27 May 2026 US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data The US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the New Drug Application (NDA) for camizestrant in combination...
26 May 2026 Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer Recommendation based on SERENA-6 Phase III trial results which showed combination reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumour mutation If approved,...
26 May 2026 Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours Based on three Phase II trials of AstraZeneca and Daiichi Sankyo's Enhertu which showed clinically meaningful responses across a broad range of tumours If approved, Enhertu would become the first HER2-directed therapy...
26 May 2026 Datroway approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates AstraZeneca and Daiichi Sankyo's Datroway is the only TROP2-directed antibody drug conjugate to prolong overall survival in this setting vs....
18 May 2026 Transaction by Person Discharging Managerial Responsibilities AstraZeneca PLC (the Company) announced that, on 14 May 2026, an award of the Company's ordinary shares of $0.25 each (Ordinary Shares) vested to Pascal Soriot, Executive Director and Chief Executive Officer, under the terms of the AstraZeneca Performance Share Plan (AZPSP)....
18 May 2026 Enhertu approved in the US for two new indications for patients with HER2-positive early breast cancer Approved for use before surgery based on DESTINY-Breast11 Phase III trial Approved for use following surgery based on DESTINY-Breast05 Phase III trial Two new indications bring AstraZeneca and Daiichi Sankyo's Enhertu into curative-intent...
18 May 2026 Baxfendyapproved in the US as the first and only aldosterone synthase inhibitortreatment for adults with hypertension Approval based on BaxHTN Phase III results showing statistically significant and clinically meaningful reduction in systolic blood pressure in patients with uncontrolled or resistant hypertension Baxfendy 2mg lowered systolic...
14 May 2026 Perioperative Imfinzi plus neoadjuvant EV showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in muscle-invasive bladder cancer in the Phase III VOLGA trial Perioperative Imfinzi plus Imjudo and neoadjuvant EV showed a statistically significant and clinically meaningful improvement...
1 May 2026 Total Voting Rights and Notification of Admission of Further Securities to Trading (PRM 1.6.4R) Total Voting Rights The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6.1....
01 May 2026 Update on FDA Advisory Committee vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR-positive breast cancer The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote in favor of the benefit risk profile of AstraZeneca's camizestrant in combination with a...
01 May 2026 Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer ODAC overwhelming majority voted that Truqap plus abiraterone and ADT demonstrated a favourable benefit risk profile for patients based on the CAPItello-281 Phase III trial results First and only targeted treatment combination to...
29 April 2026 AstraZeneca results: Q1 2026 Strong revenue growth and positive readouts from high-value NMEs reinforce confidence in 2030 ambition Revenue and EPS summary [][] Q1 2026 % Change $m Actual CER[1] - Product Sales 14,386 12 7 - Alliance Revenue 825 29 26 Product Revenue 15,211 13 8 Collaboration Revenue 77 4 - Total Revenue 15,288 13 8 Reported...
28 April 2026 Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older Approval based on KALOS and LOGOS Phase III trials demonstrating statistically significant and clinically meaningful benefits of AstraZeneca's single-inhaler fixed-dose triple therapy compared with inhaled dual therapy Approval is...
27 April 2026 Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus First-in-class Saphnelo Pen now offers greater flexibility and convenience, reaching a wider group of patients AstraZeneca's Saphnelo (anifrolumab) has been approved in the US for self-administration as a...
23 April 2026 Change to AstraZeneca Board of Directors AstraZeneca congratulates Rene Haas on his appointment as Chief Executive Officer of SoftBank Group International, in addition to his position as Chief Executive Officer of Arm Holdings plc....
21 April 2026 Ultomiris demonstrated statistically significant and clinically meaningful reduction of proteinuria in adults with immunoglobulin A nephropathy in I CAN Phase III trial Ultomiris delivered rapid reduction in proteinuria as early as week 10 Results show potential for terminal C5 complement inhibition with Ultomiris as a disease-modifying...
20 April 2026 Tozorakimab met primary endpoint in Phase III MIRANDA trial in patients with COPD Third positive pivotal Phase III clinical trial of AstraZeneca's IL-33-targeting biologic further demonstrates its benefits in COPD Positive high-level results from the pivotal Phase III MIRANDA trial showed potential first-in-class tozorakimab demonstrated a...
9 April 2026 Results of Annual General Meeting held on 9 April 2026 AstraZeneca PLC announced the results of the voting at its Annual General Meeting (AGM) today. As proposed in the Notice of AGM, all Resolutions were decided by poll vote. Resolutions 10 - 13 were passed as special resolutions; all other resolutions were passed as ordinary resolutions....
2 April 2026 Imfinzi plus Imjudo combined with lenvatinib and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial Imfinzi plus Imjudo combined with lenvatinib and transarterial chemoembolisation (TACE) showed trend...
1 April 2026 Total Voting Rights and Notification of Admission of Further Securities to Trading (PRM 1.6.4R) Total Voting Rights The following notification is made in accordance with the UK Financial Conduct Authority's Disclosure and Transparency Rule 5.6.1....
This announcement contains inside information 31 March 2026 Efzimfotase alfa demonstrated positive results from global Phase III clinical programme in hypophosphatasia MULBERRY randomised, placebo-controlled trial showed efzimfotase alfa demonstrated statistically significant and clinically meaningful improvement in bone health in treatment-na•ve paediatric...
This announcement contains inside information 27 March 2026 Tozorakimab met primary endpoint in both OBERON and TITANIA Phase III trials in patients with COPD First-ever IL-33-targeting biologic to demonstrate statistically significant and highly clinically meaningful reductions in COPD exacerbations in two replicate Phase III clinical trials Positive...
20 March 2026 Notification of Admission of Further Securities to Trading (PRM 1.6.4R) AstraZeneca PLC (the Company) announced today the following information in accordance with The Public Offers and Admissions to Trading Regulations 2024 (POATRs) PRM 1.6.4R....
16 March 2026 Imfinzi approved in the EU as first and only perioperative immunotherapy for patients with early gastric and gastroesophageal cancers Approval based on MATTERHORN Phase III trial demonstrating statistically significant and clinically meaningful improvements in event-free survival and overall survival AstraZeneca's Imfinzi (durvalumab) in...
10 March 2026 Notice of Annual General Meeting AstraZeneca PLC (the Company) announced today the publication of its Notice of Annual General Meeting 2026 and Shareholders' Circular (the Notice). The Company's Annual General Meeting (AGM) will be digitally-enabled and will be held on Thursday 9 April 2026 at 14:30 (BST)....