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Home › FDA Decisions › EQ 2025-03-27

EQ FDA Decision CRL · 2025-03-27

Updated ·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$0.610/10/24
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 date2025-03-27
Outcome✗ CRL⚠ label corrected
Decision-day move-35.6%
T-120 run-up (low→high)+27.0% ($0.41→$0.94)
CRL reasonMislabel: Phase 3 EQUATOR readout miss, no CRL
Primary sourceView filing ↗
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=117)

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

See the full 2026 PDUFA calendar →

Questions

Was source-verified approved by the FDA?

Not in this review cycle. On March 27, 2025 the FDA issued a Complete Response Letter, declining to approve the application for source-verified in its current form. A CRL is not final; the primary source is linked on this page.

How did EQ stock react to the FDA decision?

On the decision day EQ moved -35.6%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.