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Home › FDA Decisions › ESLA 2025-11-03

ESLA FDA Decision CRL · 2025-11-03

Updated ·next FDA decision on the calendar
Mislabel: STARLIGHT-1 Phase I cohort completion, no CRL

Price into the decision (T-120)

PDUFA 11/3/25$2.55$0.825/19/25
Daily close, T-120 (5/19/25) through T+5. Run-up high $2.55 on 10/30/25, low $0.82 on 7/18/25 (T-120 to T-1). FDA decision 11/3/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-11-03
Outcome✗ CRL⚠ label corrected
Decision-day move+26.0%
T-120 run-up (low→high)+247.0% ($0.82→$3.05)
CRL reasonMislabel: STARLIGHT-1 Phase I cohort completion, 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 November 3, 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 ESLA stock react to the FDA decision?

On the decision day ESLA moved +26.0%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.