Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Price into the decision (T-120)
Daily close, T-120 (8/6/24) through T+5. Run-up high $67.47 on 12/16/24, low $41.27 on 8/15/24 (T-120 to T-1). FDA decision 1/21/25. Historical price action, not a forecast.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was Bitopertin approved by the FDA?
Yes. The approval of the application for Bitopertin was announced on January 21, 2025; pdufa.bio holds no FDA record stating the exact day the FDA acted. The primary source is linked on this page.
What was Bitopertin under FDA review for?
The application covered Erythropoietic Protoporphyria (EPP). The FDA approved the application on January 21, 2025.
How did IRON stock react to the FDA decision?
On the decision day IRON moved +3.9%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.