earnings
confidence high
sentiment neutral
materiality 0.75
Disc Medicine reports Q3 net loss of $62.3M; files NDA for bitopertin in EPP with priority review
Disc Medicine, Inc.
2025-Q3 EPS reported
-$4.39
- Submitted NDA for bitopertin in EPP seeking accelerated approval; FDA CNPV shortens review to 1-2 months; potential US launch late 2025/early 2026.
- Cash and equivalents $615.9M as of Sep 30; Oct public offering added ~$211M net; cash runway extended into 2029.
- R&D expenses $50.3M (up from $24.7M) driven by pipeline progression, including $10M milestone for DISC-3405.
- Net loss widened to $62.3M from $26.6M in Q3 2024 due to higher operating costs for clinical programs and commercial prep.
- Initial Phase 2 data for DISC-0974 in myelofibrosis anemia to be presented at ASH December 2025.