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Home › FDA Decisions › IBRX 2026-01-16

IBRX FDA Decision CRL · 2026-01-16

Updated ·next FDA decision on the calendar
Mislabel: FDA discussions/ex-US approval, not a CRL

Price into the decision (T-120)

PDUFA 1/16/26$3.95$1.988/1/25
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
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 January 16, 2026 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 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.