DISC-0998 — Clinical data readout
H2 2026
Phase 2 data expected H2 2026Source filing
IRON biotech catalysts & pipeline
DISC MEDICINE INC · Data as of 2026-10-25
Upcoming catalysts
bitopertin — NDA/BLA submission
Late 2026
Based on these results, Disc plans to resubmit a New Drug Application (NDA) to the U.S. FDA by the end of 2026, with an FDA decision anticipated by mid-2027.Source filing
DISC-3405 — Initial data
Late 2026
Disc plans to provide an update on RESTORE-PV, as well as initial data from the Phase 1b trial of DISC-3405 in sickle cell disease, by the end of 2026.Source filing
selcodebart (DISC-0974) — FDA meeting
Late 2026
With respect to selcodebart, the company also expects to share feedback from an end of phase 2 meeting with the U.S. Food and Drug Administration (FDA) and plans for pivotal development in anemia of MF by the end of the year.Source filing
bitopertin — Topline data
early 2027
Continue enrollment of the global, confirmatory APOLLO study with topline data expected by early 2027Source filing
selcodebart (DISC-0974) — Initial data
2027
• Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027Source filing
bitopertin — PDUFA
mid-2027
Based on these results, Disc plans to resubmit a New Drug Application (NDA) to the U.S. FDA by the end of 2026, with an FDA decision anticipated by mid-2027.Source filing
bitopertin — Regulatory decision
mid-2027
On track to report APOLLO topline results in Q4 2026 and expect to submit CRL response and receive an FDA decision by mid-2027Source filing