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.
The AstraZeneca PLC (AZN) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as a foreign private issuer. AstraZeneca files under Form 20-F for its annual report and uses Form 6-K to furnish current reports on material developments. These filings cover a broad range of topics, including clinical trial data, regulatory approvals, manufacturing investments, insider share transactions and changes in major shareholdings.
For investors following AstraZeneca’s oncology franchise, 6-K exhibits often reproduce detailed press releases on medicines such as Enhertu (trastuzumab deruxtecan), Datroway (datopotamab deruxtecan) and Imfinzi (durvalumab). These documents describe Phase 3 trial designs and endpoints, Breakthrough Therapy Designations, new indications in breast, lung, gastric, endometrial and ovarian cancers, and approvals in key markets. They can help readers understand how specific trials, such as DESTINY-Breast, TROPION, MATTERHORN and others, relate to AstraZeneca’s pipeline and commercial portfolio.
Filings also address Rare Diseases and Respiratory & Immunology, including updates on Koselugo (selumetinib) for neurofibromatosis type 1 and Saphnelo (anifrolumab) for systemic lupus erythematosus. Additional 6-Ks report on large capital projects, such as multi‑billion‑dollar manufacturing investments in Maryland and other US states, and on governance matters like director and senior executive share dealings or notifications of major institutional holdings.
On Stock Titan, these AZN filings are supplemented with AI-powered summaries that explain the key points of each document in plain language. Users can quickly see which filings relate to new indications, safety information, insider transactions (similar to Form 4-style disclosures for US issuers) or strategic investments. Real-time updates from EDGAR ensure that new AstraZeneca 6-Ks and other SEC submissions appear promptly, while AI insights help readers navigate lengthy technical exhibits such as clinical trial descriptions and multi-indication product updates.
AstraZeneca PLC is reorganising its US market presence by completing a direct listing of its ordinary shares and US debt securities on the New York Stock Exchange. The move is part of a shareholder approved plan to create a harmonised listing structure that supports a single global listing framework for investors.
The company has given notice that its American Depositary Shares, which represent ordinary shares on a two-for-one basis, and certain debt securities currently listed on Nasdaq are expected to cease trading there on 30 January 2026. AstraZeneca’s ordinary shares and these debt securities are expected to begin trading on the NYSE on 2 February 2026 under the ticker symbol AZN. After these changes, investors will be able to trade ordinary share interests across the London Stock Exchange, Nasdaq Stockholm and the NYSE.
AstraZeneca PLC reports a leadership change in its investor relations function. The company has appointed Joris Silon as Head of Investor Relations, effective 1 March 2026, succeeding Andy Barnett. Joris moves into this role from his position as country president of AstraZeneca US, where he led and delivered significant growth in the company’s largest market, and he will be based in Cambridge, UK. He brings extensive pharmaceutical experience, having joined AstraZeneca in 2000 and held leadership roles across Asia, Europe and the US. Chief Financial Officer Aradhana Sarin highlighted his experience and thanked Andy Barnett for his leadership of the Investor Relations team over the past four years as he transitions to a new role within the company.
AstraZeneca reported that Enhertu (trastuzumab deruxtecan), developed with Daiichi Sankyo, has received US FDA Breakthrough Therapy Designation as a post‑neoadjuvant treatment for adults with HER2‑positive early breast cancer who have residual invasive disease after neoadjuvant therapy and are at high risk of recurrence. The designation is based on positive Phase III DESTINY‑Breast05 trial results, which were presented at the 2025 ESMO Congress and published in The New England Journal of Medicine. DESTINY‑Breast05 enrolled 1,635 patients and compares Enhertu to trastuzumab emtansine (T‑DM1), the current standard in this setting, using invasive disease‑free survival as the primary endpoint. This is the tenth Breakthrough Therapy Designation for Enhertu, reinforcing its strategic importance within AstraZeneca’s growing oncology and breast cancer portfolio.
AstraZeneca reported that Enhertu (trastuzumab deruxtecan), developed with Daiichi Sankyo, has received US FDA Breakthrough Therapy Designation as a post‑neoadjuvant treatment for adults with HER2‑positive early breast cancer who have residual invasive disease after neoadjuvant therapy and are at high risk of recurrence. The designation is based on positive Phase III DESTINY‑Breast05 trial results, which were presented at the 2025 ESMO Congress and published in The New England Journal of Medicine. DESTINY‑Breast05 enrolled 1,635 patients and compares Enhertu to trastuzumab emtansine (T‑DM1), the current standard in this setting, using invasive disease‑free survival as the primary endpoint. This is the tenth Breakthrough Therapy Designation for Enhertu, reinforcing its strategic importance within AstraZeneca’s growing oncology and breast cancer portfolio.
