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CSLLY FDA Decision Approved · 2025-06-17

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

Price into the decision (T-120)

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)3.7% median (n=302)

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 Garadacimab (CSL312) approved by the FDA?

Yes. The FDA approved the application for Garadacimab (CSL312) on June 16, 2025, per the FDA's own record. The company announced it 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.