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Home › FDA Decisions › HOTH 2025-06-16

HOTH FDA Decision Approved · 2025-06-16

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 6/16/25$2.28$0.692512/30/24
Daily close, T-120 (12/30/24) through T+5. Run-up high $2.28 on 1/14/25, low $0.6925 on 4/10/25 (T-120 to T-1). FDA decision 6/16/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-06-16
DrugAndembry (garadacimab-gxii)
IndicationHereditary angioedema prophylaxis
Outcome✓ Approvedprimary-sourced
Decision-day move+0.8%
T-120 run-up (low→high)+42.0% ($0.69→$1.53)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA761367, action date 2025-06-16
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=117)

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 Andembry (garadacimab-gxii) approved by the FDA?

Yes. The FDA approved the application for Andembry (garadacimab-gxii) on June 16, 2025. The primary source is linked on this page.

What was Andembry (garadacimab-gxii) under FDA review for?

The application covered Hereditary angioedema prophylaxis. The FDA approved the application on June 16, 2025.

How did HOTH stock react to the FDA decision?

On the decision day HOTH moved +0.8%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.