Page updated ·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 (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
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was GAMMAGARD LIQUID ERC [Immune Globulin Infusion (Human) with less than approved by the FDA?
Yes. The approval of the application for GAMMAGARD LIQUID ERC [Immune Globulin Infusion (Human) with less than was announced on June 30, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. 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.