Daily close, T-120 (7/29/25) through T+5. Run-up high $4.38 on 1/8/26, low $1.81 on 8/7/25 (T-120 to T-1). FDA decision 1/13/26. Historical price action, not a forecast.
Positioning before the decision
On Dec 30, 2025, 14 days before the decision date, at-the-money options priced a move of ±36.5% through Jan 16, 2026 (the first listed expiry after the decision; ATM implied volatility 183%). The stock closed -7.1% at the first close across the decision and -17.1% 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.
Was ZYCUBO (copper histidinate) approved by the FDA?
Yes. The FDA approved the application for ZYCUBO (copper histidinate) on January 13, 2026. The primary source is linked on this page.
What was ZYCUBO (copper histidinate) under FDA review for?
The application covered Menkes disease. The FDA approved the application on January 13, 2026.
How did FBIO stock react to the FDA decision?
On the decision day FBIO moved -7.1%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.