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Disc Medicine, Inc. Provides Update on Pipeline Progress and Bitopertin NDA Review
IRON
Product Launch
New Projects/Investments
Guidance Update
- The New Drug Application (NDA) for bitopertin has been accepted and is part of the FDA's Commissioner's National Priority Voucher (CNPV) Pilot Program, with an anticipated action date and potential launch by the end of January 2026.
- Interim Phase 2 data for DISC-0974 in anemia of myelofibrosis (MF) showed positive, durable benefits on hemoglobin and transfusion burden, with an overall response rate of 63-71% and a major response rate of 50-71% in nTD and TD Low cohorts.
- The company has initiated a Phase 2 study for DISC-3405 in polycythemia vera and a Phase 1b study in sickle cell disease, with initial data from both studies expected by the end of 2026.
- Disc Medicine, Inc. is funded into 2029, supporting potential bitopertin commercialization and several key pipeline milestones.
Dec 8, 2025, 1:40 PM
Disc Medicine Updates on Bitopertin NDA, RALLI-MF Data, and Pipeline Progress
IRON
Product Launch
New Projects/Investments
Guidance Update
- The New Drug Application (NDA) for bitopertin in erythropoietic protoporphyria (EPP) has been accepted for review, with an anticipated approval decision and potential launch by the end of January 2026 under the Commissioner's National Priority Voucher Program.
- Interim data from the Phase 2 RALLI-MF study of DISC-0974 in patients with anemia of myelofibrosis showed consistent and substantial decreases in hepcidin, leading to iron mobilization and durable benefits on hemoglobin, transfusion burden, and fatigue, regardless of underlying MF-directed therapy.
- Disc Medicine has initiated a Phase 2 polycythemia vera trial (Restore PV) and a Phase 1b sickle cell disease trial for DISC-3405, with initial data expected in 2026 for both indications.
- The company is funded into 2029 following two follow-on offerings, a runway that does not include any revenue projections from bitopertin.
Dec 7, 2025, 12:30 PM
Disc Medicine Provides Updates on Bitopertin NDA, DISC-0974 RALLI-MF Data, and Pipeline Progress
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine announced the NDA for bitopertin has been accepted for review and is designated for priority review under the accelerated approval pathway, with a potential approval decision and launch by the end of January 2026.
- Initial data from the Phase 2 RALLI-MF study of DISC-0974 in anemia of myelofibrosis showed consistent and substantial decreases in hepcidin, leading to durable benefits in hemoglobin, transfusion burden, and fatigue. The drug demonstrated strong overall response rates (63% in non-transfusion-dependent and 71% in transfusion-dependent low cohorts) regardless of concomitant JAK inhibitor therapy.
- The company has initiated two inpatient studies for DISC-3405 in polycythemia vera and sickle cell disease, with initial data expected in 2026.
- Disc Medicine is funded into 2029, a runway that does not include any revenue projections from bitopertin.
Dec 7, 2025, 12:30 PM
DISC Medicine Announces Bitopertin NDA Acceptance and Positive DISC-0974 Rally MF Data
IRON
Product Launch
New Projects/Investments
- DISC Medicine's Bitopertin New Drug Application (NDA) has been accepted for review by the FDA under the Commissioner's National Priority Voucher Program, with an anticipated approval decision and potential launch by the end of January 2026.
- Initial data from the Phase 2 Rally MF study of DISC-0974 in anemia of myelofibrosis showed consistent and substantial decreases in hepcidin, leading to durable benefits in hemoglobin, transfusion burden, and fatigue.
- DISC-0974 demonstrated strong efficacy regardless of concomitant JAK inhibitor therapy, with overall response rates of 63% in non-transfusion dependent and 71% in low-transfusion dependent patients, and is considered to have the potential to reach blockbuster status in anemia of myelofibrosis.
- The company plans to present further Phase 2 data for DISC-0974 in H2 2026 and initiate a pivotal trial in H1 2027.
Dec 7, 2025, 12:30 PM
Disc Provides Updates on Bitopertin, DISC-0974, and DISC-3405 Programs
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc's Bitopertin New Drug Application (NDA) was accepted on November 28, with a potential launch and anticipated action date by the end of January 2026 due to its selection for the FDA's Commissioner's National Priority Voucher (CNPV) Pilot Program.
