Rebuilt daily·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Clinical/Endpoint CRL, Bitopertin (EPP): FDA wants the Phase 3 APOLLO result before deciding: the PPIX biomarker change isn't yet linked to sunlight-exposure benefit. Stock rose on relief / clear path.
Price into the decision (T-120)
Daily close, T-120 (8/29/25) through T+5. Run-up high $94.11 on 11/28/25, low $59.41 on 9/1/25 (T-120 to T-1). FDA decision 2/15/26. Historical price action, not a forecast.
CRL reasonClinical/Endpoint, Bitopertin (EPP): FDA wants the Phase 3 APOLLO result before deciding: the PPIX biomarker change isn't yet linked to sunlight-exposure benefit. Stock rose on relief / clear path.
ValidationOutcome consistent with price; primary-source verification in progress.
Market-cap tierSmall
Cohort decision-day move (history)3.7% median (n=302)
Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.
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?
Not in this review cycle. A Complete Response Letter, declining to approve the application for Bitopertin in its current form, was announced on February 15, 2026. A CRL is not final; the primary source is linked on this page.
How did IRON stock react to the FDA decision?
On the decision day IRON moved +17.2%. That is the recorded reaction to this specific event. Historical measurement, not a prediction, and not investment advice.