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 reports that the US Food and Drug Administration approved Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration combination for adults with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma in the 1st-line setting.
The 14‑month regimen is supported by the Phase III AMPLIFY trial, where 77% of patients on Calquence plus venetoclax were progression free at three years versus 67% on standard chemoimmunotherapy, and the combo reduced the risk of disease progression or death by 35% (hazard ratio 0.65).
Median progression-free survival was not reached for the Calquence combination versus 47.6 months for chemoimmunotherapy, and safety was consistent with the known Calquence profile without new safety signals.
AstraZeneca PLC reported strong full-year 2025 results with broad-based growth. Total Revenue rose to $58,739m, up 8% at constant exchange rates, led by Oncology, BioPharmaceuticals and Rare Disease. Reported EPS increased to $6.60, up 43% at constant exchange rates, while Core EPS grew 11% to $9.16.
The company highlighted 16 positive Phase 3 readouts and 43 major approvals over the last 12 months and now counts 16 blockbuster medicines. A total dividend of $3.20 per share for 2025 was declared, up 3%, with an intended increase to $3.30 per share in 2026.
For 2026, AstraZeneca guides to mid‑to‑high single‑digit Total Revenue growth and low double‑digit Core EPS growth at constant exchange rates, with a Core tax rate of 18–22%. The company also began trading ordinary shares on the NYSE, announced $15bn of planned investment in China through 2030, and signed major pipeline and collaboration deals, including a $1.2bn upfront weight‑management portfolio agreement with CSPC and sizeable oncology transactions with Jacobio Pharma and AbelZeta.
AstraZeneca PLC, through its wholly owned subsidiary Alexion Pharmaceuticals, Inc., has filed Amendment No. 1 to a Schedule 13G reporting its beneficial ownership in Monopar Therapeutics Inc. common stock.
The filing states that Alexion directly holds 522,667 shares of Monopar common stock, representing 7.8% of the outstanding shares, based on 6,682,584 shares outstanding as of October 31, 2025, as reported in Monopar’s Form 10-Q. AstraZeneca PLC and Alexion may each be deemed to have sole voting and sole dispositive power over these shares.
The reporting persons certify that the securities were not acquired and are not held for the purpose of changing or influencing control of Monopar, and are not held in connection with any transaction having that purpose or effect.
Innate Pharma SA filed an amended ownership report showing that AstraZeneca PLC and its wholly owned subsidiary MedImmune Limited together beneficially own 7,825,501 Ordinary Shares, including 1,565,001 shares represented by ADSs. This stake represents 8.3% of Innate Pharma’s Ordinary Shares, based on 93,719,323 shares outstanding as of December 31, 2025, as disclosed in a recent Form 6-K. AstraZeneca PLC and MedImmune Limited are each deemed to have sole voting and dispositive power over all shares held by MedImmune Limited, and neither the reporting entities nor their listed directors and officers have traded Innate Pharma shares in the past 60 days.
AstraZeneca reports that the US FDA issued a complete response letter for the Biologics License Application for subcutaneous Saphnelo in adults with systemic lupus erythematosus, but the company has submitted additional information and expects an FDA decision in the first half of 2026.
The subcutaneous form is supported by the Phase III TULIP-SC trial, which met its primary endpoint of reducing disease activity with a safety profile consistent with the approved IV formulation. Subcutaneous Saphnelo is already approved in the European Union for adults with moderate to severe lupus.
Saphnelo IV is approved in more than 70 countries, and more than 40,000 patients have been treated globally. Under an updated 2025 agreement, AstraZeneca will pay Bristol-Myers Squibb a mid-teens royalty on US Saphnelo sales.
AstraZeneca PLC reports its updated share capital and voting rights position. As at 31 January 2026, the company has 1,550,944,612 ordinary shares of US$0.25 in issue, all with voting rights and none held in treasury, giving the same total number of voting rights.
This figure is provided so shareholders can use it as the denominator when calculating whether they must notify their holdings or changes in holdings under the UK Financial Conduct Authority’s Disclosure and Transparency Rules.
AstraZeneca reports that its immunotherapy Imfinzi (durvalumab), combined with standard FLOT chemotherapy, has been recommended for EU approval as a perioperative treatment for adults with resectable Stage II-IVA gastric and gastroesophageal junction cancers. The regimen includes Imfinzi plus chemotherapy before surgery, followed by Imfinzi plus chemotherapy and then Imfinzi alone.
The CHMP’s positive opinion is based on the Phase III MATTERHORN trial, where the Imfinzi-based regimen cut the risk of disease progression, recurrence or death by 29% and reduced the risk of death by 22% versus chemotherapy alone. One- and two-year event-free survival rates and three‑year overall survival rates favored Imfinzi, with an overall survival benefit seen regardless of PD‑L1 status. Safety was similar between treatment arms, and surgery completion rates were comparable.
Imfinzi is already approved in this indication in the US and other countries based on MATTERHORN, and regulatory applications are under review in Japan and several additional markets. The decision positions Imfinzi as a potential first immunotherapy-based perioperative option for early gastric and GEJ cancers in the EU.
AstraZeneca PLC has begun trading its ordinary shares on the New York Stock Exchange, creating a harmonised global listing alongside its existing listings on the London Stock Exchange and Nasdaq Stockholm under the same AZN ticker. The company states this move opens access to the world’s largest capital market and broadens its global investor base.
Management highlights strong recent growth, citing pipeline readouts representing a stated peak revenue opportunity of over $10 billion and reiterating confidence in reaching a 2030 ambition of $80 billion in annual revenue and launching 20 new medicines. AstraZeneca’s UK and Swedish listings and index memberships remain unchanged, while its prior American Depositary Share listing ceased as ordinary share trading on the NYSE commenced, and its US dollar bonds are also transitioning to trade on the NYSE.
AstraZeneca PLC and AstraZeneca Finance LLC have filed Form 25 to voluntarily remove multiple securities from listing and registration on The Nasdaq Stock Market. The filing covers AstraZeneca American Depositary Shares representing one half of an ordinary share of 25¢ each, the underlying ordinary shares, and a wide range of AstraZeneca and AstraZeneca Finance senior notes with maturities from 2026 through 2051, many of which carry guarantees by AstraZeneca PLC. The companies certify they have complied with Nasdaq’s rules and the requirements of SEC Rule 12d2-2(c) for voluntary withdrawal, and the notification is signed by AstraZeneca PLC’s Company Secretary and an AstraZeneca Finance LLC Director on January 30, 2026.
AstraZeneca has entered a major collaboration with CSPC Pharmaceuticals to expand its weight management portfolio for obesity and type 2 diabetes across eight programmes. The deal gives AstraZeneca exclusive rights outside China to CSPC’s once-monthly injectable weight management portfolio, including clinical-ready GLP1R/GIPR agonist SYH2082 and three preclinical assets.
CSPC will receive an upfront payment of $1.2 billion, and is eligible for up to $3.5 billion in development and regulatory milestones, plus additional commercial milestones and tiered royalties. CSPC will lead development of four programmes through Phase I, after which AstraZeneca will take over development and commercialisation outside China. CSPC retains rights in China, Taiwan, Hong Kong and Macau, with an option for AstraZeneca to co-commercialise after approval. The transaction is expected to close in the second quarter of 2026, subject to customary conditions and regulatory clearances.