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Home › FDA Decisions › IRWD 2025-04-14

IRWD FDA Decision Approved · 2025-04-14

Updated ·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
DrugApraglutide - (STARS)
IndicationShort Bowel Syndrome with Intestinal Failure (SBS-IF)
Outcome✓ Approvedprimary-sourced
Decision-day move-31.5%
T-120 run-up (low→high)+25.0% ($0.65→$4.61)
ValidationVerified 2026-08-12: SEC filing 0001104659-25-034381 of 2025-04-14 containing 'approval of'
Market-cap tierMid
Cohort decision-day move (history)2.1% median (n=234)

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 →

Questions

Was Apraglutide - (STARS) approved by the FDA?

Yes. The FDA approved the application for Apraglutide - (STARS) on April 14, 2025. The primary source is linked on this page.

What was Apraglutide - (STARS) under FDA review for?

The application covered Short Bowel Syndrome with Intestinal Failure (SBS-IF). The FDA approved the application on April 14, 2025.

How did IRWD stock react to the FDA decision?

On the decision day IRWD moved -31.5%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.