selcodebart (DISC-0974) / Disc Medicine, AbbVie - LARVOL DELTA

RALLY-MF: Initial efficacy of a phase 2 study of DISC-0974, an anti-hemojuvelin antibody, to treat anemia in myelofibrosis. (ASCO 2026) - P1/2 | "DISC-0974 was well tolerated and shows a favorable safety profile. Anemia response and fatigue scores improved across patients with MF and anemia, including those receiving JAKi therapy. These data validate hepcidin reduction as a promising approach to treating anemia in MF."

Clinical • P2 data • Anemia • Hematological Disorders • Myelofibrosis

Disc also presented an encore of the positive results from the Phase 2 RALLY-MF trial of selcodebart (DISC-0974) in patients with anemia of myelofibrosis (MF)…at the 2026 Society of Hematologic Oncology (SOHO) annual meeting (GlobeNewswire) - "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."

Clinical • FDA event • P2 data • Anemia • Myelofibrosis

A PHASE 1B/2 STUDY OF DISC-0974, AN ANTI-HEMOJUVELIN ANTIBODY, IN PATIENTS WITH MYELOFIBROSIS AND ANEMIA (EHA 2025) - P1/2 | "DISC-0974 demonstrated acceptable safety and tolerability at evaluated dose levels. Hematologic responses were achieved in all participants regardless of concomitant JAK-inhibitor use. Sustained hepcidin reduction with DISC-0974 increased serum iron that preceded hematological response."

Clinical • P1/2 data • Anemia • Dermatology • Fatigue • Hematological Disorders • Infectious Disease • Musculoskeletal Pain • Myelofibrosis • Pain

Disc Medicine Announces Multiple Presentations Across Portfolio at the Society of Hematologic Oncology (SOHO) 2026 Annual Meeting (GlobeNewswire) - "Abstract Title: RALLY-MF: Initial Efficacy of a Phase 2 Study of DISC-0974, an Anti-Hemojuvelin Antibody, to Treat Anemia in Myelofibrosis....These data, with a data cutoff date of April 27, 2026, will also be shared as part of the poster presentation as poster number MPN-120 on Wednesday, September 9th at 6:25 pm CT / 7:25 pm ET."

P2 data • Anemia • Myelodysplastic Syndrome • Myelofibrosis

RALLY-MF: Initial Efficacy of a Phase 2 Study of DISC-0974, an Anti-Hemojuvelin Antibody, to Treat Anemia in Myelofibrosis (SOHO 2026) - P1/2 | "Treatment with DISC-0974 demonstrated meaningful hematologic responses and favorable tolerability in MF-associated anemia independent of JAKi use, supporting hepcidin suppression as a therapeutic strategy for anemia in MF."

Clinical • P2 data • Myelofibrosis • Oncology

Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027 (The Manila Times)

P2 data • Trial status • Anemia • Inflammatory Bowel Disease

Recent Highlights and Anticipated Milestones: Selcodebart (DISC-0974) (Disc Medicine Press Release) - "Additional data from RALLY-MF anticipated in Q4 2026, with an end-of-Phase 2 meeting with the FDA expected to occur by year-end; Received EU Orphan Drug Designation for selcodebart for the treatment of myelofibrosis."

European regulatory • FDA event • Orphan drug • P2 data • Myelofibrosis

Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P1/2 | N=150 | Recruiting | Sponsor: Disc Medicine, Inc | Trial completion date: Sep 2026 ➔ Jun 2027 | Trial primary completion date: Sep 2026 ➔ May 2027

Trial completion date • Trial primary completion date • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera • Thrombocytosis

RALLY-MF: INITIAL EFFICACY OF A PHASE 2 STUDY OF DISC-0974, AN ANTI-HEMOJUVELIN ANTIBODY, TO TREAT ANEMIA IN MYELOFIBROSIS (EHA 2026) - P1/2 | "Forty - eight percent (26/54) received concomitant JAKi therapy , mostly momelotinib ( 5 4 % ) and ruxolitinib ( 38%) . Reused with permission. This abstract was accepted and previously presented at the 2026 ASCO Annual Meeting."

Clinical • P2 data • Anemia • Hematological Disorders • Myelofibrosis

DISC-0974: RALLY-MF Oral Presentation (GlobeNewswire) - "Disc Medicine presents positive clinical updates at the 2026 European Hematology Association (EHA) Annual Meeting....RALLY-MF, an ongoing Phase 2 open-label study, had enrolled 61 adult patients with MF and anemia as of the data cutoff date of April 27, including 50 patients with sufficient follow up to be included in the responder analysis....55% (N=17 of 31) of baseline nTD patients achieved a hemoglobin increase of ≥1.5 g/dL for ≥12 weeks (major response) and 68% had an increase of ≥1 g/dL for ≥12 weeks (overall response). 64% (N=7 of 11) of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period and 73% achieved a ≥50% reduction in transfusions (overall response). 50% (N=4 of 8) of TD High patients achieved transfusion independence (TI, major response) over a 12-week period and 88% achieved a ≥50% reduction in transfusion requirement (overall response)."

P2 data • Anemia • Myelofibrosis

Disc Medicine Presents Updated Positive Data from RALLY-MF Phase 2 Trial in Patients with Myelofibrosis (MF) and Anemia at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (Yahoo Finance) - "The updated results demonstrated: Consistent, substantial decreases in hepcidin reaching >75% reduction from baseline and corresponding increases in serum iron; 55% (N=17 of 31) of baseline nTD patients achieved a hemoglobin increase of ≥1.5 g/dL for ≥12 weeks (major response) and 68% had an increase of ≥1 g/dL for ≥12 weeks (overall response); 64% (N=7 of 11) of TD Low patients achieved transfusion independence (TI, major response) over a 16-week period and 73% achieved a ≥50% reduction in transfusions (overall response); 50% (N=4 of 8) of TD High patients achieved transfusion independence (TI, major response) over a 12-week period and 88% achieved a ≥50% reduction in transfusion requirement (overall response)....Additional data from the RALLY-MF study is to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year."

