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IBRX FDA Decision CRL · 2026-01-16

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

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

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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