Incyte to Present New Data Highlighting Progress Across its Hematology Portfolio at ASH 2026

Incyte (Nasdaq:INCY) today announced that new data highlighting progress across its hematology portfolio will be presented across more than 30 abstracts at the 2026 American Society of Hematology (ASH) Annual Meeting, to beheld December 12 – 15, 2026, in New Orleans.

“Our ASH presentations demonstrate meaningful progress across our Hematology portfolio to advance novel treatment approaches for people with serious hematologic conditions,” said Pablo J. Cagnoni, M.D., President, Incyte and Global Head of Research and Development. "We are particularly encouraged by the continued clinical progress of INCA033989 in myelofibrosis (MF) and essential thrombocythemia (ET) and the data for latarcibart in von Willebrand disease (VWD) - data that support our goal of advancing differentiated medicines with the potential to meaningfully improve outcomes for patients."

Details on key data presentations at ASH include:

Oral Presentations

INCA033989 (mutCALR)

In JAK-Inhibitor Naive Patients with Myelofibrosis, Mutant CALR-Specific Monoclonal Antibody INCA033989 Was Well Tolerated and Achieved Robust Spleen, Symptom, and Anemia Responses in Phase 1 Studies
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: MF and SM: Emerging Targets and Treatment Strategies [December 12, 2026; 4:00 – 4:15 p.m. CT, 5:00 – 5:15 p.m. ET]. Publication #409.)

Mutant CALR-Specific Monoclonal Antibody INCA033989 Produced Molecular Responses and Restored Normal Hematopoiesis in Patients with Essential Thrombocythemia in Phase 1 Studies
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: ET and PV: Moving Beyond Conventional Therapy [December 14, 2026; 4:45 – 5:00 p.m. CT, 5:45 – 6:00 p.m. ET]. Publication #1034.)

Latarcibart (VGA039)

Long-Term Efficacy and Safety of a Novel Protein S Antibody for Prophylaxis in Adolescents and Adults with Von Willebrand Disease: Results from a Phase 1/2 Open-Label Extension Study of Latarcibart (VGA039)
(Session Title: 23. Disorders of Coagulation, Bleeding, or Fibrinolysis, Excluding Congenital Hemophilias: Clinical and Epidemiological [December 14, 2026; 3:30 – 3:45 p.m. CT, 4:30 – 4:45 p.m. ET]. Publication #880.)

INCB203954 (JAK2V617F)

Preclinical Characterization of INCB203954, a Next-Generation JAK2V617F-Selective Inhibitor with Potential for Disease-Modifying Activity in Myeloproliferative Neoplasms
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Triple S: MPN Goes Spatial, Selective and to the Cell Surface! [December 13, 2026; 5:00 – 5:15 p.m. CT, 6:00 – 6:15 p.m. ET]. Publication #675.)

Tafasitamab (Monjuvi^®)

Phase 3 Study (frontMIND) of Tafasitamab Plus Lenalidomide and R-CHOP versus R-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Clinical Outcomes Among Patients with Partial Metabolic Response at End of Treatment
(Session Title: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Novel Study Designs and New Immunotherapy Approaches [December 12, 2026; 4:30 – 4:45 p.m. CT, 5:30 – 5:45 p.m. ET]. Publication #405.)

Poster Presentations

INCA033989 (mutCALR)

Analytical Performance of the QIAGEN HemeOnc Next-Generation Sequencing Panel for CALR Exon 9 Frameshift Mutation Detection in Myeloproliferative Neoplasms
(Session Title: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4338.)

Mutant CALR-Specific Monoclonal Antibody INCA033989 Improved Disease Burden, Including Splenomegaly, Symptoms, and Anemia, as Monotherapy or in Combination with Ruxolitinib in Patients with Myelofibrosis and Relapsed, Refractory, or Suboptimal Response to Prior Therapy in a Phase 1 Study
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5576.)

Trial in Progress: EXCALIBUR-ET2, an International, Randomized Phase 3 Trial of the Mutant Calreticulin-Directed Monoclonal Antibody INCA033989 vs Best Available Therapy in Patients with High-Risk Essential Thrombocythemia After Inadequate Response to Cytoreductive Therapy
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5526.)

