OTLK FDA Decision CRL · 2025-08-28
efficacy CRL — ONS-5010 wet-AMD BLA CRL — lacks substantial evidence
Price into the decision (T-120)
Historical price action; green = local high, red = low/sell-off.
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
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