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AZN FDA decision: May 15, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

AstraZeneca PLC, ENHERTU (trastuzumab deruxtecan) - (DESTINY- · High-Risk HER2 Positive Early-Stage Breast Cancer.

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

PDUFA 5/15/26$209.48$177.3611/28/25
Daily close, T-120 (11/28/25) through T+5. Run-up high $209.48 on 2/18/26, low $177.36 on 11/28/25 (T-120 to T-1). FDA decision 5/15/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-05-15
OutcomeApproved
Drug / candidateENHERTU (trastuzumab deruxtecan) - (DESTINY-
CompanyAstraZeneca PLC
120-day run-up (T-120→T-1)+4.3%

Questions

Was ENHERTU (trastuzumab deruxtecan) - (DESTINY- approved by the FDA?

Yes. The FDA approved the application for ENHERTU (trastuzumab deruxtecan) - (DESTINY- on May 15, 2026. The primary source is linked on this page.

Which company is behind ENHERTU (trastuzumab deruxtecan) - (DESTINY-?

ENHERTU (trastuzumab deruxtecan) - (DESTINY- is a AstraZeneca PLC (AZN) program. The FDA decision came on May 15, 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 +4.3%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.