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AZN FDA decision: Apr 27, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

AstraZeneca PLC: SAPHNELO (anifrolumab-fnia) · Systemic lupus erythematosus (SLE).

Run-up into the decision (T-120 → T+5)

PDUFA 4/27/26$209.48$162.311/10/25
Daily close, T-120 (11/10/25) through T+5. Run-up high $209.48 on 2/18/26, low $162.3 on 11/13/25 (T-120 to T-1). FDA decision 4/27/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-27
OutcomeApproved
Drug / candidateSAPHNELO (anifrolumab-fnia)
CompanyAstraZeneca PLC
120-day run-up (T-120→T-1)+15.1%

Questions

Was SAPHNELO (anifrolumab-fnia) approved by the FDA?

Yes. The FDA approved the application for SAPHNELO (anifrolumab-fnia) on April 27, 2026. The primary source is linked on this page.

Which company is behind SAPHNELO (anifrolumab-fnia)?

SAPHNELO (anifrolumab-fnia) is a AstraZeneca PLC (AZN) program. The FDA decision came on April 27, 2026; the company's own announcement is linked on this page.

How did AZN stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), AZN moved +15.1%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.