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AstraZeneca ( (GB:AZN) ) just unveiled an announcement.
AstraZeneca has received a complete response letter from the US Food and Drug Administration for the biologics license application seeking approval of subcutaneous Saphnelo (anifrolumab) in adult patients with systemic lupus erythematosus, but has already submitted the requested additional information and expects a regulatory decision in the first half of 2026, while the currently approved intravenous formulation remains on the market. The submission is underpinned by positive Phase III TULIP-SC data showing that subcutaneous Saphnelo met its primary endpoint with a safety profile consistent with the IV form, following recent European Union approval for subcutaneous use; with more than 40,000 patients already treated globally and a royalty-bearing agreement with Bristol Myers Squibb in the US, the move to a more convenient administration route could strengthen AstraZeneca’s competitive position in lupus and broaden uptake if US approval is secured.
More about AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company based in Cambridge, UK, focused on the discovery, development and commercialisation of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. The company is an established leader in respiratory care with a growing portfolio of biologics and other therapies for immune-mediated and chronic respiratory diseases, and its medicines are sold in more than 125 countries and used by millions of patients worldwide.
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