FDA issues Complete Response Letter for Disc Medicine's bitopertin NDA for EPP; approval delayed

Disc Medicine, Inc.

FDA acknowledged bitopertin significantly lowers PPIX but found insufficient evidence that PPIX change predicts clinical benefit.
Phase 3 APOLLO study ongoing; topline data expected Q4 2026; could support traditional approval.
Company plans Type A meeting with FDA; expects resubmission and decision by mid-2027 if APOLLO successful.
Disc Medicine has approximately $791M cash (unaudited, Dec 31, 2025) with runway into 2029.
CRL delays potential approval; stock likely to face negative pressure.

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