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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AGIO FDA Decision outcome unverified · 2025-11-03

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Price into the decision (T-120)

PDUFA 11/3/25$43.45$28.035/19/25
Daily close, T-120 (5/19/25) through T+5. Run-up high $43.45 on 10/21/25, low $28.03 on 5/20/25 (T-120 to T-1). FDA decision 11/3/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-11-03
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move-7.2%
T-120 run-up (low→high)+23.0% ($35.0→$43.45)
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.

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