efficacy CRL: ONS-5010 wet-AMD BLA CRL: lacks substantial evidence
Price into the decision (T-120)
Daily close, T-120 (3/13/25) through T+5. Run-up high $2.97 on 8/25/25, low $1.14 on 4/11/25 (T-120 to T-1). FDA decision 8/28/25. Historical price action, not a forecast.
Positioning before the decision
On Aug 14, 2025, 14 days before the decision date, at-the-money options priced a move of ±39.5% through Sep 19, 2025 (the first listed expiry after the decision; ATM implied volatility 155%). The stock closed -54.1% at the first close across the decision and -62.6% 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 date2025-08-28
Outcome✗ CRL✓ source-verified
Decision-day move-54.2%
T-120 run-up (low→high)+101.0% ($0.85→$2.97)
CRL reasonefficacy: ONS-5010 wet-AMD BLA CRL: lacks substantial evidence
Not in this review cycle. On August 28, 2025 the FDA issued a Complete Response Letter, declining to approve the application for source-verified in its current form. A CRL is not final; the primary source is linked on this page.
How did OTLK stock react to the FDA decision?
On the decision day OTLK moved -54.2%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.