FBIO FDA Decision CRL · 2025-10-01

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)

Historical price action; green = local high, red = low/sell-off.

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.