AstraZeneca's Saphnelo Injection Faces FDA Rejection, Shares Drop 1.9%
ByAinvest
Tuesday, Feb 3, 2026 11:55 am ET1min read
AZN--
AstraZeneca's shares fell 1.9% after the FDA declined approval for its lupus treatment, Saphnelo, in self-administered injection form. The regulator requested additional information, and AstraZeneca is working to progress the application. Saphnelo is already approved for intravenous therapy, and the subcutaneous version has EU approval. The FDA is expected to decide on the updated US application in the first half of this year.
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