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Home › FDA Decisions › JSPR 2025-07-07

JSPR FDA Decision CRL · 2025-07-07

Updated ·next FDA decision on the calendar
Mislabel: clinical data update/restructuring, not a CRL

Price into the decision (T-120)

PDUFA 7/7/25$7.05$3.471/20/25
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.

See the full 2026 PDUFA calendar →

Questions

Was source-verified approved by the FDA?

Not in this review cycle. On July 7, 2025 the FDA issued a Complete Response Letter, declining to approve the application for source-verified in its current form. A CRL is not final; the primary source is linked on this page.

How did JSPR stock react to the FDA decision?

On the decision day JSPR moved -55.1%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.