other material
confidence high
sentiment negative
materiality 0.75
Disc Medicine discloses ITGC material weakness; outlines bitopertin NDA plan and 2025 milestones
Disc Medicine, Inc.
- Material weakness in ITGC over key financial IT systems; no misstatements identified to date.
- Bitopertin NDA submission plans to be discussed after Type C FDA meeting in Q1 2025; potential accelerated approval for EPP.
- Initial phase 2 data for DISC-0974 in myelofibrosis anemia expected H2 2025; multiple-dose CKD data also H2 2025.
- Phase 2 trial of DISC-3405 in polycythemia vera planned to start H1 2025.