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ASTRAZENECA PLC (AZN) SEC Filings, Aug-Sep 2026

AZN NYSE

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.

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AstraZeneca PLC (AZN) reports that the European Commission has approved Enhertu (trastuzumab deruxtecan) in combination with pertuzumab as a 1st‑line treatment for adult patients with unresectable or metastatic HER2‑positive breast cancer. This is the first new 1st‑line regimen in more than a decade for this setting in the EU.

The approval is based on the Phase III DESTINY‑Breast09 trial, where Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus taxane, trastuzumab and pertuzumab (THP), with a hazard ratio of 0.56. Median progression‑free survival was 40.7 months with the Enhertu combination compared with 26.9 months for THP, as assessed by blinded independent central review, with a safety profile consistent with known effects of the individual drugs.

The regimen has been included in the ESMO Clinical Practice Guidelines as a 1st‑line option for metastatic HER2‑positive breast cancer, regardless of hormone receptor status. Following this EU approval, AstraZeneca will pay Daiichi Sankyo a $100 million milestone related to the 1st‑line HER2‑positive metastatic breast cancer indication, while sales of Enhertu in most EU territories are recognised by Daiichi Sankyo.

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AstraZeneca PLC (AZN) has appointed Wan Ling Martello as a Non-Executive Director with effect from 1 September 2026. She will also join the company’s Audit Committee on her appointment. The Board highlights her extensive international executive and board experience across consumer products, retail and technology-enabled business models.

Martello is a founding partner of private equity firm BayPine and serves as an Independent Director of Alibaba Group and Director of The Lovesac Company. Her previous senior roles include global CFO and later CEO of Nestlé’s Asia, Oceania and Sub-Saharan Africa business, along with leadership positions at Walmart and other consumer companies. AstraZeneca states that, aside from the information disclosed, no further UK Financial Conduct Authority Listing Rules disclosures are required regarding her appointment.

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ASTRAZENECA PLC (AZN) has completed an exclusive global license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), an oral irreversible EGFR inhibitor for lung cancer. AstraZeneca has acquired worldwide rights to develop and commercialise the medicine.

Zegfrovy is already approved in the US and China for 2nd-line treatment of locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, a group with a real-world five-year overall survival rate as low as 8%. AstraZeneca plans a US launch in 4Q 2026 for this indication.

A supplemental New Drug Application for 1st-line NSCLC has been accepted by the US FDA and a similar filing submitted to China’s CDE, both with Breakthrough Therapy Designation. AstraZeneca will pay Dizal a $600m upfront, up to $900m in milestones, plus tiered royalties. The company states this transaction does not impact its 2026 financial guidance.

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AstraZeneca PLC (AZN) reported positive top-line results from the Phase III SANOVO trial in China, where the all-oral combination of Tagrisso (osimertinib) plus Orpathys (savolitinib) showed a statistically significant and highly clinically meaningful improvement in progression-free survival versus Tagrisso alone in 1st-line treatment of MET-overexpressing EGFR-mutated locally advanced or metastatic non-small cell lung cancer.

The progression-free survival benefit was seen in both high MET (IHC 3+) and intention-to-treat populations, with encouraging overall survival signals as a secondary endpoint. The safety profile of the combination was consistent with known profiles of each medicine, with no new safety findings. Data will be presented at an upcoming medical meeting and shared with regulators, supporting Tagrisso as a backbone therapy across EGFRm lung cancer and further validating the Tagrisso–Orpathys combination strategy.

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AstraZeneca PLC (AZN) announced positive high-level results from the Phase III CROSSING trial of Tezspire (tezepelumab) in eosinophilic esophagitis (EoE). In 368 adults and adolescents with symptomatic, uncontrolled EoE, Tezspire met both co-primary endpoints versus placebo at week 24 and maintained improvements through week 52 at both doses tested.

The co-primary endpoints were histologic remission and reduction in the frequency and severity of dysphagia, measured by the Dysphagia Symptom Questionnaire. Key secondary endpoints, including endoscopic and histologic measures at weeks 24 and 52, also showed benefit. The safety profile was generally consistent with Tezspire’s approved indications.

Tezspire, a first-in-class monoclonal antibody targeting thymic stromal lymphopoietin, is already approved for severe asthma and chronic rhinosinusitis with nasal polyps in multiple regions and has U.S. Orphan Drug Designation for EoE. AstraZeneca and Amgen plan to share full CROSSING data with regulators and at a future medical meeting.

