Rebuilt daily·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
CMC/Manufacturing CRL, cGMP deficiencies at the CUTX-101 (Menkes disease) manufacturing facility; no efficacy or safety deficiencies cited.
Price into the decision (T-120)
Daily close, T-120 (4/16/25) through T+5. Run-up high $4 on 9/22/25, low $1.41 on 4/17/25 (T-120 to T-1). FDA decision 10/1/25. Historical price action, not a forecast.
Positioning before the decision
On Sep 17, 2025, 14 days before the decision date, at-the-money options priced a move of ±38.6% through Oct 17, 2025 (the first listed expiry after the decision; ATM implied volatility 210%). The stock closed -30.8% at the first close across the decision and -17.6% 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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was ZYCUBO approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for ZYCUBO in its current form, was announced on October 1, 2025. A CRL is not final; the primary source is linked on this page.
How did FBIO stock react to the FDA decision?
On the decision day FBIO moved -30.8%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.