Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Mislabel: STARLIGHT-1 Phase I cohort completion, no CRL
Price into the decision (T-120)
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
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was source-verified approved by the FDA?
Not in this review cycle. A Complete Response Letter, declining to approve the application for source-verified in its current form, was announced on November 3, 2025. 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.