other material
confidence high
sentiment positive
materiality 0.75
Disc Medicine reports $615.9M cash; bitopertin NDA submitted for accelerated review (CNPV)
Disc Medicine, Inc.
- Preliminary unaudited cash, equivalents and marketable securities of ~$615.9M as of September 30, 2025.
- NDA for bitopertin in EPP submitted Sept 29, 2025; awarded FDA CNPV for 1-2 month review; potential US approval late 2025/early 2026.
- Phase 2 RALLY-MF trial of DISC-0974 in anemia of MF: initial data by year-end 2025, topline data in 2026.
- DISC-3405 Phase 2 PV topline data expected 2026; Phase 1b in sickle cell disease by year-end 2025.