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ALDX FDA Decision CRL · 2025-04-03

Updated ·next FDA decision on the calendar
efficacy CRL: Reproxalap dry-eye NDA CRL: efficacy not demonstrated

Price into the decision (T-120)

PDUFA 4/3/25$6.98$4.2110/17/24
Daily close, T-120 (10/17/24) through T+5. Run-up high $6.98 on 3/12/25, low $4.21 on 11/25/24 (T-120 to T-1). FDA decision 4/3/25. Historical price action, not a forecast.

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 ↗
Market-cap tierMid
Cohort decision-day move (history)2.2% median (n=229)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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