Welcome to our dedicated page for AstraZeneca SEC filings (Ticker: AZN), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
AstraZeneca PLC filings document the disclosures of a foreign private issuer focused on prescription medicines across oncology, rare diseases, cardiovascular, renal and metabolism, respiratory, and immunology. The company’s Form 6-K reports include quarterly operating results, product sales, alliance and collaboration revenue, EPS measures, and management commentary on medicine performance and pipeline progress.
Other filings record FDA advisory-committee and approval updates for medicines such as TRUQAP, BREZTRI, SAPHNELO, camizestrant, and ULTOMIRIS; Phase III trial disclosures; licensing arrangements; Board changes; total voting rights; and admission of additional ordinary shares. These documents also provide capital-structure and governance information relevant to AstraZeneca’s UK issuer framework and SEC foreign-issuer reporting obligations.
AstraZeneca PLC has entered an exclusive global license agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib), a novel oral irreversible EGFR inhibitor for certain lung cancer patients. AstraZeneca will obtain worldwide rights to develop and commercialise Zegfrovy, paying Dizal $600m upfront and up to $900m in development, regulatory and sales-related milestones, plus tiered royalties on global sales. The transaction is expected to close in the second half of 2026, subject to customary conditions, and does not affect AstraZeneca’s 2026 financial guidance.
Zegfrovy is already approved in the US and China for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy. Dizal has reported positive Phase III WU-KONG28 results in 1st-line NSCLC with these mutations, supporting Supplemental New Drug Applications filed with the US FDA and China’s CDE, both of which have granted Breakthrough Therapy Designation for this setting. Zegfrovy is included in the NCCN NSCLC Guidelines as a Category 2A subsequent therapy option, and AstraZeneca positions it as complementing its existing EGFR-focused lung cancer portfolio.
AstraZeneca PLC reported that the CARDIO-TTRansform Phase III trial of Wainua (eplontersen) in adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) did not meet its primary efficacy endpoint. Adding Wainua to standard care did not significantly reduce the composite of cardiovascular mortality and recurrent cardiovascular events through Week 140 versus placebo.
Wainua was generally well tolerated with a safety profile consistent with earlier data. A prespecified subgroup on Wainua monotherapy showed fewer composite events with a nominally significant result, while patients already on stabiliser therapy showed no treatment effect. The trial enrolled 1,432 participants across 20 countries, randomised to 45 mg Wainua or placebo every four weeks, and full data will be shared at the European Society of Cardiology Congress in August 2026.
AstraZeneca PLC officer Mani Sharma reported a small share-based compensation award. On July 6, 2026, Sharma acquired 2 Ordinary Shares in a grant/award transaction at $190.43 per share, linked to the company’s Share Incentive Plan at GBP142.492 per share. The price was converted using a GBP1.0000 to $1.3364 rate published on July 2, 2026. After this award, Sharma directly holds 19,265.4659 Ordinary Shares, reflecting a routine compensation-related acquisition rather than an open-market purchase.
AstraZeneca PLC has admitted a further 14,784 ordinary shares of $0.25 each to trading on the Main Market of the London Stock Exchange. These shares were issued between 1 June 2026 and 30 June 2026 under the company’s existing block admission dated 29 January 2021.
Following this admission, the total number of AstraZeneca ordinary shares in issue is 1,551,024,534. The new shares are fully fungible with existing ordinary shares and arise from the company’s employee share schemes.
AstraZeneca PLC has updated investors on its share capital and voting rights. As at 30 June 2026, the company had 1,551,024,534 ordinary shares of US$0.25 each in issue, all carrying voting rights. No shares are held in treasury, so the total number of voting rights is 1,551,024,534. Shareholders can use this figure as the denominator when calculating whether they must notify holdings or changes in holdings under the UK Financial Conduct Authority's Disclosure and Transparency Rules.
AstraZeneca reports that the European Union has approved Enhertu (trastuzumab deruxtecan), co-developed with Daiichi Sankyo, as the first tumour‑agnostic HER2‑directed antibody drug conjugate. It is cleared as monotherapy for adults with previously treated unresectable or metastatic HER2‑positive (IHC 3+) solid tumours who lack satisfactory options.
The decision is based on three Phase II trials. In DESTINY‑PanTumor02, Enhertu achieved a confirmed objective response rate of 52.3% and median duration of response of 21.1 months in IHC 3+ solid tumours. Following EU approval, AstraZeneca will pay Daiichi Sankyo a $25 million milestone under their 2019 collaboration agreement.
AstraZeneca reports that Datroway (datopotamab deruxtecan), co-developed with Daiichi Sankyo, has received a positive opinion from the EMA’s CHMP as a 1st-line monotherapy for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy in the EU.
The recommendation is based on the Phase III TROPION-Breast02 trial, where Datroway improved median overall survival by 5.0 months to 23.7 months versus 18.7 months with chemotherapy and reduced the risk of disease progression or death by 43% (hazard ratio 0.57; p<0.0001). Objective response rate was 62.5% with Datroway versus 29.3% with chemotherapy, with a safety profile consistent with prior Datroway studies.
TNBC accounts for about 15% of breast cancers, with roughly 345,000 global and 83,000 European diagnoses each year, and has poor outcomes, with only about 15% of patients with metastatic disease living five years after diagnosis. If ultimately approved, Datroway could become the first TROP2-directed antibody drug conjugate in the EU to show an overall survival benefit in this 1st-line TNBC setting.
AstraZeneca PLC officer Mani Sharma acquired 1 Ordinary Share as a compensation grant under the company’s Share Incentive Plan. The award was valued at $179.75 per share, based on a GBP134.54 price converted at a GBP1.0000 to $1.3360 rate. Following this grant, Sharma directly holds 19,263.4659 AstraZeneca Ordinary Shares.
AstraZeneca reported that the US FDA has approved Truqap (capivasertib) with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer, the first targeted therapy for this group. The approval is based on the Phase III CAPItello-281 trial, where the Truqap combination cut the risk of radiographic disease progression or death by 19% and extended median radiographic progression-free survival from 25.7 to 33.2 months. Overall survival data are still immature but numerically favor the Truqap arm. A companion diagnostic to detect PTEN deficiency in prostate tumors was approved at the same time, supporting biomarker-driven use of the regimen.
AstraZeneca PLC reported the admission of 14,120 additional ordinary shares of $0.25 each to trading on the Main Market of the London Stock Exchange. These shares were issued between 1 May 2026 and 31 May 2026 under the company’s employee share schemes and an existing block admission dated 29 January 2021.
Following this admission, the total number of AstraZeneca ordinary shares in issue is 1,551,009,750, which are fully fungible with the existing ordinary shares.