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AstraZeneca PLC (AZN) reports that its wholly owned subsidiary AstraZeneca Finance LLC has priced a €2.55 billion Eurobond offering as part of its long term funding strategy. The offering, expected to close on 1 September 2026 subject to customary conditions, comprises four tranches of fixed rate notes fully and unconditionally guaranteed by AstraZeneca PLC.

The tranches include €700 million notes with a 3.402% coupon maturing 1 March 2030, €600 million notes with a 3.652% coupon maturing 1 September 2032, €500 million notes with a 3.923% coupon maturing 1 September 2035, and €750 million notes with a 4.169% coupon maturing 1 September 2038.

AstraZeneca expects to use the net proceeds for general corporate purposes. The notes will be issued under the Company’s Euro Medium Term Note programme and admitted to listing on the UK Financial Conduct Authority’s Official List and to trading on the London Stock Exchange’s Main Market. Barclays Bank PLC, Goldman Sachs International and Morgan Stanley acted as joint book-running managers.

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ASTRAZENECA PLC (AZN) reports that an award of ordinary shares under the AstraZeneca Performance Share Plan (AZPSP) vested to its Chief Financial Officer, Dr Aradhana Sarin, on 17 August 2026. The award was originally granted on 13 August 2021 and was subject to scientific, commercial and financial performance conditions assessed over a three-year period, followed by a two-year holding period before vesting.

Following dividend reinvestment and withholding of shares to meet tax obligations, Dr Sarin acquired 11,133 ordinary shares of US$0.25 each for nil consideration. For tax purposes, the fair market value at vesting was £114.60 per share, based on the closing price on the last trading day before vesting. The transaction is reported as an acquisition of shares pursuant to a plan vesting, conducted outside a trading venue, and is Dr Sarin’s first Performance Share Plan award to vest since becoming CFO in 2021.

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AstraZeneca (AZN) reported positive top-line results from the Phase III DESTINY-Lung04 trial of Enhertu (trastuzumab deruxtecan) in first-line treatment of patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous non-small cell lung cancer. Enhertu showed a statistically significant and clinically meaningful improvement in progression-free survival versus the global standard of care regimen of platinum-pemetrexed chemotherapy plus pembrolizumab. The study enrolled 454 patients randomised 1:1 to Enhertu or standard of care and will continue to assess secondary endpoints including overall survival and response outcomes. The safety profile was generally consistent with prior experience, with no new safety concerns identified. AstraZeneca and Daiichi Sankyo plan to present the data at a future medical meeting and share them with global regulatory authorities, supporting the potential to move Enhertu into the first-line setting for this molecularly defined NSCLC population.

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AstraZeneca PLC reported that it is discontinuing the Phase III eVOLVE-Lung02 trial of volrustomig plus chemotherapy as 1st-line treatment for metastatic non-small cell lung cancer with PD-L1 <50%. An Independent Data Monitoring Committee concluded the regimen was unlikely to meet the dual primary endpoints of progression-free survival and overall survival in patients with PD-L1 <1% compared with pembrolizumab plus chemotherapy. The safety profile was consistent with the known profiles of the individual medicines and no new safety signals were identified. AstraZeneca states that other Phase III volrustomig trials in cervical cancer, head and neck squamous cell carcinoma and mesothelioma continue as planned.

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AstraZeneca PLC reported positive high-level results from the global Phase III SAFFRON trial in patients with EGFR-mutated non-small cell lung cancer whose disease progressed on Tagrisso and whose tumours showed high MET overexpression or amplification. The combination of Tagrisso (osimertinib) plus Orpathys (savolitinib) delivered a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival versus doublet platinum-based chemotherapy, with a safety profile consistent with the known profiles of each drug and no new safety findings.

The SAFFRON trial randomised 338 patients across 230 centres in 29 countries, using Orpathys 300mg twice daily plus Tagrisso 80mg once daily. AstraZeneca and partner HUTCHMED intend to present the data at an upcoming medical meeting and to share them with global regulatory authorities, supporting potential wider registrations of the Tagrisso–Orpathys combination beyond existing approvals in China and a temporary authorisation in Switzerland.

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FAQ

How many ASTRAZENECA PLC (AZN) SEC filings are available on StockTitan?

StockTitan tracks 155 SEC filings for ASTRAZENECA PLC (AZN), including 10-K annual reports, 10-Q quarterly reports, 8-K current reports, and Form 4 insider trading disclosures. Each filing includes AI-generated summaries, impact scoring, and sentiment analysis.

When was the most recent SEC filing for ASTRAZENECA PLC (AZN)?

The most recent SEC filing for ASTRAZENECA PLC (AZN) was filed on September 1, 2026.