pdufa.bio
HomeFDA Decisions › ATRA 2025-01-16

ATRA FDA Decision CRL · 2025-01-16

inspection CRL — Ebvallo CRL — third-party manufacturer inspection findings

Price into the decision (T-120)

$16.85$6.57
Historical price action; green = local high, red = low/sell-off.

Decision facts

FDA decision date2025-01-16
Outcome✗ CRL✓ source-verified
Decision-day move-40.5%
T-120 run-up (low→high)+109.0% ($6.57→$18.0)
CRL reasoninspection — Ebvallo CRL — third-party manufacturer inspection findings
Primary sourceView filing ↗
Track upcoming FDA decisions live →
pdufa.bio · access required