Daily close, T-120 (2/28/25) through T+5. Run-up high $1.95 on 7/14/25, low $1.17 on 4/14/25 (T-120 to T-1). FDA decision 8/15/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 1, 2025, 14 days before the decision date, at-the-money options priced a move of ±60.7% through Sep 19, 2025 (the first listed expiry after the decision; ATM implied volatility 224%). The stock closed +58.9% at the first close across the decision and +96.8% 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.
Was PAPZIMEOS (zopapogene imadenovec-drba) approved by the FDA?
Yes. The FDA approved the application for PAPZIMEOS (zopapogene imadenovec-drba) on August 15, 2025. The primary source is linked on this page.
What was PAPZIMEOS (zopapogene imadenovec-drba) under FDA review for?
The application covered Recurrent Respiratory Papillomatosis (RRP). The FDA approved the application on August 15, 2025.
How did PGEN stock react to the FDA decision?
On the decision day PGEN moved +58.9%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.