AstraZeneca PLC's SEC filings document the disclosures of a foreign private issuer reporting on Form 6-K and Form 20-F. The filings include quarterly results, product sales, alliance revenue, collaboration revenue and segment-level operating commentary tied to areas such as Oncology, Rare Disease and respiratory medicines.
The filing record also includes regulatory and clinical exhibits for AstraZeneca medicines, including Breztri Aerosphere and Truqap, as well as notices on total voting rights, ordinary shares of US$0.25, admissions of further securities to trading, and UK disclosure-rule matters. These documents record capital structure, market-admission information, product approvals, clinical data updates and governance-related reporting obligations.
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 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 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 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 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 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 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.
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.
AstraZeneca reports that the US Food and Drug Administration has approved Saphnelo (anifrolumab) for subcutaneous self-administration via the once-weekly 120mg Saphnelo Pen autoinjector for adult patients with systemic lupus erythematosus on standard therapy.
The decision is based on the Phase III TULIP-SC trial, where subcutaneous Saphnelo produced a statistically significant and clinically meaningful reduction in disease activity versus placebo, with a safety profile consistent with the existing intravenous formulation. In secondary and exploratory endpoints, 29.0% of patients achieved DORIS remission and 40.1% reached low-level disease activity (LLDAS).
Saphnelo subcutaneous dosing is already approved in the EU and Japan, and more than 40,000 patients worldwide have been treated with Saphnelo. Under an updated agreement, AstraZeneca will pay Bristol-Myers Squibb a mid-teens royalty on US Saphnelo sales.
AstraZeneca reports that the US Food and Drug Administration has approved Saphnelo (anifrolumab) for subcutaneous self-administration via the once-weekly 120mg Saphnelo Pen autoinjector for adult patients with systemic lupus erythematosus on standard therapy.
The decision is based on the Phase III TULIP-SC trial, where subcutaneous Saphnelo produced a statistically significant and clinically meaningful reduction in disease activity versus placebo, with a safety profile consistent with the existing intravenous formulation. In secondary and exploratory endpoints, 29.0% of patients achieved DORIS remission and 40.1% reached low-level disease activity (LLDAS).
Saphnelo subcutaneous dosing is already approved in the EU and Japan, and more than 40,000 patients worldwide have been treated with Saphnelo. Under an updated agreement, AstraZeneca will pay Bristol-Myers Squibb a mid-teens royalty on US Saphnelo sales.
AstraZeneca PLC announced a change to its Board of Directors. Rene Haas will step down as a Non-Executive Director on 30 April 2026 as he assumes an additional role as Chief Executive Officer of SoftBank Group International alongside his position as CEO of Arm Holdings plc.
The company stated that, under section 430(2B) of the Companies Act 2006, Haas will receive only his non-executive director fees for his time on the Board and no payment for loss of office.
AstraZeneca PLC announced a change to its Board of Directors. Rene Haas will step down as a Non-Executive Director on 30 April 2026 as he assumes an additional role as Chief Executive Officer of SoftBank Group International alongside his position as CEO of Arm Holdings plc.
The company stated that, under section 430(2B) of the Companies Act 2006, Haas will receive only his non-executive director fees for his time on the Board and no payment for loss of office.
AstraZeneca reported positive interim Phase III results from the global I CAN trial of Ultomiris (ravulizumab) in adults with immunoglobulin A nephropathy (IgAN) at risk of disease progression. Ultomiris met the primary interim endpoint, showing a statistically significant and clinically meaningful reduction in proteinuria at week 34, with rapid effects seen as early as week 10.
The trial will continue to week 106 to assess change in estimated glomerular filtration rate (eGFR) and longer-term kidney outcomes. The safety profile was consistent with the known profile of Ultomiris, and AstraZeneca plans to seek accelerated approval in key markets and present full data at a medical meeting.
AstraZeneca reported positive interim Phase III results from the global I CAN trial of Ultomiris (ravulizumab) in adults with immunoglobulin A nephropathy (IgAN) at risk of disease progression. Ultomiris met the primary interim endpoint, showing a statistically significant and clinically meaningful reduction in proteinuria at week 34, with rapid effects seen as early as week 10.
The trial will continue to week 106 to assess change in estimated glomerular filtration rate (eGFR) and longer-term kidney outcomes. The safety profile was consistent with the known profile of Ultomiris, and AstraZeneca plans to seek accelerated approval in key markets and present full data at a medical meeting.
AstraZeneca reported that its IL-33-targeting biologic tozorakimab met the primary endpoint in the Phase III MIRANDA trial in chronic obstructive pulmonary disease (COPD). The drug produced a statistically significant and clinically meaningful reduction in the annualised rate of moderate-to-severe COPD exacerbations in former smokers and in the overall trial population.
This is the third positive pivotal Phase III trial for tozorakimab in COPD, following the OBERON and TITANIA studies, reinforcing evidence of benefit on top of standard inhaled therapies. Tozorakimab 300mg every two or four weeks was generally well tolerated with a favourable safety profile consistent with earlier trials, and the data will be submitted to regulatory authorities and shared at an upcoming medical meeting.
AstraZeneca reported that its IL-33-targeting biologic tozorakimab met the primary endpoint in the Phase III MIRANDA trial in chronic obstructive pulmonary disease (COPD). The drug produced a statistically significant and clinically meaningful reduction in the annualised rate of moderate-to-severe COPD exacerbations in former smokers and in the overall trial population.
This is the third positive pivotal Phase III trial for tozorakimab in COPD, following the OBERON and TITANIA studies, reinforcing evidence of benefit on top of standard inhaled therapies. Tozorakimab 300mg every two or four weeks was generally well tolerated with a favourable safety profile consistent with earlier trials, and the data will be submitted to regulatory authorities and shared at an upcoming medical meeting.