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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 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.
AstraZeneca PLC has reported an updated share count for voting purposes. As at 31 May 2026, the company’s issued share capital with voting rights consists of 1,551,009,750 ordinary shares of US$0.25 each. The company holds no shares in treasury, so the total number of voting rights is also 1,551,009,750.
This figure is provided under the UK Financial Conduct Authority’s Disclosure and Transparency Rule 5.6.1 and is intended to help shareholders calculate whether they must notify AstraZeneca and regulators about their holdings or changes in their holdings.
AstraZeneca reports that the US FDA has approved Imfinzi (durvalumab) plus Bacillus Calmette-Guérin (BCG) as the first immunotherapy combination for adults with BCG-naïve, high-risk non-muscle-invasive bladder cancer. This early-stage setting targets patients at significant risk of recurrence and progression.
The approval is based on the Phase III POTOMAC trial, where adding one year of Imfinzi to BCG cut the risk of high-risk disease recurrence, progression or death by 32%, with a disease-free survival hazard ratio of 0.68. Median disease-free survival was not reached in either arm after more than five years of follow-up, and safety was consistent with the known profiles of Imfinzi and BCG.
Regulatory submissions using POTOMAC data are under review in the EU, Japan and other countries, while Imfinzi continues to be developed and approved across multiple lung, liver, biliary tract, gastric and endometrial cancer indications.
AstraZeneca PLC has voluntarily withdrawn the listing/registration of its 1.200% Notes due 2026 from the New York Stock Exchange via Form 25, with the Exchange certifying compliance with the applicable withdrawal rules.
AstraZeneca reports that the US FDA has extended the Prescription Drug User Fee Act (PDUFA) decision date for the New Drug Application for camizestrant combined with a CDK4/6 inhibitor as 1st-line treatment for HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutations, to review additional requested data from the Phase III SERENA-6 trial.
The company has submitted new analyses, including ctDNA clearance data linked to longer-term efficacy that will be presented at ASCO 2026. In contrast to the extended US timeline, the European Medicines Agency’s human medicines committee has issued a positive opinion recommending approval, and camizestrant is already approved in this setting in the UAE and Saudi Arabia, with further regulatory reviews ongoing in Japan and other countries.
AstraZeneca PLC reports that Datroway (datopotamab deruxtecan), co-developed with Daiichi Sankyo, has been approved in the US for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval, granted after Priority Review, is based on the Phase III TROPION-Breast02 trial, where Datroway improved median overall survival by 5.0 months versus chemotherapy, with a hazard ratio of 0.79. Datroway also reduced the risk of disease progression or death by 43% and achieved a 64% objective response rate compared with 30% for chemotherapy. The medicine is now approved for three indications in the US and is included as a Category 1 Preferred 1st-line option in the NCCN Guidelines for this TNBC population. Global regulatory reviews and an extensive development programme across multiple cancers are ongoing.
AstraZeneca reported that the European Medicines Agency’s CHMP has recommended Enhertu (trastuzumab deruxtecan), co-developed with Daiichi Sankyo, for approval in the EU as a monotherapy for adults with unresectable or metastatic HER2‑positive (IHC 3+) solid tumours who have received prior treatment and lack satisfactory options.
This proposed tumour‑agnostic indication is supported by three Phase II trials. In DESTINY‑PanTumor02, Enhertu achieved a confirmed objective response rate of 51.4% and a median duration of response of 14.2 months in 111 patients with IHC 3+ solid tumours, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and other cancers. DESTINY‑Lung01 showed a 52.9% response rate and 6.9‑month median response in 17 patients with IHC 3+ non‑small cell lung cancer, while DESTINY‑CRC02 reported a 46.9% response rate and 5.5‑month median response in 64 patients with IHC 3+ colorectal cancer. The safety profile was consistent with earlier studies, with no new concerns identified.
AstraZeneca reports that the EU’s CHMP has issued a positive opinion recommending approval of camizestrant, an investigational next‑generation oral SERD, in combination with a CDK4/6 inhibitor as 1st‑line treatment for ER‑positive, HER2‑negative locally advanced or metastatic breast cancer with an emergent ESR1 mutation.
The recommendation is based on the Phase III SERENA‑6 trial, where the camizestrant combination cut the risk of disease progression or death by 56% versus an aromatase inhibitor plus CDK4/6 inhibitor, improving median progression‑free survival to 16.0 months from 9.2 months. A later analysis showed a statistically significant improvement in time to second progression and maturing overall‑survival data trending in favour of camizestrant. Safety was consistent with known profiles of the component drugs.
Camizestrant is already approved in the UAE and Saudi Arabia in this setting, and regulatory applications are under review in the US, Japan and other countries, underscoring AstraZeneca’s broader strategy in HR‑positive breast cancer and its expanding oncology portfolio.
ASTRAZENECA PLC officer Sharma Mani reported an open-market sale of 11,893 Ordinary Shares on May 20, 2026 at an average price of $185.78 per share, based on a GBP139.35 price and a stated currency conversion rate. After this transaction, Mani directly holds 19,262.4659 Ordinary Shares.
ASTRAZENECA PLC officer Sharma Mani reported an open-market sale of 11,893 Ordinary Shares on May 20, 2026 at an average price of $185.78 per share, based on a GBP139.35 price and a stated currency conversion rate. After this transaction, Mani directly holds 19,262.4659 Ordinary Shares.
ASTRAZENECA PLC officer Sharma Mani reported an open-market sale of 11,893 Ordinary Shares on May 20, 2026 at an average price of $185.78 per share, based on a GBP139.35 price and a stated currency conversion rate. After this transaction, Mani directly holds 19,262.4659 Ordinary Shares.
ASTRAZENECA PLC officer Sharma Mani reported an open-market sale of 11,893 Ordinary Shares on May 20, 2026 at an average price of $185.78 per share, based on a GBP139.35 price and a stated currency conversion rate. After this transaction, Mani directly holds 19,262.4659 Ordinary Shares.
AstraZeneca PLC reported that an award of ordinary shares under the AstraZeneca Performance Share Plan vested to Chief Executive Officer Pascal Soriot on 14 May 2026. The award, originally granted on 14 May 2021, was subject to performance measures over three years followed by a two-year holding period.
Application of these performance measures resulted in 88% of the award vesting, with the remainder lapsing. After dividend reinvestment and tax withholding, Mr Soriot acquired 18,359 ordinary shares for nil consideration, changing his beneficial interests in AstraZeneca shares. The fair market value at vest for tax purposes was 13,766 pence per share.