pdufa.bio
HomeFDA Decisions › UNCY 2025-06-30

UNCY FDA Decision CRL · 2025-06-30

inspection CRL — OLC NDA CRL — third-party vendor cGMP inspection deficiency

Price into the decision (T-120)

$6.8$4.6
Historical price action; green = local high, red = low/sell-off.

Decision facts

FDA decision date2025-06-30
Outcome✗ CRL✓ source-verified
Decision-day move-29.9%
T-120 run-up (low→high)+57.0% ($4.6→$9.0)
CRL reasoninspection — OLC NDA CRL — third-party vendor cGMP inspection deficiency
Primary sourceView filing ↗
Track upcoming FDA decisions live →
pdufa.bio · access required