Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Mislabel: FDA discussions/ex-US approval, not a CRL
Price into the decision (T-120)
Daily close, T-120 (8/1/25) through T+5. Run-up high $3.95 on 1/15/26, low $1.98 on 12/31/25 (T-120 to T-1). FDA decision 1/16/26. Historical price action, not a forecast.
Decision facts
FDA decision date2026-01-16
Outcome✗ CRL⚠ label corrected
Decision-day move+39.7%
T-120 run-up (low→high)+101.0% ($1.98→$5.52)
CRL reasonMislabel: FDA discussions/ex-US approval, 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 January 16, 2026. A CRL is not final; the primary source is linked on this page.
How did IBRX stock react to the FDA decision?
On the decision day IBRX moved +39.7%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.