Disc Medicine announces feedback from pre-NDA meeting with FDA for bitopertin

Disc Medicine (IRON) announced positive feedback from its pre-New Drug Application, NDA, meeting with the U.S. Food and Drug Administration, FDA, to discuss the planned NDA submission for bitopertin in EPP. The purpose of the meeting was to confirm the FDA’s expectations for the proposed timing, format and content of the planned NDA submission. Based on feedback from the FDA, Disc plans to submit an NDA for bitopertin in EPP in October 2025 under the FDA’s accelerated approval pathway based on Disc’s existing data package.