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 (6/27/25) through T+5. Run-up high $9.93 on 6/27/25, low $6.42 on 10/15/25 (T-120 to T-1). FDA decision 12/12/25. Historical price action, not a forecast.
Positioning before the decision
On Nov 28, 2025, 14 days before the decision date, at-the-money options priced a move of ±16.7% through Dec 19, 2025 (the first listed expiry after the decision; ATM implied volatility 85%). The stock closed -0.1% at the first close across the decision and -3.8% 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 date2025-12-12
DrugORLADEYO (berotralstat)
IndicationPediatric patients with hereditary angioedema (HAE)
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 ORLADEYO (berotralstat) approved by the FDA?
Yes. The FDA approved the application for ORLADEYO (berotralstat) on December 11, 2025, per the FDA's own record. The company announced it on December 12, 2025. The primary source is linked on this page.
What was ORLADEYO (berotralstat) under FDA review for?
The application covered Pediatric patients with hereditary angioedema (HAE). The FDA approved the application on December 12, 2025.
How did BCRX stock react to the FDA decision?
On the decision day BCRX moved -0.1%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.