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.
CASI FDA Decision outcome unverified · 2025-12-07 Rebuilt daily · next FDA decision on the calendar · Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120) $2.47 $0.84 Historical price action; green = local high, red = low/sell-off.
Decision facts FDA decision date 2025-12-07
Outcome Unconfirmed · 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)
Validation Outcome consistent with price; primary-source verification in progress.
Market-cap tier Nano
Cohort decision-day move (history) 8.0% median (n=122)
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 → Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters .
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