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LSTA FDA Decision CRL · 2025-01-22

Updated August 8, 2026·next FDA decision on the calendar

Mislabel: certepetide Phase 2b ASCEND data, no CRL

Price into the decision (T-120)

Daily close, T-120 (8/7/24) through T+5. Run-up high $3.9 on 1/21/25, low $2.52 on 12/25/24 (T-120 to T-1). FDA decision 1/22/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-01-22

Outcome✗ CRL⚠ label corrected

Decision-day move-29.5%

T-120 run-up (low→high)+23.0% ($2.43→$3.9)

CRL reasonMislabel: certepetide Phase 2b ASCEND data, no CRL

Primary sourceView filing ↗

Market-cap tierMicro

Cohort decision-day move (history)4.6% median (n=308)

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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