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 (1/20/25) through T+5. Run-up high $14.76 on 6/11/25, low $7.4 on 1/22/25 (T-120 to T-1). FDA decision 7/7/25. Historical price action, not a forecast.
Positioning before the decision
On Jun 23, 2025, 14 days before the decision date, at-the-money options priced a move of ±24.7% through Jul 18, 2025 (the first listed expiry after the decision; ATM implied volatility 113%). The stock closed +25.7% at the first close across the decision and +21.2% 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.
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was EKTERLY (sebetralstat) approved by the FDA?
Yes. The FDA approved the application for EKTERLY (sebetralstat) on July 3, 2025, per the FDA's own record. The company announced it on July 7, 2025. The primary source is linked on this page.
What was EKTERLY (sebetralstat) under FDA review for?
The application covered Hereditary Angioedema (HAE). The FDA approved the application on July 7, 2025.
How did KALV stock react to the FDA decision?
On the decision day KALV moved +25.7%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.