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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REGN FDA Decision outcome unverified · 2026-02-24

Rebuilt daily·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 2/24/26$812.27$555.519/9/25
Daily close, T-120 (9/9/25) through T+5. Run-up high $812.27 on 1/9/26, low $555.51 on 10/2/25 (T-120 to T-1). FDA decision 2/24/26. Historical price action, not a forecast.

Decision facts

FDA decision date2026-02-24
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move-1.9%
T-120 run-up (low→high)+41.0% ($575.69→$812.27)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierLarge
Cohort decision-day move (history)1.0% median (n=827)

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 →