Welcome to our dedicated page for AstraZeneca SEC filings (Ticker: AZNCF), 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 AZNCF SEC filings page on Stock Titan provides access to AstraZeneca PLC regulatory disclosures as furnished to the U.S. Securities and Exchange Commission. AstraZeneca uses Form 6-K reports to share information on clinical trial results, regulatory milestones and portfolio updates for its prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.
Recent 6-K filings show the depth of information available to investors and researchers. One report details the KOMET Phase III trial of Koselugo (selumetinib) in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas, supporting a positive opinion from the European Medicines Agency’s CHMP. Another filing summarises the WAYPOINT Phase III trial of Tezspire (tezepelumab) in chronic rhinosinusitis with nasal polyps, including co-primary endpoints on nasal polyp score and nasal congestion.
Additional 6-Ks provide high-level data from the TULIP-SC Phase III trial of Saphnelo (anifrolumab) in systemic lupus erythematosus and an update on the RESOLUTE Phase III trial of Fasenra (benralizumab) in chronic obstructive pulmonary disease. These documents also restate AstraZeneca’s standard company description, outlining its global footprint, therapeutic focus and Respiratory & Immunology franchise.
On Stock Titan, users can review these filings as they are made available from EDGAR and use AI-powered summaries to understand the key points of each document, such as trial design, primary and secondary endpoints, safety profiles and regulatory implications, without reading every technical detail.
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 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.
AstraZeneca plans to invest $15 billion in China through 2030 to expand medicines manufacturing and research and development. The company aims to strengthen capabilities in cell therapy and radioconjugates, supporting treatments for cancer, blood disorders, autoimmune diseases, and other conditions.
The investment will extend AstraZeneca’s China network from drug discovery and clinical development to large-scale production, building on existing R&D centers in Beijing and Shanghai and manufacturing sites in Wuxi, Taizhou, Qingdao, and Beijing. The company expects its highly skilled workforce in China to grow beyond 20,000, creating thousands of additional jobs across the healthcare ecosystem.
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 announced a CHMP positive opinion recommending Koselugo (selumetinib) for approval in the EU to treat symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1). The recommendation rests on KOMET, a global, placebo-controlled Phase III trial in 145 adults that reported a statistically significant objective response rate (ORR) of 20% with Koselugo versus 5% with placebo by cycle 16 (p=0.01). The safety profile in adults was consistent with prior paediatric experience. Koselugo is already approved for certain paediatric NF1 PN indications and has recent adult approvals in Japan and other countries; further regulatory reviews are ongoing.
AstraZeneca and Amgen's Tezspire (tezepelumab) received a positive CHMP recommendation for approval in the EU to treat adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The opinion was based on the Phase III WAYPOINT trial, which showed Tezspire reduced nasal polyp size by a mean of 2.08 points and nasal congestion by 1.04 points versus placebo at Week 52, with p<0.001 for both co-primary endpoints.
WAYPOINT data also reported a 98% near-elimination of the need for surgery and an 89% reduction in systemic corticosteroid use versus placebo. Safety and tolerability were consistent with the known profile. Regulatory reviews are ongoing in multiple other countries.
AstraZeneca reported positive interim Phase III results from the TULIP-SC trial showing subcutaneous Saphnelo (anifrolumab) met the pre-specified primary endpoint of reduced disease activity versus placebo in patients with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE). The reduction in disease activity was measured by the BICLA at week 52, which requires improvement across organs without new flares. The interim analysis included the first 220 participants reaching week 52 from a randomised 1:1 trial of 367 participants receiving 120mg subcutaneous anifrolumab once weekly versus placebo on top of standard therapy. Safety was consistent with the known IV profile. Results are under regulatory review and slated for presentation at ACR Convergence 2025.