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JSPR FDA Decision CRL · 2025-01-08

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

Mislabel: Phase 1b/2a BEACON clinical data, no NDA/CRL

Price into the decision (T-120)

Daily close, T-120 (7/24/24) through T+5. Run-up high $24.73 on 11/14/24, low $14.72 on 10/15/24 (T-120 to T-1). FDA decision 1/8/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-01-08

Outcome✗ CRL⚠ label corrected

Decision-day move-60.5%

T-120 run-up (low→high)+33.0% ($6.99→$24.73)

CRL reasonMislabel: Phase 1b/2a BEACON clinical data, no NDA/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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