AstraZeneca PLC
Saphnelo
systemic lupus erythematosus
Resolved
7days ago
FDA decision · ~ Jun 30, 2026 estimated
What's at stake
The FDA's approval decision on Saphnelo for systemic lupus erythematosus is due ~ Jun 30, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 6-K
verified 16h ago
“A decision from the FDA on the updated application for Saphnelo SC is expected in the first half of 2026.”