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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GLSI FDA Decision outcome unverified · 2026-01-22

Rebuilt daily·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 1/22/26$29.29$7.858/7/25
Daily close, T-120 (8/7/25) through T+5. Run-up high $29.29 on 1/15/26, low $7.85 on 11/28/25 (T-120 to T-1). FDA decision 1/22/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-01-22
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move+5.7%
T-120 run-up (low→high)+148.0% ($7.85→$29.29)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierSmall
Cohort decision-day move (history)3.6% median (n=279)

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 →