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JSPR FDA Decision CRL · 2025-07-07

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

Mislabel: clinical data update/restructuring, not a CRL

Price into the decision (T-120)

Daily close, T-120 (1/20/25) through T+5. Run-up high $7.05 on 1/20/25, low $3.47 on 4/14/25 (T-120 to T-1). FDA decision 7/7/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-07-07

Outcome✗ CRL⚠ label corrected

Decision-day move-55.1%

T-120 run-up (low→high)+20.0% ($3.02→$6.82)

CRL reasonMislabel: clinical data update/restructuring, not a 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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