AstraZeneca reported that Enhertu (trastuzumab deruxtecan), developed with Daiichi Sankyo, has received US FDA Breakthrough Therapy Designation as a post‑neoadjuvant treatment for adults with HER2‑positive early breast cancer who have residual invasive disease after neoadjuvant therapy and are at high risk of recurrence. The designation is based on positive Phase III DESTINY‑Breast05 trial results, which were presented at the 2025 ESMO Congress and published in The New England Journal of Medicine. DESTINY‑Breast05 enrolled 1,635 patients and compares Enhertu to trastuzumab emtansine (T‑DM1), the current standard in this setting, using invasive disease‑free survival as the primary endpoint. This is the tenth Breakthrough Therapy Designation for Enhertu, reinforcing its strategic importance within AstraZeneca’s growing oncology and breast cancer portfolio.
AstraZeneca PLC disclosed a routine shareholding change involving a board member and his spouse. On 17 December 2025, Non-Executive Director and PDMR Philip Broadley gifted 5,735 ordinary shares of US$0.25 each in AstraZeneca to his spouse, Gillian Broadley, for no payment. The transfer was carried out outside a trading venue and is classified as a gift, with matching notifications filed for both the director (as the giver) and his spouse (as the recipient). This update is a standard regulatory disclosure of dealings by persons discharging managerial responsibilities and their closely associated persons, and does not change the total number of AstraZeneca shares outstanding.
AstraZeneca reports that the European Union has approved its lupus medicine Saphnelo (anifrolumab) for subcutaneous self-administration in a once-weekly 120mg pre-filled pen for adult patients with systemic lupus erythematosus receiving standard therapy. The decision follows a positive Phase III TULIP-SC trial, where subcutaneous Saphnelo produced a statistically significant and clinically meaningful reduction in disease activity versus placebo.
The new at-home option complements Saphnelo IV infusion, which is already approved for moderate to severe SLE in more than 70 countries and has been used by more than 40,000 patients globally. AstraZeneca highlights that about 70% of SLE patients on biologics in Europe use subcutaneous self-administration, so this route may help reach more patients while expanding treatment choice, with sales continuing to generate low to mid-teens royalties payable to Bristol-Myers Squibb.
AstraZeneca reports that Enhertu (trastuzumab deruxtecan) plus pertuzumab has been approved in the US as a 1st-line treatment for adults with unresectable or metastatic HER2-positive breast cancer, following Priority Review and Breakthrough Therapy Designation.
The approval is based on the Phase III DESTINY-Breast09 trial, where the combination reduced the risk of disease progression or death by 44% versus standard THP therapy and achieved a median progression-free survival of 40.7 months compared with 26.9 months for THP, with a safety profile consistent with the individual drugs.
This decision triggers a $150m milestone payment from AstraZeneca to Daiichi Sankyo for this 1st-line HER2-positive metastatic breast cancer indication, while US sales of Enhertu are recognised by Daiichi Sankyo.
AstraZeneca PLC reports that the US FDA has approved Imfinzi (durvalumab) in combination with FLOT chemotherapy as the first and only perioperative immunotherapy for adults with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction cancers. The regimen includes Imfinzi plus chemotherapy before surgery, followed by Imfinzi plus chemotherapy and then Imfinzi alone.
The approval is based on the Phase III MATTERHORN trial, where the Imfinzi-based perioperative regimen reduced the risk of disease progression, recurrence or death by 29% (EFS HR 0.71) versus chemotherapy alone, and reduced the risk of death by 22% (OS HR 0.78). An estimated 69% of patients on the Imfinzi regimen were alive at three years versus 62% with chemotherapy alone, with safety broadly consistent with known profiles. The submission was reviewed under Project Orbis and is also under review in multiple other countries and regions.
AstraZeneca PLC plans to invest $2 billion to expand its manufacturing footprint in Maryland, adding major capacity for cancer, rare and chronic disease medicines. The company will significantly expand its biologics facility in Frederick, nearly doubling commercial manufacturing capacity and supporting 200 new highly skilled jobs and 900 construction roles, with operations expected in 2029. A new clinical manufacturing facility in Gaithersburg will focus on development and clinical supply of innovative molecules, creating 100 new jobs, retaining 400 roles and supporting 1,000 construction-related jobs, and is also expected to be fully operational in 2029.
The investment supports a total of 2,600 jobs across the two Maryland sites and will, for the first time, bring production across AstraZeneca's rare disease portfolio onshore in the US. This is the fourth major US manufacturing investment announced this year and forms part of AstraZeneca's previously announced historic $50 billion commitment to medicines manufacturing and R&D.