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Home › FDA Decisions › DSNKY 2025-01-27

DSNKY FDA Decision Approved · 2025-01-27

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 1/27/25$42.03$25.978/12/24
Daily close, T-120 (8/12/24) through T+5. Run-up high $42.03 on 9/6/24, low $25.97 on 1/13/25 (T-120 to T-1). FDA decision 1/27/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-01-27
DrugEnhertu - (DESTINY-Breast06)
IndicationHR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer
Outcome✓ Approvedprimary-sourced
Decision-day move+0.5%
T-120 run-up (low→high)+4.0% ($25.97→$33.9)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA761139, action date 2025-01-27
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 - (DESTINY-Breast06) approved by the FDA?

Yes. The FDA approved the application for Enhertu - (DESTINY-Breast06) on January 27, 2025. The primary source is linked on this page.

What was Enhertu - (DESTINY-Breast06) under FDA review for?

The application covered HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer. The FDA approved the application on January 27, 2025.

How did DSNKY stock react to the FDA decision?

On the decision day DSNKY moved +0.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.