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
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 source-verified approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on August 28, 2025. 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.