FDA event • P2 data • Anemia • Myelofibrosis

DISC-0974: Initiation of P3 trial for anemia of myelofibrosis in 2027 (Disc Medicine) - Corporate Presentation

New P3 trial • Hematological Malignancies • Myelofibrosis • Myeloproliferative Neoplasm • Oncology

Oral presentation of data from RALLY-MF phase 2 trial of DISC-0974 in patients with myelofibrosis and anemia (Disc Medicine Press Release) - "At the time of the abstract deadline, there were N=43 evaluable patients. Major response rates among evaluable patients at the abstract cutoff were 54% (15/28) for the non-transfusion dependent cohort, 67% (6/9) for the lightly transfused (TD Low) cohort, and 50% (3/6) for the heavily transfused (TD High) cohort. Overall response (major response + minor response) was 70%, with similar response regardless of concomitant JAK inhibitor therapy. Additional data and analyses will be included in the presentation at EHA."

P2 data • Myelofibrosis

DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) (GlobeNewswire) - "Updated data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be shared in an oral presentation at ASCO in June covering N=61 patients with data through April 27, 2026; Topline data from the RALLY-MF study to be shared in Q4 2026, with an end of Phase 2 meeting with the FDA expected to occur by end of year."

FDA event • P2 data • Anemia • Myelofibrosis

Progressing Phase 2 study in patients with inflammatory bowel disease (IBD) with initial data expected in 2027 (GlobeNewswire)

P2 data • Inflammatory Bowel Disease

DISC-0974-103: Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia (clinicaltrials.gov) - P1 | N=55 | Completed | Sponsor: Disc Medicine, Inc | Active, not recruiting ➔ Completed | Trial completion date: May 2026 ➔ Jan 2026

Trial completion • Trial completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Disc Medicine Announces Oral Presentation of Data from RALLY-MF Phase 2 Trial of DISC-0974 in Patients with Myelofibrosis and Anemia at the American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "'Initial data from the RALLY-MF trial showed anemia response rates that are unprecedented in the hard-to-treat myelofibrosis population.'...The abstract will be published online on the ASCO conference website on May 21, 2026. Pursuant to Disc Medicine practice, the abstract published will contain previously presented data, and new data and analyses are reserved for presentation at the conference."

P2 data • Anemia • Myelofibrosis

Study of DISC-0974-201 in Participants With IBD and Anemia (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: Disc Medicine, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease

Recent Highlights and Anticipated Milestones: DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) (GlobeNewswire) - "Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia initiated in Q1 2026 with initial data expected in 2027."

P2 data • Trial status • Anemia • Inflammatory Bowel Disease

Disc Medicine’s RALLY-IBD Trial Puts a Spotlight on Anemia Relief in IBD Patients (TipRanks) - "The trial tests DISC-0974, an injectable drug given under the skin. It is designed to improve anemia of inflammation in people with IBD, potentially reducing the need for transfusions or iron infusions and offering a more convenient option....Participants in the active arm receive 60 mg of DISC-0974 every 28 days for three doses, while the control arm gets placebo on the same schedule. The primary goal is treatment focused, looking at safety and early signs of benefit on anemia rather than long‑term outcomes."

Trial status • Anemia • Inflammatory Bowel Disease

ANTI-HEMOJUVELIN MONOCLONAL ANTIBODY REVERSES ANEMIA AND EXERTS DISEASE-MODIFYING EFFECTS IN A MOUSE MODEL OF INFLAMMATORY BOWEL DISEASE (CCCongress 2026) - P1, P1/2 | "Collectively, DBIO-100 reversed anemia and iron deficiency and exerted disease-modifying, anti-inflammatory effects in DSS-induced colitis. These results support DISC-0974 as a promising therapeutic for anemia in IBD, either as monotherapy or in combination with mesalamine."

Preclinical • Anemia • Chronic Kidney Disease • Colon Cancer • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Myelofibrosis • Nephrology • Renal Disease • IL6 • TNFA

Study of DISC-0974-201 in Participants With IBD and Anemia (clinicaltrials.gov) - P2 | N=21 | Not yet recruiting | Sponsor: Disc Medicine, Inc

New P2 trial • Anemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Bowel Disease

Key Business Objectives and Milestones for 2026:…DISC-0974: Anti-hemojuvelin Antibody (Hepcidin Suppression) (GlobeNewswire) - "(i) Progress ongoing Phase 2 MF anemia trial with updated data expected H2 2026; (ii) Conduct End of Phase 2 meeting with the FDA about DISC-0974 in MF anemia in H2 2026; (iii) Initiate a Phase 2 study of DISC-0974 in patients with anemia and inflammatory bowel disease (IBD)."

FDA event • New P2 trial • P2 data • Anemia • Inflammatory Bowel Disease • Myelofibrosis

Summary of Key Achievements During 2025 (GlobeNewswire) - "Issuance of a Composition of Matter patent for DISC-0974, providing patent exclusivity until 2041, not including potential extensions."

Patent • Anemia • Myelofibrosis

DISC-0974-103: Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Disc Medicine, Inc | Trial primary completion date: Sep 2025 ➔ Jan 2026

Trial primary completion date • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease