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 (2/10/25) through T+5. Run-up high $179.1 on 6/25/25, low $119.49 on 2/17/25 (T-120 to T-1). FDA decision 7/28/25. Historical price action, not a forecast.
Positioning before the decision
On Jul 14, 2025, 14 days before the decision date, at-the-money options priced a move of ±11.2% through Aug 15, 2025 (the first listed expiry after the decision; ATM implied volatility 47%). The stock closed -2.0% at the first close across the decision and +4.2% 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.
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 SKYTROFA (lonapegsomatropin-tcgd (ransCon hGH)) approved by the FDA?
Yes. The FDA approved the application for SKYTROFA (lonapegsomatropin-tcgd (ransCon hGH)) on July 25, 2025, per the FDA's own record. The company announced it on July 28, 2025. The primary source is linked on this page.
What was SKYTROFA (lonapegsomatropin-tcgd (ransCon hGH)) under FDA review for?
The application covered Growth Hormone Deficiency - adults. The FDA approved the application on July 28, 2025.
How did ASND stock react to the FDA decision?
On the decision day ASND moved -2.0%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.