Unverified record. The outcome below was inferred from the share-price reaction around this date. Nobody has confirmed it against an FDA, SEC or company document, and it may be wrong: we have published at least one inferred outcome that turned out to be impossible (see corrections). Treat it as a price observation, not as a regulatory fact. Verified decisions on this site always link a primary source.
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VALN FDA Decision outcome unverified · 2025-08-25

Rebuilt daily·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 8/25/25$12.14$5.5023/10/25
Daily close, T-120 (3/10/25) through T+5. Run-up high $12.14 on 8/18/25, low $5.502 on 6/26/25 (T-120 to T-1). FDA decision 8/25/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-08-25
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move-19.0%
T-120 run-up (low→high)+74.0% ($5.5→$12.14)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierMicro
Cohort decision-day move (history)4.6% median (n=308)

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

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