Earnings summaries and quarterly performance for Disc Medicine.
Executive leadership at Disc Medicine.
Board of directors at Disc Medicine.
Research analysts covering Disc Medicine.
Recent press releases and 8-K filings for IRON.
Disc Medicine Provides Update on Lead Program Approval and Pipeline at JPMorgan Healthcare Conference
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine's lead program, bitopertin, for erythropoietic protoporphyria (EPP), is anticipated to receive potential FDA approval in late January or early February 2026, with the company prepared for launch into a $2 billion+ U.S. market opportunity.
- The company is advancing its pipeline with DISC-0974 for myelofibrosis anemia, in late-stage Phase II development and expected to move to Phase III in 2027, targeting a $4 billion+ market opportunity.
- DISC-3405, aimed at polycythemia vera and sickle cell disease, is in a Phase II trial with significant data expected by the end of 2026, with pivotal trials projected for early 2027.
- Disc Medicine maintains a strong financial position with $791 million in cash on hand as of year-end, providing a runway into 2029 that accounts for all planned activities, including Phase III trials and commercial team build-out, without assuming bitopertin revenue.
6 hours ago
Disc Medicine Anticipates FDA Approval and Launch of Bitopertin, Highlights Strong Financial Position and Pipeline Progress
IRON
Product Launch
Guidance Update
New Projects/Investments
7 hours ago
Disc Medicine Provides Update on Bitopertin Approval Timeline and Pipeline Progress
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine anticipates FDA approval for bitopertin for erythropoietic protoporphyria (EPP) by the end of January or early February 2026, following an accelerated review under the Commissioner's National Priority Voucher program.
- The company estimates a U.S. market of 14,000 diagnosed EPP patients, with 6,000 engaged patients, representing a potential $2 billion+ addressable market for bitopertin.
- Disc Medicine's pipeline includes DISC-0974 for anemias of inflammation (e.g., myelofibrosis, a $4 billion+ U.S. opportunity) and DISC-3405 for polycythemia vera (75,000 patients), with both programs targeting pivotal trials in 2027.
- The company reported $791 million in cash on hand as of year-end, providing a financial runway into 2029, which conservatively assumes no revenue from bitopertin.
8 hours ago
Disc provides corporate overview and pipeline updates at 44th Annual Healthcare Conference
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc's lead product, Bitopertin, for Erythropoietic Protoporphyria (EPP) has its New Drug Application (NDA) under FDA review via an accelerated approval pathway, with potential FDA approval and launch anticipated in early 2026.
- The company's pipeline includes DISC-0974 for Anemia of Myelofibrosis and Inflammatory Bowel Disease, and DISC-3405 for Polycythemia Vera and Sickle Cell Disease, with multiple data catalysts and study initiations expected through 2026-2027.
- Disc projects significant market opportunities for its key programs, with addressable markets estimated at $2 billion+ for EPP, $4 billion+ for MF Anemia, and $7 billion+ for PV.
- As of December 31, 2025, Disc reported a preliminary unaudited cash, cash equivalents, and marketable securities balance of $791 million, providing a financial runway into 2029.
8 hours ago
Disc Medicine, Inc. Outlines 2025 Achievements and 2026 Milestones
IRON
Product Launch
New Projects/Investments
Guidance Update
- Disc Medicine, Inc. reported unaudited cash, cash equivalents, and marketable securities of $791 million as of December 31, 2025, providing a financial runway into 2029.
- The company's bitopertin NDA was submitted and accepted under an accelerated approval pathway with priority review and was awarded the Commissioner’s National Priority Voucher (CNPV), with an FDA approval decision anticipated in early 2026 for the treatment of EPP.
- Positive initial Phase 2 data from the RALLY-MF study of DISC-0974 for anemia of myelofibrosis was presented in 2025, with updated data expected in H2 2026.
- Initial data from the Phase 2 study of DISC-3405 in polycythemia vera (PV) and Phase 1b study in sickle cell disease (SCD) is expected in H2 2026.
3 days ago
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
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