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Home › FDA Decisions › INTE 2025-03-28

INTE FDA Decision Approved · 2025-03-28

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 3/28/25$11.5$10.6110/11/24
Daily close, T-120 (10/11/24) through T+5. Run-up high $11.5 on 12/16/24, low $10.61 on 3/12/25 (T-120 to T-1). FDA decision 3/28/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-03-28
DrugQfitlia (fitusiran)
IndicationHemophilia A or B bleeding prevention
Outcome✓ Approvedprimary-sourced
Decision-day move+0.0%
T-120 run-up (low→high)+5.0% ($10.61→$11.5)
ValidationVerified 2026-08-12: Drugs@FDA, application NDA219019, action date 2025-03-28
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

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 Qfitlia (fitusiran) approved by the FDA?

Yes. The FDA approved the application for Qfitlia (fitusiran) on March 28, 2025. The primary source is linked on this page.

What was Qfitlia (fitusiran) under FDA review for?

The application covered Hemophilia A or B bleeding prevention. The FDA approved the application on March 28, 2025.

How did INTE stock react to the FDA decision?

On the decision day INTE moved +0.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.