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 reports that the US FDA has approved Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor, for adults with hypertension whose blood pressure remains uncontrolled on other medicines.
Approval is based on the Phase III BaxHTN trial in 796 patients, where Baxfendy 2mg lowered seated systolic blood pressure by 15.7 mmHg from baseline and 9.8 mmHg versus placebo at week 12. Both 2mg and 1mg doses showed statistically significant and clinically meaningful effects and were generally well tolerated. Baxfendy is also being studied in other aldosterone-driven cardiorenal conditions, supporting AstraZeneca’s broader cardiovascular, renal and metabolism portfolio.
AstraZeneca reports that the US FDA has approved Enhertu (trastuzumab deruxtecan), co-developed with Daiichi Sankyo, for two new HER2-positive early breast cancer uses in the neoadjuvant and adjuvant settings. These approvals move the drug into earlier, potentially curative stages of disease.
In DESTINY-Breast11, neoadjuvant Enhertu followed by THP achieved a pathologic complete response rate of 67.3% versus 56.3% with ddAC-THP, an 11.2% improvement. In DESTINY-Breast05, adjuvant Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1, with three-year invasive disease-free survival of 92.4% versus 83.7%.
No new overall safety concerns were seen, but drug-related interstitial lung disease/pneumonitis occurred in 9.6% of Enhertu patients versus 1.6% with T-DM1, including two Grade 5 events. Following these US approvals, AstraZeneca will pay Daiichi Sankyo $155 million in milestones, while US Enhertu sales are recognized by Daiichi Sankyo.
AstraZeneca reported positive interim Phase III VOLGA trial results for its immunotherapy Imfinzi in muscle-invasive bladder cancer. Perioperative Imfinzi plus neoadjuvant enfortumab vedotin significantly improved event-free and overall survival versus standard surgery in patients ineligible for or declining cisplatin-based chemotherapy.
A second regimen combining perioperative Imfinzi, Imjudo and neoadjuvant enfortumab vedotin delivered a significant event-free survival benefit and a favourable, though not yet statistically significant, overall survival trend. Safety was consistent with known profiles, with no new safety signals. AstraZeneca plans to present the data at a medical meeting and share them with global regulators, adding to an already broad set of Imfinzi indications across bladder, lung, liver and other cancers.
AstraZeneca PLC officer Sharma Mani reported routine share awards under the company’s Share Incentive Plan. On April 7, 2026, Mani acquired 1 Ordinary Share at $196.03, and on May 6, 2026, acquired 1 Ordinary Share at $186.28, both as grants rather than open-market purchases.
After these awards, Mani directly held a total of 31,155.4659 Ordinary Shares. The award prices reflect conversions from GBP148.06 and GBP136.76 using Federal Reserve exchange rates published in April and May 2026.
AstraZeneca PLC reported its updated share capital and voting rights position and confirmed the admission of a small number of new shares. As at 30 April 2026, the company has 1,550,995,630 ordinary shares of US$0.25 each in issue, all carrying voting rights and with no treasury shares held.
A further 14,807 ordinary shares were issued between 1 April 2026 and 30 April 2026 under AstraZeneca’s employee share schemes and admitted to trading on the London Stock Exchange’s Main Market under an existing block admission dated 29 January 2021. These new shares are fully fungible with existing ordinary shares.
AstraZeneca reported that the US FDA’s Oncologic Drugs Advisory Committee voted 3–6 against the benefit‑risk profile of camizestrant plus a CDK4/6 inhibitor as 1st‑line treatment for HR‑positive, HER2‑negative advanced breast cancer with emergent ESR1 mutations, based on the Phase III SERENA‑6 trial. The FDA had previously granted Breakthrough Therapy Designation and accepted the New Drug Application, and it is not bound by the committee’s advice. Despite the mixed vote, AstraZeneca highlighted SERENA‑6 data showing a 56% reduction in risk of progression or death versus aromatase inhibitor plus CDK4/6 inhibitor (hazard ratio 0.44), with median progression‑free survival of 16.0 months versus 9.2 months and additional benefits in second progression and patient‑reported quality‑of‑life measures. The company will continue working with the FDA as the review proceeds and is also pursuing regulatory reviews in the EU, Japan and other countries.