Latarcibart (VGA039)

Characterization of Burden of Illness from Long-Term Frequent Bleeding in Patients with Von Willebrand Disease Using a Large United States Real-World Dataset
(Session Title: 323. Disorders of Coagulation, Bleeding, or Fibrinolysis, Excluding Congenital Hemophilias: Clinical and Epidemiological: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3055.)

Axatilimab (Niktimvo^®)

Axatilimab Demonstrated Clinical Benefit without Baseline Corticosteroid Use in Patients with Chronic Graft-versus-Host Disease: A Subgroup Analysis of the AGAVE-201 Trial
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I [December 12, 2026; 5:30 – 7:30 p.m. CT, 6:30 – 8:30 p.m. ET]. Publication #2478.)

Molecular Signatures Associated with Clinical Improvement in Patients with Chronic Graft-versus-Host Disease Receiving Axatilimab: A Correlation Analysis from AGAVE-201
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4252.)

Long-Term Efficacy and Safety of Axatilimab Among Patients with Chronic Graft-versus-Host Disease in AGAVE-201
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5995.)

Immune Reprogramming with Axatilimab: CSF-1R–dependent Myeloid Modulation and Reduced CD4⁺ T-Cell Activation in Chronic Graft-versus-Host Disease
(Session Title: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #6012.)

INCA041798 (mutCALR)

Discovery of INCA041798, a Next-Generation mutCALR-Targeting Antibody with Extended Half-Life and Potent Activity Across Clinically Relevant mutCALR Variants in Myeloproliferative Neoplasms
(Session Title: 631. Myeloproliferative Syndromes and Chronic Myeloid Leukemia: Basic and Translational: Poster II [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5481.)

Ruxolitinib (Jakafi^®)

Contemporary Real-World Clinical Characteristics and Treatment Patterns of 1555 Patients with Myelofibrosis in the United States
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4597.)

Longitudinal Dynamics and Clinical Correlations of JAK2V617F and CALR Exon 9 Mutations in Patients with Myeloproliferative Neoplasms
(Session Title: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3816.)

Progressive Polycythemia Vera: A Proposed New Category to Define a Clinically Relevant Population
(Session Title: 908. Outcomes Research: Myeloid Malignancies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4605.)

Tafasitamab (Monjuvi^®)

Tafasitamab Plus Lenalidomide and Rituximab for Relapsed/Refractory Follicular Lymphoma (R/R FL) in the United States Real-World Setting
(Session Title: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I [December 12, 2026; 5:30 – 7:30 p.m. CT, 6:30 – 8:30 p.m. ET]. Publication #2755.)

The CAR-T Funnel: AI-Assisted Mapping of Patient Attrition and Barriers Across the Second-Line CAR-T Pathway in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
(Session Title: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster I [December 12, 2026; 5:30 – 7:30 p.m. CT, 6:30 – 8:30 p.m. ET]. Publication #2766.)

Phase 3 Study (frontMIND) of Tafasitamab and Lenalidomide Plus R-CHOP vs R-CHOP in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma: Clinical Characteristics and Outcomes by Age
(Session Title: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3652.)

A Comprehensive Indirect Treatment Comparison of Tafasitamab Plus Lenalidomide and Rituximab vs Epcoritamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma
(Session Title: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3545.)

Addition of Tafasitamab (Tafa) to Lenalidomide and Rituximab (R2) Shows Activity in Patients (Pts) with Molecularly Defined High-Risk Relapsed or Refractory Follicular Lymphoma (R/R FL): Results from a Global, Randomized, Phase 3 Study (inMIND)
(Session Title: 621. Lymphomas: Translational – Molecular and Genetic: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3498.)

Real-World Effectiveness and Safety of CAR-T Therapy After Tafasitamab in US Patients with Relapsed/Refractory DLBCL
(Session Title: 906. Outcomes Research: Lymphoid Malignancies Excluding Plasma Cell Disorders: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4487.)

Tafasitamab-Lenalidomide Activity in Elderly Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Ineligible for Autologous Stem Cell Transplantation: Patient-Reported Health Status as a Prognostic Factor in the PRO-MIND Study
(Session Title: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II [December 13, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3655.)

Tafasitamab and Lenalidomide Added to R-CHOP versus R-CHOP Induces Deeper Molecular Responses That Predict Outcomes in Patients with Previously Untreated Diffuse Large B-Cell Lymphoma
(Session Title: 621. Lymphomas: Translational – Molecular and Genetic: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #5254.)