- Interim Phase 2 results for DISC-0974 in Anemia of Myelofibrosis (MF) demonstrated consistent decreases in hepcidin and increases in serum iron, leading to positive, durable benefits on hemoglobin and transfusion burden, with topline data expected in H2 2026.
- Disc plans to initiate a Phase 2 study for DISC-0974 in Anemia of Inflammatory Bowel Disease (IBD) in Q1 2026.
- DISC-3405 is progressing with an ongoing Phase 2 study in polycythemia vera and a Phase 1b study initiated in sickle cell disease, with initial data from both studies anticipated by the end of 2026.
Dec 7, 2025, 12:30 PM
DISC Medicine Provides Update on Drug Pipeline and Regulatory Progress
IRON
Product Launch
New Projects/Investments
- DISC Medicine announced the NDA for Bitopertin has been officially accepted for review by the FDA, with an anticipated approval decision and potential launch by the end of January 2026. The submission was designated as priority review under the accelerated approval pathway.
- Initial data from the Phase 2 Rally MF study of DISC-0974 in anemia of myelofibrosis showed consistent and substantial decreases in hepcidin, leading to durable benefits on hemoglobin, transfusion burden, and fatigue, with overall response rates of over 60%. A pivotal trial is anticipated in the first half of 2027.
- The company has initiated two proof-of-concept studies for DISC-3405 in Polycythemia Vera and Sickle Cell Disease, with initial data expected in 2026.
- DISC Medicine is funded into 2029, a runway that does not include any revenue projections from Bitopertin.
Dec 7, 2025, 12:30 PM
Disc Medicine Provides Update on Accelerated Bitopertin Approval and Pipeline Progress
IRON
Product Launch
New Projects/Investments
Guidance Update
Nov 19, 2025, 2:00 PM
Disc Medicine Provides Updates on Bitopertin, DISC-0974, and Financial Position
IRON
Product Launch
Guidance Update
New Projects/Investments
- Disc Medicine submitted an NDA for bitopertin for erythropoietic protoporphyria (EPP) at the end of September, with potential approval and launch by late 2025 or early 2026 due to an accelerated approval process and a national priority voucher.
- The company expects to present 40-50 patients' worth of data from its Phase 2 RALI-MF trial for DISC-0974 in anemia in myelofibrosis at ASH 2025, following positive data from 35 patients presented at ASH 2024.
- Disc Medicine has initiated a Phase 2 trial for its polycythemia vera program, with data expected in 2026 and a potential move to a pivotal trial within 12-18 months.
- The company's balance sheet holds approximately $825 million, providing a cash runway until 2029 without accounting for potential revenue.
Nov 19, 2025, 2:00 PM
Disc Medicine's Bidapertin Nears Accelerated Approval, Pipeline Advances, and Strong Financial Position Reported
IRON
Product Launch
Guidance Update
New Projects/Investments
- Disc Medicine submitted the NDA for its lead program, Bidapertin, for erythropoietic protoporphyria (EPP) at the end of September and received an FDA Commissioner's National Priority Voucher, accelerating the review time to one to two months after acceptance, with potential approval in December or January.
- Phase 2 data for Disc 974 in anemia of myelofibrosis will be presented at ASH this year, following extraordinary efficacy in the Phase 1B study. The first data readout for Disc 3405 in polycythemia vera is expected next year, with exploration also underway in sickle cell disease.
- The company recently completed a financing, resulting in a pro forma balance of approximately $820 million, providing a cash runway into 2029, which does not include potential Bidapertin revenues or PRV voucher sales.
Nov 13, 2025, 1:40 PM
Disc Medicine Updates on Bidapertin Approval Timeline, Pipeline Progress, and Financial Outlook
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine's lead program, Bidapertin, for erythropoietic protoporphyria (EPP), is on an accelerated FDA review pathway following its September NDA submission and receipt of a National Priority Voucher, with potential approval by December or January.
- The company anticipates presenting new Phase 2 data for Disc 974 in anemia of myelofibrosis at ASH this year and expects initial Phase 2 data for Disc 3405 in polycythemia vera and sickle cell disease next year.
- Following a recent financing, Disc Medicine holds approximately $820 million on its balance sheet, providing a cash runway into 2029, which does not account for potential Bidapertin revenues or PRV sales.
Nov 13, 2025, 1:40 PM
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