elritercept (TAK-226) / Keros Therap, Jiangsu Hansoh Pharma, Takeda - LARVOL DELTA

ELRITERCEPT (KER-050) DEMONSTRATED POTENTIAL TO TREAT MYELOFIBROSIS AND MITIGATE RUXOLITINIB-ASSOCIATED CYTOPENIAS IN THE PHASE 2 RESTORE TRIAL (EHA 2024) - P2 | "These data from RESTORE suggest that elritercept was generally well tolerated and has potential to treatseveral aspects of MF. Improvements in Hgb and transfusion burden with maintenance of plateletsdemonstrate potential to address ineffective hematopoiesis and treat cytopenias associated with MF andruxolitinib. Data also support potential for elritercept to reduce spleen size and improve symptoms."

P2 data • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Myelofibrosis • Oncology • Thrombocytopenia • ACVR2A • TGFB1

Hematological and clinical improvements with elritercept (KER-050, TAK-226) at the recommended Phase 2 dose (RP2D) in patients with myelofibrosis (MF) receiving ruxolitinib: Updated results from the Phase 2 restore trial (ASH 2025) - P2 | "For the remainder of pts with available data, the VAFremained unchanged at wks 24 and 52 with further follow-up ongoing.ConclusionsElritercept as an add on treatment at the RP2D demonstrated clinically meaningful improvements inanemia, thrombocytopenia, spleen volume and symptoms in MF pts receiving ruxolitinib. Emerging datasuggest potential effects on clonal architecture and hematopoietic restoration, even in advanced disease.These findings support elritercept as a differentiated therapy in the treatment of pts with MF."

Clinical • P2 data • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Thrombocytopenia • ACVR2A • INHBB • JAK2 • TGFB1

A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept vs Placebo in Patients With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy: The ELRISE MF Study Design (SOHO 2026) - "Other secondary endpoints include spleen volume reduction, platelet response, and changes from baseline in PROMIS Short Form v1.0-Fatigue 7a T-score and MFSAF v4.0 7-item Total Symptom Score at week 36. ECOG: Eastern Cooperative Oncology Group, GDF: growth differentiation factors, JAK: Janus kinase, IgG1: immunoglobulin G1, MF: myelofibrosis, MFSAF: MF Symptom Assessment Form, NCT: national clinical trial, PROMIS: patient-reported outcomes measurement information system, PS: performance status scale, RBC: red blood cell, TGF-β: transforming growth factor-β, TD: transfusion-dependence, TI: transfusion-independence."

Clinical • P3 data • Myelofibrosis • Oncology • TGFB1

UPDATE FROM THE PHASE 2 RESTORE TRIAL OF ELRITERCEPT IN PATIENTS WITH MYELOFIBROSIS (MF) RECEIVING RUXOLITINIB (EHA 2026) - P2 | "©American Society of Hematology (2025). Reused with permission"

Clinical • P2 data • Hematological Disorders • Myelofibrosis • Thrombocytopenia • ACVR2A • JAK2

Update From the, Phase 2 RESTORE Trial of Elritercept in Patients With Myelofibrosis Receiving Ruxolitinib (SOHO 2026) - P2 | "Elritercept with ruxolitinib showed improvements in transfusion burden, spleen volume, platelet counts, and symptoms in patients with myelofibrosis, supporting further evaluation. GDF8/11: growth/differentiation factor 8/11, JAK: Janus kinase, JAK2: Janus kinase 2, MF-SAF-TSS: Myelofibrosis Symptom Assessment Form Total Symptom Score, RBC: red blood cell, TGF-β: tumor growth factor beta, VAF: variant allele frequency. Reused with permission."

Clinical • P2 data • Myelofibrosis • Oncology • ACVR2A • JAK2 • TGFB1

Closing the disease modification gap: Emerging therapies in myelofibrosis beyond JAK inhibition. (PubMed, Semin Hematol) - "We discuss BET inhibitors (pelabresib), PIM kinase inhibitors (TP-3654), telomerase inhibition (imetelstat), nuclear export inhibition (selinexor), LSD1 inhibition (bomedemstat), MDM2 antagonism (navtemadlin), mutant CALR-directed immunotherapies, and activin receptor ligand traps (elritercept). Strategies such as high-molecular-risk mutation profiling and variant allele frequency monitoring to assess disease progression and clonal burden will also be discussed. As the focus of MPN management shifts towards curative nontransplant options, a combination of improved access to clinical trials and accounting for patient-reported outcomes will be vital if we are to realize the promise of these next-generation therapies."

IO biomarker • Journal • Fibrosis • Hematological Disorders • Immunology • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Transplantation • CALR

The first patient globally has been enrolled in the phase 3 TAK-226-3001 trial (NCT07422480) evaluating elritercept (TAK-226) vs epoetin alfa-epbx (Epogen) for the treatment of anemia in adults with lower-risk myelodysplastic syndromes (MDS), according to a news release from King’s College Hospital NHS Foundation Trust. (Cancer Network) - "King’s College Hospital in London enrolled the first patient and is one of 2 UK sites taking part in the global study, which plans to enroll a population of 300 patients who may remain in the trial for up to 5 years."

Enrollment open • Myelodysplastic Syndrome

Durable Clinical Benefit with Ker-050 Treatment: Findings from an Ongoing Phase 2 Study in Participants with Lower-Risk MDS (ASH 2023) - P2 | "At baseline, most participants receiving KER-050 at the RP2D (74.6%) required regular transfusions (≥2 RBC units/8 weeks); 52.5% of RP2D participants had HTB (≥4 RBC units/8 weeks) and 20.3% had ≥8 RBC units/8 weeks (Table 1). The median treatment duration was 166 days (range 6 to 649). Most participants (89.8%) had at least 1 treatment-emergent adverse event (TEAE), and 32.2% had TEAEs considered treatment-related (Table 1)."

