CMC/Inspection CRL, Pre-license inspection deficiencies at the Reykjavik manufacturing facility (golimumab biosimilar AVT05); no other issues cited.
Price into the decision (T-120)
Daily close, T-120 (5/16/25) through T+5. Run-up high $11.45 on 6/6/25, low $7.82 on 9/18/25 (T-120 to T-1). FDA decision 11/2/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-11-02
Outcome✗ CRL✓ source-verified
Decision-day move-34.2%
T-120 run-up (low→high)+8.0% ($4.83→$9.81)
CRL reasonCMC/Inspection, Pre-license inspection deficiencies at the Reykjavik manufacturing facility (golimumab biosimilar AVT05); no other issues cited.
ValidationOutcome consistent with price; primary-source verification in progress.
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.