Daily close, T-120 (7/16/25) through T+5. Run-up high $2.97 on 8/28/25, low $0.851 on 9/3/25 (T-120 to T-1). FDA decision 12/31/25. Historical price action, not a forecast.
Positioning before the decision
On Dec 17, 2025, 14 days before the decision date, at-the-money options priced a move of ±91.8% through Jan 16, 2026 (the first listed expiry after the decision; ATM implied volatility 411%). The stock closed -15.3% at the first close across the decision and -68.4% 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 LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NORSE EIGHT) approved by the FDA?
Not in this review cycle. On December 31, 2025 the FDA issued a Complete Response Letter, declining to approve the application for LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NORSE EIGHT) in its current form. A CRL is not final; the primary source is linked on this page.
What was LYTENAVA (bevacizumab-vikg) / ONS-5010 - (NORSE EIGHT) under FDA review for?
The application covered Wet age-related macular degeneration (wet AMD). The FDA declined to approve the application in its current form on December 31, 2025.
How did OTLK stock react to the FDA decision?
On the decision day OTLK moved -15.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.