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TAK FDA Decision Approved · 2025-06-30

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 6/30/25$15.39$12.891/13/25
Daily close, T-120 (1/13/25) through T+5. Run-up high $15.39 on 6/13/25, low $12.89 on 1/28/25 (T-120 to T-1). FDA decision 6/30/25. Historical price action, not a forecast.
Positioning before the decision
On Jun 16, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.3% through Jul 18, 2025 (the first listed expiry after the decision; ATM implied volatility 27%). The stock closed +2.4% at the first close across the decision and -0.2% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-06-30
DrugGAMMAGARD LIQUID ERC [Immune Globulin Infusion (Human) with less than or equal to 2 µg/mL
IndicationLow immunoglobulin A (IgA)
Outcome✓ Approvedprimary-sourced
Decision-day move+2.4%
T-120 run-up (low→high)+8.0% ($13.71→$15.46)
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=835)

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 GAMMAGARD LIQUID ERC [Immune Globulin Infusion (Human) with less than approved by the FDA?

Yes. The FDA approved the application for GAMMAGARD LIQUID ERC [Immune Globulin Infusion (Human) with less than on June 30, 2025. The primary source is linked on this page.

What was GAMMAGARD LIQUID ERC [Immune Globulin Infusion (Human) with less than under FDA review for?

The application covered Low immunoglobulin A (IgA). The FDA approved the application on June 30, 2025.

How did TAK stock react to the FDA decision?

On the decision day TAK moved +2.4%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.