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 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.
AstraZeneca reported top-line results from the RESOLUTE Phase III trial of Fasenra (benralizumab) in COPD. The trial randomized 689 participants with moderate to very severe COPD, all on background ICS/LABA/LAMA therapy and with elevated blood eosinophils (≥300 cells/µL). The primary endpoint—annualised rate of moderate or severe exacerbations in patients with ≥3 prior-year exacerbations—showed a numerical improvement with Fasenra but did not reach statistical significance. Safety and tolerability were consistent with Fasenra's known profile. AstraZeneca said it will analyse the full data set and share results with the scientific community. Fasenra is already approved for severe eosinophilic asthma and other eosinophilic conditions in multiple countries.
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