AstraZeneca reported that the FDA’s Oncologic Drugs Advisory Committee recommended its AKT inhibitor Truqap (capivasertib) plus abiraterone and androgen deprivation therapy for adults with PTEN-deficient metastatic hormone-sensitive prostate cancer, based on Phase III CAPItello-281 data. The Committee voted 7 in favour, 1 against and 1 abstention, citing a favourable benefit‑risk profile.
CAPItello‑281 showed a statistically significant 19% reduction in the risk of radiographic disease progression or death, with median radiographic progression‑free survival of 33.2 months for the Truqap combination versus 25.7 months for abiraterone and androgen deprivation therapy with placebo. Grade 3 or higher adverse events occurred in 67% of patients on the Truqap regimen versus 40.4% in the control arm, with rash, hyperglycaemia and hypokalaemia among the most common severe events.
The filing notes that Truqap would be the first targeted treatment option for this aggressive PTEN‑deficient subtype if approved. The FDA is not bound by the advisory vote and will continue reviewing the supplemental New Drug Application.
AstraZeneca PLC reported strong Q1 2026 results with broad-based growth and reaffirmed guidance. Total Revenue rose to $15,288m, up 13% at actual rates and 8% at constant exchange rates, driven by Oncology and Rare Disease medicines. Product Revenue reached $15,211m, with Oncology contributing $6,798m and Rare Disease $2,420m.
Reported EPS increased to $1.99 (up 6% actual, 8% CER) and Core EPS to $2.58 (up 4% actual, 5% CER), while Core Operating profit grew 12%. The Core Tax rate was 21%, and full-year Core Tax guidance remains 18–22%. AstraZeneca reconfirmed 2026 guidance for mid-to-high single-digit Total Revenue growth and low double-digit Core EPS growth at CER.
The company continued heavy R&D and business development investment, including a $100m upfront payment to Jacobio Pharma, a $25m option payment to Pinetree Therapeutics, and closing a strategic obesity and diabetes collaboration with CSPC Pharmaceuticals with a $1.2bn upfront payment and up to $3.5bn in potential milestones.
AstraZeneca PLC reported strong Q1 2026 results with broad-based growth and reaffirmed guidance. Total Revenue rose to $15,288m, up 13% at actual rates and 8% at constant exchange rates, driven by Oncology and Rare Disease medicines. Product Revenue reached $15,211m, with Oncology contributing $6,798m and Rare Disease $2,420m.
Reported EPS increased to $1.99 (up 6% actual, 8% CER) and Core EPS to $2.58 (up 4% actual, 5% CER), while Core Operating profit grew 12%. The Core Tax rate was 21%, and full-year Core Tax guidance remains 18–22%. AstraZeneca reconfirmed 2026 guidance for mid-to-high single-digit Total Revenue growth and low double-digit Core EPS growth at CER.
The company continued heavy R&D and business development investment, including a $100m upfront payment to Jacobio Pharma, a $25m option payment to Pinetree Therapeutics, and closing a strategic obesity and diabetes collaboration with CSPC Pharmaceuticals with a $1.2bn upfront payment and up to $3.5bn in potential milestones.
AstraZeneca PLC reports that Vanguard Capital Management beneficially owned 77,965,099 shares of Common Stock, representing 5.02% of the class as of 03/31/2026. The filing states Vanguard exercises sole voting power over 32,924,957 shares and sole dispositive power over 77,965,099 shares, and notes these holdings reflect positions held on behalf of Vanguard funds and managed accounts.
AstraZeneca reports that the US FDA has approved Breztri Aerosphere as the first and only fixed‑dose triple maintenance therapy for asthma in patients aged 12 and older. Breztri, already used in COPD, combines an inhaled corticosteroid, a long‑acting beta2‑agonist and a long‑acting muscarinic antagonist in a single inhaler.
The approval is based on the Phase III KALOS and LOGOS trials, which showed statistically significant and clinically meaningful improvements in lung function versus dual ICS/LABA therapy, with rapid improvement within five minutes after the first dose. Breztri is a maintenance treatment and does not replace a rescue inhaler.
Asthma affects about 27 million people in the US, and many remain uncontrolled on dual therapies. Breztri is already approved for COPD in 90 countries and was prescribed to more than 6.8 million patients globally in 2025. Regulatory filings for asthma are under review in other major regions including the EU, Japan and China.