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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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    Enhertu approved in US for breast cancer post ET

    28 January 2025 Enhertu approved in the US as first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapiesBased on DESTINY-Breast06 Phase III trial results which showed Enhertu demonstrated superiority vs. chemotherapy with a median progression-free survival of more than one yearApproval brings AstraZeneca and Daiichi Sankyo's Enhertu to an earlier HR-positive treatment setting and broadens the patient population eligible for treatment with a HER2-directed therapy to those with

    Dato-DXd approved in US for HR+ breast cancer

    20 January 2025 Datroway (datopotamab deruxtecan) approved in the US for patients withpreviously treated metastatic HR-positive, HER2-negative breast cancer First approval in the US for AstraZeneca and Daiichi Sankyo's Datroway based on TROPION-Breast01 results showing 37% reduction in the risk of disease progression or death vs. chemotherapy Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030 Datroway (datopotamab deruxtecan or Dato-DXd) has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone

    Calquence combination approved in US for 1L MCL

    17 January 2025 Calquence plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone First and only BTK inhibitor approved for the 1st-line treatment of MCL in the US AstraZeneca's Calquence (acalabrutinib) in combination with bendamustine and rituximab has been approved in the US for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for

    Total Voting Rights

    2 January 2025 Transparency Directive Voting 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 December 2024 the issued share capital of AstraZeneca PLC with voting rights is 1,550,546,239 ordinary shares of US$0.25. No shares are held in Treasury. Therefore, the total number of voting rights in AstraZeneca PLC is 1,550,546,239. 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

    Dato-DXd NSQ NSCLC application withdrawn in EU

    24 December 2024 Datopotamab deruxtecan application in the EU for patients with advancednonsquamous non-small cell lung cancer voluntarily withdrawn AstraZeneca and Daiichi Sankyo have voluntarily withdrawn the marketing authorisation application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01  Phase III trial. The decision to withdraw the MAA was informed by feedback from the

    Tagrisso approved in EU based on LAURA trial

    23 December 2024 Tagrisso approved in the EU for patientswith unresectable EGFR-mutated lung cancer  First and only EGFR inhibitor and targeted treatmentapproved in the EU in unresectable NSCLC Approval based on LAURA Phase III trial results which showed Tagrissoextended median progression-free survival to more than three years AstraZeneca's Tagrisso (osimertinib) has been approved in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR)

    Directorate Change

    16 December 2024 07:00 GMT Non-Executive Board Appointments AstraZeneca PLC announced today that Rene Haas and Birgit Conix have been appointed as Non-Executive Directors with effect from 1 January 2025 and 1 February 2025 respectively. Birgit will become a member of the Audit Committee on appointment to the Board. Rene is Chief Executive Officer of Arm. Birgit is Chief Financial Officer of Sonova. Further biographical details are set out below. Michel Demaré, Chair of AstraZeneca, said "I am confident Rene and Birgit will be excellent additions to the AstraZeneca Board.  We

    Imfinzi approved in US for limited-stage SCLC

    5 December 2024 Imfinzi approved in the US as first and only immunotherapyregimen for patients with limited-stage small cell lung cancer  Based on ADRIATIC Phase III trial results which showed a 27% reduction in the risk of death versus placebo AstraZeneca's Imfinzi (durvalumab) has been approved in the US for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted by the Food and Drug Administration (FDA) after securing

    AstraZeneca appoints Iskra Reic EVP International

    4 December 2024 AstraZeneca appoints Iskra Reic as Executive Vice President, International AstraZeneca today announced the appointment of Iskra Reic as Executive Vice President (EVP), International with responsibility for overall strategy and driving sustainable growth across this broad region. This encompasses China, Asian and Eurasian markets, Middle East & Africa, Latin America, Australia & New Zealand. Having joined the Company in 2001, Iskra has held leadership positions across Central & Eastern Europe, Eurasia, Middle East & Africa. She was appointed EVP for Europe & Canada

    Total Voting Rights

    2 December 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 30 November 2024 the issued share capital of AstraZeneca PLC with voting rights is 1,550,317,189 ordinary shares of US$0.25. No shares are held in Treasury. Therefore, the total number of voting rights in AstraZeneca PLC is 1,550,317,189. The above figure for the total number of voting rights may be used by shareholders as the denominator for the calculations by which they

    Truqap improved rPFS in advanced prostate cancer

    25 November 2024 Truqap combination in PTEN-deficient metastatic hormone-sensitiveprostate cancer demonstrated statistically significant and clinically meaningfulimprovement in radiographic progression-free survivalin CAPItello-281 Phase III trial First and only AKT inhibitor combination to demonstratebenefit in this specific subtype of prostate cancer Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically

    Director/PDMR Shareholding

    20 November 2024 16:00 GMT Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announces that it was notified on 20 November 2024 that Tony Mok, Non-Executive Director, purchased 3,000 of the Company's American Depositary Shares (ADSs) on 19 November 2024, as set out below. Two ADSs are equivalent to one of the Company's ordinary shares of $0.25 each. PDMR  Position  Nature of the transaction  Quantity  Price Tony Non-Executive Director Purchase of ADSs  3,000 US$63.40Mok Further details are set out

    Tagrisso recommended for EU approval - LAURA

    18 November 2024 Tagrisso recommended for approval in the EU by CHMPfor patients with unresectable EGFR-mutated lung cancer  Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years AstraZeneca's Tagrisso (osimertinib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution

    Director/PDMR Shareholding

    15 November 2024 14:00 GMT Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announces that it was notified 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 15 November 2024, as set out below. PDMR  Position  Nature of the transaction  Quantity  Price Michel Non-Executive Purchase of Ordinary Shares  2,000 GB£100.30Demaré Chair of the Board Further details are set out in the attached notification, made in

    Director/PDMR Shareholding

    15 November 2024 10:00 GMT Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announces that it was notified on 14 November 2024 that Pascal Soriot, Chief Executive Officer, purchased 20,000 of the Company's ordinary shares of $0.25 each (Ordinary Shares) on 14 November 2024, as set out below. PDMR Position Nature of the transaction Quantity PricePascal Chief Purchase of Ordinary Shares  20,000 GB£102.03Soriot Executive Officer Further details are set out in the attached notification, made in

    Director/PDMR Shareholding

    13 November 2024 16:00 GMT Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announces that Philip Broadley, Senior independent Non-Executive Director, purchased 980 of the Company's ordinary shares of $0.25 each (Ordinary Shares) today, 13 November 2024, as set out below. PDMR  Position  Nature of the Quantity  Price  transaction Philip Senior Purchase of 980 GB£101.70Broadley  independent Non Ordinary -Executive Director

    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

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