Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
ENHERTU (trastuzumab deruxtecan) was approved by the FDA for High-Risk HER2 Positive Early-Stage Breast Cancer; the approval was announced on May 15, 2026.
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.
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Questions
Was ENHERTU (trastuzumab deruxtecan) approved by the FDA?
Yes. The approval of the application for ENHERTU (trastuzumab deruxtecan) was announced on May 15, 2026; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
Which company is behind ENHERTU (trastuzumab deruxtecan)?
ENHERTU (trastuzumab deruxtecan) is an AstraZeneca PLC (AZN) program. The company announced the FDA decision on May 15, 2026; the primary source 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.
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