pdufa.bio
HomeFDA Decisions › ALDX 2025-04-03

ALDX FDA Decision CRL · 2025-04-03

efficacy CRL — Reproxalap dry-eye NDA CRL — efficacy not demonstrated

Price into the decision (T-120)

$6.92$1.89
Historical price action; green = local high, red = low/sell-off.

Decision facts

FDA decision date2025-04-03
Outcome✗ CRL✓ source-verified
Decision-day move-73.4%
T-120 run-up (low→high)+45.0% ($1.42→$6.98)
CRL reasonefficacy — Reproxalap dry-eye NDA CRL — efficacy not demonstrated
Primary sourceView filing ↗
Track upcoming FDA decisions live →
pdufa.bio · access required