CMC/Manufacturing CRL, cGMP deficiencies at the CUTX-101 (Menkes disease) manufacturing facility; no efficacy or safety deficiencies cited.
Price into the decision (T-120)
Daily close, T-120 (4/16/25) through T+5. Run-up high $4 on 9/22/25, low $1.41 on 4/17/25 (T-120 to T-1). FDA decision 10/1/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-10-01
Outcome✗ CRL✓ source-verified
Decision-day move-30.8%
T-120 run-up (low→high)+112.0% ($1.71→$4.0)
CRL reasonCMC/Manufacturing, cGMP deficiencies at the CUTX-101 (Menkes disease) manufacturing facility; no efficacy or safety deficiencies cited.
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=279)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.