Page updated ·next FDA decision on the calendar·Data as of Oct 14, 2026 7:39 PM ET
Price into the decision (T-120)
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)
Every FDA approval letter and released Complete Response Letter we hold, by FDA action date: FDA approval letters.
Questions
Was Apraglutide approved by the FDA?
Yes. The approval of the application for Apraglutide was announced on April 14, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
What was Apraglutide 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.