Clinical • P2 data • Fatigue • Hematological Disorders • Hematological Malignancies • Infectious Disease • Myelodysplastic Syndrome • Myelofibrosis • Novel Coronavirus Disease • Oncology • Pulmonary Disease • ACVR2A • TGFB1

DURABLE CLINICAL BENEFIT WITH ELRITERCEPT (KER-050) TREATMENT: FINDINGS FROM AN ONGOING PHASE 2 TRIAL IN PARTICIPANTS WITH LOWER-RISK MDS (EHA 2024) - P2 | "Of RP2D participants, 56% had HTB and 32% received ≥6 RBC U/8 weeks at baseline. Disease was mostly low-/intermediate-risk per IPSS-R and 7. 9% of cases were reclassified as high- or very high-risk by IPSS-M."

Clinical • P2 data • Anemia • Fatigue • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • Pain • ACVR2A • INHBB • TGFB1

Updated Phase 2 Results of Elritercept in Patients With Transfusion-Dependent Lower-Risk Myelodysplastic Neoplasms (SOHO 2026) - P2 | "Elritercept was well-tolerated and associated with rapid, durable responses in patients with LR-MDS, including those with non-RS and HTB. AE: adverse event, CI: confidence interval, HTB: high transfusion burden, IPSS-R: Revised International Prognostic Scoring System, IWG: International Working Group, LTB: low transfusion burden, RBC: red blood cell, RS: ring sideroblasts, TGF-β: transforming growth factor beta, TI: transfusion independence. This abstract was previously accepted and presented at the 2026 European Hematology Association Annual Meeting; reused with permission."

Clinical • P2 data • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • ACVR2A • TGFB1

Elritercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent–Naïve Adults With Lower-Risk Myelodysplastic Syndromes and Transfusion-Dependent Anemia: The Elrise MDS Phase 3 Study (SOHO 2026) - P3 | "This abstract was previously accepted and presented at the 2026 European Hematology Association Annual Meeting. Reused with permission."

Clinical • P3 data • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • ACVR2A

Elritercept: Regulatory filing for 2L anemia-associated MDS in FY2028-FY2029 (Takeda) - Q1 FY2026 Results

Filing • Hematological Malignancies • Myelodysplastic Syndrome • Myeloproliferative Neoplasm • Oncology

ELRISE MF: A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib (clinicaltrials.gov) - P3 | N=324 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Hematological Disorders • Hematological Malignancies • Myelofibrosis

A Study of TAK-226 for Anemia in Japanese Patients With Lower-Risk Myelodysplastic Syndromes (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting | N=27 ➔ 42

Enrollment change • Enrollment open • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • YY1

ELRISE: A PHASE 3 STUDY OF ELRITERCEPT VS EPOETIN ALFA IN ERYTHROPOIESIS-STIMULATING AGENT (ESA)-NAÏVE ADULTS WITH LOWER-RISK MYELODYSPLASTIC SYNDROMES (MDS) AND TRANSFUSION-DEPENDENT ANEMIA (EHA 2026) - P3 | "Key exclusion criteria include history of thromboembolic events <6 months prior to screening, clinically significant cardiovascular, hepatic or renal issues, BMI ≥40 kg/m 2 and prior therapy with ESAs, hypomethylating agents, luspatercept or immunomodulatory/suppressive agents or procedures (some exceptions applied). Figure 1. Schematic of the ELRISE study design"

Clinical • P3 data • Anemia • Hematological Malignancies • Myelodysplastic Syndrome • ACVR2A

UPDATED PHASE 2 RESULTS OF ELRITERCEPT IN PATIENTS (PTS) WITH TRANSFUSION-DEPENDENT (TD) LOWER-RISK MYELODYSPLASTIC NEOPLASMS (LR-MDS) (EHA 2026) - P2 | "©American Society of Hematology (2025). Reused with permission"

Clinical • P2 data • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • ACVR2A • SF3B1

ELRISE MF: A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib (clinicaltrials.gov) - P3 | N=324 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Anemia • Hematological Disorders • Hematological Malignancies • Myelofibrosis

Targeted treatment of anemia in Myelofibrosis and the impact of jak inhibitors. (PubMed, Expert Opin Pharmacother) - "Unmet needs include standardized endpoints, biologically stratified trials, and validation of hemoglobin and transfusion responses as markers. Strategies like momelotinib plus luspatercept, earlier intervention, and new molecular therapies could turn treatment from palliation to durable control and disease modification."

Journal • Review • Anemia • Hematological Disorders • Inflammation • Myelofibrosis • TGFB1

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (clinicaltrials.gov) - P3 | N=225 | Recruiting | Sponsor: Takeda | N=82 ➔ 225

Enrollment change • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

ELRiSE MDS: A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Takeda | N=84 ➔ 300

Enrollment change • Trial initiation date • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

ELRiSE MDS: A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (clinicaltrials.gov) - P3 | N=51 | Recruiting | Sponsor: Takeda

New P3 trial • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

TAK-226-3001: A phase 3 trial comparing elritercept versus epoetin alfa for treatment of anemia due to lower-risk MDS in ESA-nave adults who require RBC transfusions (clinicaltrialsregister.eu) - P2/3 | N=16 | Not yet recruiting | Sponsor: Takeda Development Center Americas Inc.

New P2/3 trial • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

ELRiSE MDS: A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

ELRiSE MDS: A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Anemia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Oncology

Elritercept: Regulatory filing for 2L anemia-associated MDS in FY2027-FY2029 (Takeda) - Q3 FY2025 Results

Filing • Hematological Malignancies • Myelodysplastic Syndrome • Oncology