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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CASI FDA Decision outcome unverified · 2025-12-07

Rebuilt daily·next FDA decision on the calendar

Price into the decision (T-120)

$2.47$0.84
Historical price action; green = local high, red = low/sell-off.

Decision facts

FDA decision date2025-12-07
OutcomeUnconfirmed · price consistent with a CRL~ price-only (validating)
Decision-day move-3.1%
T-120 run-up (low→high)+27.0% ($0.84→$2.47)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierNano
Cohort decision-day move (history)8.0% median (n=116)

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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