other material
confidence high
sentiment positive
materiality 0.80
Disc Medicine aligns with FDA on bitopertin CRL path; APOLLO topline due Q4 2026
Disc Medicine, Inc.
- FDA Type A meeting aligned that successful Phase 3 APOLLO can serve as basis for CRL response; topline data expected Q4 2026.
- Cash, cash equivalents, and marketable securities of $717.7M as of June 30, 2026; net loss of $59.5M in Q2 2026 vs $55.2M in Q2 2025.
- RESTORE-PV Phase 2 of DISC-3405 fully enrolled; initial data now expected in Q3 2026.
- Selcodebart RALLY-MF data showed 56% major anemia response rate; end-of-Phase 2 FDA meeting expected by year-end.
- Expanded Access Program launched for bitopertin in EPP in the US and select geographies.