Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Mislabel: IND-stage; clinical hold not CRL, no NDA
Price into the decision (T-120)
Daily close, T-120 (12/17/24) through T+5. Run-up high $13.42 on 1/6/25, low $1.1 on 5/16/25 (T-120 to T-1). FDA decision 6/3/25. Historical price action, not a forecast.
Decision facts
FDA decision date2025-06-03
Outcome✗ CRL⚠ label corrected
Decision-day move+31.7%
T-120 run-up (low→high)+14.0% ($1.1→$8.29)
CRL reasonMislabel: IND-stage; clinical hold not CRL, no NDA
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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 June 3, 2025. A CRL is not final; the primary source is linked on this page.
How did TRAW stock react to the FDA decision?
On the decision day TRAW moved +31.7%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.