the US Food and Drug Administration (FDA) was based on a comprehensive submission, which included results from a

    FASENRA EGPA US FDA APPROVAL

    18 September 2024 Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids AstraZeneca's Fasenra (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).[1] EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.[2,3] The approval by the US Food and

    Director/PDMR Shareholding

    13 September 2024 15:15 BST Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announces that Michel Demaré, Non-Executive Chair of the Board, purchased 2,000 of the Company's ordinary shares of $0.25 each (Ordinary Shares) on 13 September 2024. Further details are set out in the attached notification, made in accordance with the requirements of the EU Market Abuse Regulation (since it forms part of UK law pursuant to the European Union (Withdrawal) Act 2018). 1 Details of the person discharging managerial responsibilities /

    Total Voting Rights

    2 September 2024 15:00 BST Transparency DirectiveVoting rights and capital The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6.1. As at 31 August 2024 the issued share capital of AstraZeneca PLC with voting rights is 1,550,286,637 ordinary shares of US$0.25. No shares are held in Treasury. Therefore, the total number of voting rights in AstraZeneca PLC is 1,550,286,637. The above figure for the total number of voting rights may be used by shareholders as the denominator for the calculations by which they

    Imfinzi approved in US for resectable lung cancer

    16 August 2024  Imfinzi approved in the US for the treatment of resectablenon-small cell lung cancer before and after surgeryBased on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk ofrecurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma

    Total Voting Rights

    1 August 2024 15:00 BST Transparency DirectiveVoting rights and capital The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6.1. As at 31 July 2024 the issued share capital of AstraZeneca PLC with voting rights is 1,550,277,001 ordinary shares of US$0.25. No shares are held in Treasury. Therefore, the total number of voting rights in AstraZeneca PLC is 1,550,277,001. The above figure for the total number of voting rights may be used by shareholders as the denominator for the calculations by which they will

    AstraZeneca prices a €1.4bn bond offering

    30 July 2024 07:00 BST AstraZeneca prices €1.4 billion bond offering AstraZeneca PLC (the Company) announces that, on 29 July 2024, its wholly owned subsidiary AstraZeneca Finance LLC, successfully priced two tranches of Eurobonds totalling €1.4 billion (the Offering). The Offering is expected to close on 5 August 2024, subject to customary closing conditions. The Offering consisted of the following notes, issued by AstraZeneca Finance LLC and fully and unconditionally guaranteed by the Company: · €650 million of fixed rate notes with a coupon of 3.121% maturing on 5 August

    Calquence fixed-duration combo improved 1L CLL PFS

    29 July 2024 Fixed-duration Calquence plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival in 1st-line chronic lymphocytic leukaemia in AMPLIFY Phase III trial Favourable trend in overall survival was also observed Positive high-level results from an interim analysis of the AMPLIFY Phase III trial showed a fixed duration of AstraZeneca's Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS)

    ODAC reviewed Imfinzi in resectable lung cancer

    26 July 2024 FDA Advisory Committee reviewed Imfinzi for treatment of resectable non-small cell lung cancer based on AEGEAN Phase III trial results The Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca's Imfinzi (durvalumab) met the primary endpoint of event-free survival (EFS) in the treatment of resectable non-small cell lung cancer (NSCLC) based on the AEGEAN Phase III trial results with an overall tolerable safety profile. In the trial, adult patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal

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