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.
pdufa.bio
HomeFDA Decisions › IRWD 2025-04-14

IRWD FDA Decision outcome unverified · 2025-04-14

Rebuilt daily·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 4/14/25$5.04$0.9510/28/24
Daily close, T-120 (10/28/24) through T+5. Run-up high $5.04 on 11/14/24, low $0.95 on 4/11/25 (T-120 to T-1). FDA decision 4/14/25. Historical price action, not a forecast.

Decision facts

FDA decision date2025-04-14
OutcomeUnconfirmed · price consistent with approval~ price-only (validating)
Decision-day move-31.5%
T-120 run-up (low→high)+25.0% ($0.65→$4.61)
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierMid
Cohort decision-day move (history)2.2% median (n=229)

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 →