CMC/Inspection CRL — Pre-license inspection deficiencies at the Reykjavik manufacturing facility (golimumab biosimilar AVT05); no other issues cited.
Historical price action; green = local high, red = low/sell-off.
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.