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Home › FDA Decisions › DSNKY 2025-01-27

DSNKY FDA Decision Approved · 2025-01-27

Page updated ·next FDA decision on the calendar ·Data as of Oct 14, 2026 7:39 PM ET

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 →

Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.

Questions

Was Enhertu approved by the FDA?

Yes. The FDA approved the application for Enhertu on January 27, 2025, per the FDA's own record. The primary source is linked on this page.

What was Enhertu 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.