Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
Daily close, T-120 (5/2/25) through T+5. Run-up high $309.22 on 7/24/25, low $262.28 on 5/20/25 (T-120 to T-1). FDA decision 10/17/25. Historical price action, not a forecast.
Positioning before the decision
On Oct 3, 2025, 14 days before the decision date, at-the-money options priced a move of ±4.7% through Oct 24, 2025 (the first listed expiry after the decision; ATM implied volatility 24%). The stock closed +1.0% at the first close across the decision and -1.0% 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 date2025-10-17
DrugTEZSPIRE (tezepelumab-ekko)
IndicationChronic Rhinosinusitis with Nasal Polyps (CRwNP)
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was TEZSPIRE (tezepelumab-ekko) approved by the FDA?
Yes. The FDA approved the application for TEZSPIRE (tezepelumab-ekko) on October 17, 2025, per the FDA's own record. The primary source is linked on this page.
What was TEZSPIRE (tezepelumab-ekko) under FDA review for?
The application covered Chronic Rhinosinusitis with Nasal Polyps (CRwNP). The FDA approved the application on October 17, 2025.
How did AMGN stock react to the FDA decision?
On the decision day AMGN moved +1.0%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.