EQ FDA Decision CRL · 2025-03-27 Updated August 8, 2026 · next FDA decision on the calendar Mislabel: Phase 3 EQUATOR readout miss, no CRL
Price into the decision (T-120) PDUFA 3/27/25 $1.38 $0.6 10/10/24 Daily close, T-120 (10/10/24) through T+5. Run-up high $1.38 on 11/6/24, low $0.6 on 12/26/24 (T-120 to T-1). FDA decision 3/27/25. Historical price action, not a forecast.
Decision facts FDA decision date 2025-03-27
Outcome ✗ CRL ⚠ label corrected
Decision-day move -35.6%
T-120 run-up (low→high) +27.0% ($0.41→$0.94)
CRL reason Mislabel: Phase 3 EQUATOR readout miss, no CRL
Market-cap tier Nano
Cohort decision-day move (history) 8.0% median (n=116)
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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