Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
Daily close, T-120 (6/30/25) through T+5. Run-up high $27.37 on 10/21/25, low $21.36 on 7/10/25 (T-120 to T-1). FDA decision 12/15/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-12-15
DrugEnhertu (trastuzumab deruxtecan) with pertuzumab - (DESTINY-Breast09)
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Enhertu (trastuzumab deruxtecan) with pertuzumab approved by the FDA?
Yes. The FDA approved the application for Enhertu (trastuzumab deruxtecan) with pertuzumab on December 15, 2025, per the FDA's own record. The primary source is linked on this page.
What was Enhertu (trastuzumab deruxtecan) with pertuzumab under FDA review for?
The application covered Early HER2+ Metastatic Breast Cancer. The FDA approved the application on December 15, 2025.
How did DSNKY stock react to the FDA decision?
On the decision day DSNKY moved +6.1%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.