Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
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
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was source-verified approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on July 7, 2025. 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.