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Home › FDA Decisions › CSLLY 2025-06-17

CSLLY FDA Decision Approved · 2025-06-17

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 6/17/25$44.79$36.42512/31/24
Daily close, T-120 (12/31/24) through T+5. Run-up high $44.79 on 1/15/25, low $36.425 on 4/10/25 (T-120 to T-1). FDA decision 6/17/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-06-17
DrugGaradacimab (CSL312)
IndicationHereditary angioedema (HAE)
Outcome✓ Approvedprimary-sourced
Decision-day move-0.9%
T-120 run-up (low→high)+4.0% ($36.35→$41.91)
ValidationVerified 2026-08-12: Drugs@FDA, application BLA761367, action date 2025-06-16
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 Garadacimab (CSL312) approved by the FDA?

Yes. The FDA approved the application for Garadacimab (CSL312) on June 17, 2025. The primary source is linked on this page.

What was Garadacimab (CSL312) under FDA review for?

The application covered Hereditary angioedema (HAE). The FDA approved the application on June 17, 2025.

How did CSLLY stock react to the FDA decision?

On the decision day CSLLY moved -0.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.