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Home › FDA Decisions › DSNKY 2025-12-15

DSNKY FDA Decision Approved · 2025-12-15

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 12/15/25$27.37$21.366/30/25
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)
IndicationEarly HER2+ Metastatic Breast Cancer
Outcome✓ Approvedprimary-sourced
Decision-day move+6.1%
T-120 run-up (low→high)+12.0% ($21.4→$27.37)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA761139, action date 2025-12-15
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=280)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

See the full 2026 PDUFA calendar →

Questions

Was Enhertu (trastuzumab deruxtecan) with pertuzumab - (DESTINY-Breast09) approved by the FDA?

Yes. The FDA approved the application for Enhertu (trastuzumab deruxtecan) with pertuzumab - (DESTINY-Breast09) on December 15, 2025. The primary source is linked on this page.

What was Enhertu (trastuzumab deruxtecan) with pertuzumab - (DESTINY-Breast09) 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.