Disc Medicine Inc., Bitopertin · Erythropoietic Protoporphyria (EPP).
Run-up into the decision (T-120 → T+5)
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 2/13/26. 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?
Not in this review cycle. A Complete Response Letter, declining to approve the application for Bitopertin in its current form, was announced on February 13, 2026. A CRL is not final; the primary source is linked on this page.
Which company is behind Bitopertin?
Bitopertin is a Disc Medicine Inc. (IRON) program. The company announced the FDA decision on February 13, 2026; the FDA's own record of the decision is linked on this page.
How did IRON stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), IRON moved +18.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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