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Home › FDA Decisions › TRAW 2025-06-03

TRAW FDA Decision CRL · 2025-06-03

Updated ·next FDA decision on the calendar
Mislabel: IND-stage; clinical hold not CRL, no NDA

Price into the decision (T-120)

PDUFA 6/3/25$13.42$1.112/17/24
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
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 June 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 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.