COMPANY

Disc Medicine

HQ: Watertown, MA source · discmedicine.com ↗ · New England

Keywords: hematology rare disease Erythropoietic Protoporphyria X-Linked Protoporphyria Anemia Sickle Cell Disease Inflammatory Bowel Disease Myelofibrosis Primary Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Myelodysplastic Syndromes Polycythemia Vera Chronic Kidney Diseases Anemia of Chronic Kidney Disease DISC-1459 DISC-3405 DISC-0974

Location: Watertown, MA · source · Oct 15, 2026

Profile checked Oct 10, 2026

$450.5MRaised (2 yrs)11Trials (company is sponsor)

Trial and FDA signals

FDA complete response letter Received an FDA complete response letter (NDA 220707, letter dated Feb 13, 2026). FDA NDA 220707 (Feb 13, 2026)
Evidence (1 event)
- Feb 13, 2026 · FDA NDA 220707
  CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Disc Medicine, Inc. Attention: Steve Caffé, MD Chief Regulatory Officer Watertown, MA (street omitted) Dear Dr. Caffé: Please refer to your new drug application (N

Job counts as of Oct 18, 2026. All trial and FDA signals

Timeline

Feb 20, 2026 Trial start Phase 2: Study of DISC-0974-201 in Participants With IBD and Anemia source ↗
Jan 6, 2026 Trial start 1: A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD) source ↗
Oct 21, 2025 Raise Follow-on offering: $225M (total, as published), announced Oct 21, 2025. Source: SEC filing. source ↗
Aug 12, 2025 Trial start 2: A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV) source ↗
Apr 4, 2025 Trial start Phase 3: Study of Bitopertin in Participants With EPP or XLP (APOLLO) source ↗
Jan 22, 2025 Raise Follow-on offering: $225.5M (total, as published), announced Jan 22, 2025. Source: SEC filing. source ↗
Nov 8, 2024 Debt Debt: $200M (not counted as a raise), announced Nov 8, 2024. Source: SEC filing. source ↗
Oct 3, 2023 Trial start Phase 1: A Study of DISC-3405 in Healthy Volunteers source ↗
Aug 31, 2023 Trial start Phase 2/Phase 3: HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP source ↗
Apr 4, 2023 Trial start Phase 1: Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia source ↗
Oct 31, 2022 Trial start Phase 2: Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP source ↗
Jun 6, 2022 Trial start Phase 1/Phase 2: Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia source ↗
Aug 10, 2021 Trial start Phase 1: Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects source ↗

Upcoming milestones

2026-10 (ESTIMATED) · Phase 2 · Study of DISC-0974-201 in Participants With IBD and Anemia · NCT07368972
2027-02 (ESTIMATED) · 2 · A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV) · NCT06985147
2027-05 (ESTIMATED) · Phase 1/Phase 2 · Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia · NCT05320198
2027-06 (ESTIMATED) · 1 · A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD) · NCT07187973
2028-06 (ESTIMATED) · Phase 2/Phase 3 · HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP · NCT05883748

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $450.5M · Debt: $200.0M. Last 2 years.

Oct 21, 2025 Follow-on offering: $225M (total, as published), announced Oct 21, 2025. Source: SEC filing. source ↗
Jan 22, 2025 Follow-on offering: $225.5M (total, as published), announced Jan 22, 2025. Source: SEC filing. source ↗
Nov 8, 2024 Debt: $200M (not counted as a raise), announced Nov 8, 2024. Source: SEC filing. source ↗

Clinical trials (lead sponsor) 11

Record	Title	Phase	Status	Start	Primary completion
NCT05883748	HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP	Phase 2/Phase 3	Enrolling by invitation	Aug 31, 2023	2028-06 (estimated)
NCT06910358	Study of Bitopertin in Participants With EPP or XLP (APOLLO)	Phase 3	Completed	Apr 4, 2025	Sep 8, 2026 (actual)
NCT07603401	Expanded Access Program of Bitopertin For Participants With EPP or XLP	Not listed	Available	Not listed	Not listed
NCT07187973	A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD)	1	Recruiting	Jan 6, 2026	2027-06 (estimated)
NCT07368972	Study of DISC-0974-201 in Participants With IBD and Anemia	Phase 2	Recruiting	Feb 20, 2026	2026-10 (estimated)
NCT05320198	Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia	Phase 1/Phase 2	Recruiting	Jun 6, 2022	2027-05 (estimated)
NCT06985147	A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)	2	Active, not recruiting	Aug 12, 2025	2027-02 (estimated)
NCT05745883	Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia	Phase 1	Completed	Apr 4, 2023	Oct 9, 2025 (actual)
NCT05308472	Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP	Phase 2	Completed	Oct 31, 2022	Feb 20, 2024 (actual)
NCT06050915	A Study of DISC-3405 in Healthy Volunteers	Phase 1	Completed	Oct 3, 2023	Jul 9, 2024 (actual)
NCT04999527	Study to Evaluate the Safety, Tolerability, PK and PD of DISC-0974 in Healthy Subjects	Phase 1	Completed	Aug 10, 2021	Jun 30, 2022 (actual)

Raises and investors new

Form D raises come from the company’s own SEC filing (last 2 years).

InvestorListed in the portfolio of Atlas Venture (captured Oct 12, 2026). portfolio page ↗
InvestorListed in the portfolio of OrbiMed (captured Oct 12, 2026). portfolio page ↗
InvestorListed in the portfolio of Bain Capital Life Sciences (captured Oct 12, 2026). portfolio page ↗