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Home › FDA Decisions › OTLK 2025-08-28

OTLK FDA Decision CRL · 2025-08-28

Updated ·next FDA decision on the calendar
efficacy CRL: ONS-5010 wet-AMD BLA CRL: lacks substantial evidence

Price into the decision (T-120)

PDUFA 8/28/25$2.97$1.143/13/25
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.

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
Primary sourceView filing ↗
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=116)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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