Broader Modulation of B-Cell Biology by Tafasitamab Compared with Rituximab: Implications for Autoimmune Disease
(Session Title: 203. Lymphocytes and Acquired or Congenital Immunodeficiency Disorders: Poster III [December 14, 2026; 6:00 – 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #4741.)

Lenalidomide Relative Dose Intensity and Postlandmark Outcomes in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with Tafasitamab-Lenalidomide: An Exploratory Real-World Analysis from the PRO-MIND Study
(Session Title: 627. Aggressive Lymphomas: Targeted and Pharmacologic Therapies: Poster II [December 13, 2026; 6:00 - 8:00 p.m. CT, 7:00 – 9:00 p.m. ET]. Publication #3657.)

More information regarding the ASH 2026 Annual Meeting can be found at: https://www.hematology.org/meetings/annual-meeting.

Analyst Event and Webcast
The data presented at ASH will be discussed at an in-person and virtual analyst and investor event on Saturday, December 12, 2026, from 7:30 – 9:00 p.m. CT (8:30 – 10:00 p.m. ET). To register for the event, please visit https://incyte-investor-event-ash-2026.open-exchange.net/registration.

The event will be webcast and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com; the replay will be available for 30 days.

About Latarcibart (VGA039)
Latarcibart (VGA039) is an investigational monoclonal antibody therapy with a novel mechanism of action that targets Protein S, with dual actions promoting platelet attachment and enhancing fibrin deposition to restore hemostasis. Latarcibart has the potential to be a universal prophylactic therapy for numerous bleeding disorders, starting with all types of von Willebrand disease (VWD) and bleeding sites. As a subcutaneously self-administered investigational antibody therapy with a once monthly dosing regimen, latarcibart has the potential to improve bleeding outcomes, convenience, and quality of life for patients.

Latarcibart has received Breakthrough Therapy, Fast Track, orphan drug and rare pediatric disease designations from the U.S. Food and Drug Administration (FDA). Latarcibart has advanced into the Phase 3 VIVID-6 study (NCT07115004), a global single arm cross-over study to investigate safety and efficacy of the subcutaneous administration of latarcibart as prophylaxis for bleeding in patients with every type of VWD, including those with a high disease burden.

Incyte acquired VGA039 (latarcibart) in July 2026 as part of its acquisition of Vega Therapeutics, Inc., a wholly owned subsidiary of Star Therapeutics LLC.

About Niktimvo™ (axatilimab-csfr)
Niktimvo™ (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway.

Niktimvo is a trademark of Incyte.

All other trademarks are the property of their respective owners.

About Jakafi^® (ruxolitinib)
Jakafi^® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is a registered trademark of Incyte.

About Jakafi XR™ (ruxolitinib) Extended-Release Tablets
Jakafi XR™ (ruxolitinib) extended-release tablets are a once-daily (QD) formulation of ruxolitinib, a first-in-class JAK1/JAK2 inhibitor, approved by the U.S. FDA for the treatment of intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults; polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older; and chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

It is not known if Jakafi XR is safe or effective in children for treatment of myelofibrosis or polycythemia vera.

Jakafi XR and the Jakafi XR logo are trademarks of Incyte.

About Monjuvi^® (tafasitamab-cxix)/Minjuvi^® (tafasitamab)
Monjuvi^® (tafasitamab-cxix)/Minjuvi^® (tafasitamab) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb^® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi is approved for use in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received approval in the U.S. in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional marketing authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, Minjuvi is approved for use in Europe in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

In Japan, Minjuvi is approved for use in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory FL (2L+ FL).

XmAb is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

About Incyte^®
Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Incyte Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the data to be presented by Incyte at the American Society of Hematology Annual Meeting 2026 and Incyte’s expectations regarding the significance of such data; the potential safety, efficacy, clinical utility and therapeutic potential of Incyte's products and product candidates, including INCA033989 and latarcibart (VGA039); the potential for Incyte's investigational therapies to improve patient outcomes; Incyte's ongoing and planned clinical development programs; and Incyte’s aspirations and goals as set forth under the heading “About Incyte”.

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including Incyte’s ability to demonstrate the efficacy and safety of its products and product candidates; the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended September 30, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

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