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IRON FDA decision — Feb 13, 2026

✕ COMPLETE RESPONSE LETTER

Disc Medicine Inc. — Bitopertin - (BEACON) · Erythropoietic Protoporphyria (EPP).

Run-up into the decision (T-120 → T+5)

PDUFA 2/13/26$94.11$59.418/29/25
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.

Key facts

FDA decision date2026-02-13
OutcomeCRL
Drug / candidateBitopertin - (BEACON)
CompanyDisc Medicine Inc.
120-day run-up (T-120→T-1)+18.7%