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.
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 LYTENAVA (bevacizumab-vikg) / ONS-5010 approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for LYTENAVA (bevacizumab-vikg) / ONS-5010 in its current form, was announced on December 31, 2025. A CRL is not final; the primary source is linked on this page.
What was LYTENAVA (bevacizumab-vikg) / ONS-5010 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.