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 (6/19/25) through T+5. Run-up high $28.65 on 11/28/25, low $9.29 on 6/24/25 (T-120 to T-1). FDA decision 12/4/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 20, 2025, 14 days before the decision date, at-the-money options priced a move of ±24.5% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 111%). The stock closed +16.0% at the first close across the decision and +5.9% 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.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was Avance Nerve Graf approved by the FDA?
Yes. The approval of the application for Avance Nerve Graf was announced on December 4, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
What was Avance Nerve Graf under FDA review for?
The application covered Severed peripheral nerves. The FDA approved the application on December 4, 2025.
How did AXGN stock react to the FDA decision?
On the decision day AXGN moved +16.0%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.