Takeda Highlights Oncology and Hematology Research at ASH 2026

Takeda to Highlight Patient-Centered Research in Hematologic Cancers and Blood Disorders at the 68th American Society of Hematology (ASH) Annual Meeting

November 12, 2026

Six MIMRYLO™ (rusfertide) abstracts demonstrate improvement in patient-reported outcomes (PROs) and efficacy and safety across patient subgroups
Oral presentation of Phase 2 elritercept data highlights the potential for durable responses and quality of life improvements in patients with lower-risk myelodysplastic syndrome (MDS)
Post hoc results from a placebo-controlled mezagitamab Phase 2 study indicate an association between higher platelet counts (≥100,000/ml) and health-related quality of life (HRQoL) in participants with chronic/persistent immune thrombocytopenia (ITP)

OSAKA, Japan and CAMBRIDGE, Massachusetts, November 12, 2026 — Takeda (TSE:4502/NYSE:TAK) will present research across a range of hematologic cancers and blood disorders at the 68th American Society of Hematology (ASH) Annual Meeting, taking place December 12–15, 2026, in New Orleans, Louisiana. Data from more than 20 presentations will expand the body of evidence supporting Takeda’s approved and investigational medicines.

“Our data at ASH this year, including new analyses showing how MIMRYLO reduced symptom and treatment burden in polycythemia vera in clinical studies, focus on supporting a more patient-centered treatment experience,” said Awny Farajallah, MD, FACP, Chief Medical Officer at Takeda. “These findings, alongside early insights on our investigational medicines elritercept and mezagitamab, reflect Takeda’s commitment to advancing science and evidence generation across hematologic cancers and blood disorders.”

New Evidence in Hematologic Cancers Prioritizes Patient Experience Alongside Outcomes

Key presentations in oncology will feature new analyses of MIMRYLO™ (rusfertide), a first-in-class hepcidin mimetic approved by the U.S. Food and Drug Administration for the treatment of erythrocytosis in adults with polycythemia vera (PV). The data being presented at ASH include an analysis demonstrating improvement in patient-reported symptoms and post hoc analyses of efficacy and safety outcomes across key patient subgroups. Real-world evidence on the burden of phlebotomy in PV, underscoring the need for alternative therapies, will also be presented.

Additionally, an oral presentation will feature data from the ongoing Phase 2 open-label ascending dose study (NCT04419649) evaluating elritercept (TAK-226), an investigational therapy being studied for anemia associated with myelodysplastic syndrome (MDS) and myelofibrosis (MF). This analysis includes broad lower-risk MDS patient populations, including patients with ring sideroblast (RS)-negative disease and high transfusion burden. These data highlight the potential for elritercept to deliver durable responses and improve quality of life outcomes.

New Findings on Platelet Counts and PROs in a Rare, Immune-mediated Bleeding Disorder

Results from a post hoc analysis of Phase 2 data will highlight an association between platelet counts (≥100,000/µL) and beneficial patient-reported outcomes (PROs) in people living with persistent/chronic primary ITP. ITP is a rare immune-mediated bleeding disorder that causes low platelet counts and an increased risk of bleeding, which can have a debilitating impact on patients. The data are from a multicenter, randomized, double-blind study (NCT04278924) of mezagitamab, an investigational anti-CD38 monoclonal antibody. In the study, PROs were measured using the ITP Patient Assessment Questionnaire (ITP-PAQ), a validated disease-specific instrument to assess symptoms, function and health-related quality of life. Observations from the post hoc analysis indicate that platelet counts ≥100,000/μl were associated with higher scores on ITP-PAQ across multiple domains compared to platelets <30,000/μl, suggesting an association between higher platelet counts and better health-related quality of life.

Elritercept and mezagitamab are investigational medicines that have not been approved by any health authority.

Additional presentations will provide updated evidence for Takeda’s portfolio of approved treatments in lymphoma, leukemia and blood disorders.

MIMRYLO™ (rusfertide) IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

New or Worsening Thrombocytosis: MIMRYLO may increase platelet counts in patients with PV. Platelet counts generally plateaued on treatment by Week 8. After initiating MIMRYLO and during dose modifications, monitor CBC every 2 to 4 weeks or as clinically indicated. Platelet elevations associated with MIMRYLO may require cytoreductive therapy initiation, modification, or MIMRYLO dose modifications or discontinuation.
Injection-Site Reactions: Injection site reactions (including Grade 3 reactions) have been reported in patients treated with MIMRYLO. The most common injection site reactions reported were erythema, pruritus, pain, and swelling. Use ice, topical corticosteroid creams, antihistamines or analgesics, as needed, to treat injection site pain and swelling.
Embryo-Fetal Toxicity: Based on findings from animal reproduction studies, MIMRYLO may cause fetal harm when administered to a pregnant woman. Advise patients to stop taking MIMRYLO if they become pregnant.

ADVERSE REACTIONS

The most common (>15%) adverse reactions were injection site reactions (56%) and anemia (16%).

USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, including impaired iron absorption, advise patients not to breastfeed during treatment with MIMRYLO and for 30 days after the final treatment.
Females and Males of Reproductive Potential
- Pregnancy Testing: Prior to initiating MIMRYLO, pregnancy testing is recommended for females of reproductive potential.
- Contraception: Advise female patients of reproductive potential to use effective contraception during treatment with MIMRYLO and for at least 30 days after the final dose of MIMRYLO.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see MIMRYLO (rusfertide) full Prescribing Information.

About MIMRYLO™ (rusfertide)

MIMRYLO is a first-in-class subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and erythrocytosis. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, MIMRYLO aims to reduce excess red blood cell production and help patients maintain hematocrit control. MIMRYLO is administered once weekly via subcutaneous injection. Protagonist discovered MIMRYLO and led its development through Phase 3. Takeda has exclusive global development and commercialization rights for MIMRYLO.

About Elritercept

Elritercept is a novel investigational TGF-β ligand trap designed to restore effective hematopoiesis by addressing dysregulated activin signaling. Elritercept is currently being evaluated in three ongoing Phase 3 clinical trials: RENEW and ELRiSE MDS in patients with anemia associated with myelodysplastic syndromes (MDS), and ELRiSE MF in patients with anemia associated with myelofibrosis (MF). The U.S. Food and Drug Administration has granted Fast Track designation for the development of elritercept for very low-, low- and intermediate-risk MDS. Takeda holds rights to develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau through an exclusive licensing agreement with Keros Therapeutics.

About Mezagitamab

Mezagitamab is an investigational, fully human anti-CD38 IgG1 monoclonal antibody that depletes cells with high CD38 expression, including plasma cells, plasmablasts and natural killer cells. In ITP, targeting these antibody-producing cells has the potential to reduce pathogenic autoantibody production, which may support improvements in platelet response and platelet counts to clinically meaningful levels. The safety and efficacy of mezagitamab is currently under investigation in a pivotal Phase 3 clinical trial. The U.S. Food and Drug Administration has granted mezagitamab Orphan Drug Designation for the treatment of ITP, Fast Track Designation for chronic/persistent ITP and Breakthrough Designation for the treatment of adult patients with chronic ITP who have had an insufficient response to previous treatment.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

Media Relations

Investor Relations

Christopher O’Reilly

[email protected]

Japanese Media

Tsuyoshi Tada

[email protected]

U.S. and International Media

Emy Gruppo

[email protected]

Stephanie Bostaph Martin

[email protected]

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings-and-security-reports/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

* Six MIMRYLO™ (rusfertide) abstracts demonstrate improvement in patient-reported outcomes (PROs) and efficacy and safety across patient subgroups * Oral presentation of Phase 2 elritercept data highlights the potential for durable responses and quality of life improvements in patients with lower-risk myelodysplastic syndrome (MDS) * Post hoc results from a placebo-controlled mezagitamab Phase 2 study indicate an association between higher platelet counts (≥100,000/ml) and health-related quality of life (HRQoL) in participants with chronic/persistent immune thrombocytopenia (ITP) **OSAKA, Japan and CAMBRIDGE, Massachusetts, November 12, 2026** — Takeda ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/overview/)) will present research across a range of hematologic cancers and blood disorders at the[ 68th American Society of Hematology (ASH) Annual Meeting](https://www.hematology.org/meetings/annual-meeting), taking place December 12–15, 2026, in New Orleans, Louisiana. Data from more than 20 presentations will expand the body of evidence supporting Takeda’s approved and investigational medicines. “Our data at ASH this year, including new analyses showing how MIMRYLO reduced symptom and treatment burden in polycythemia vera in clinical studies, focus on supporting a more patient-centered treatment experience,” said Awny Farajallah, MD, FACP, Chief Medical Officer at Takeda. “These findings, alongside early insights on our investigational medicines elritercept and mezagitamab, reflect Takeda’s commitment to advancing science and evidence generation across hematologic cancers and blood disorders.” ## New Evidence in Hematologic Cancers Prioritizes Patient Experience Alongside Outcomes Key presentations in oncology will feature new analyses of MIMRYLO™ (rusfertide), a first-in-class hepcidin mimetic approved by the U.S. Food and Drug Administration for the treatment of erythrocytosis in adults with polycythemia vera (PV). The data being presented at ASH include an analysis demonstrating improvement in patient-reported symptoms and post hoc analyses of efficacy and safety outcomes across key patient subgroups. Real-world evidence on the burden of phlebotomy in PV, underscoring the need for alternative therapies, will also be presented. Additionally, an oral presentation will feature data from the ongoing Phase 2 open-label ascending dose study (NCT04419649) evaluating elritercept (TAK-226), an investigational therapy being studied for anemia associated with myelodysplastic syndrome (MDS) and myelofibrosis (MF). This analysis includes broad lower-risk MDS patient populations, including patients with ring sideroblast (RS)-negative disease and high transfusion burden. These data highlight the potential for elritercept to deliver durable responses and improve quality of life outcomes. ## New Findings on Platelet Counts and PROs in a Rare, Immune-mediated Bleeding Disorder Results from a post hoc analysis of Phase 2 data will highlight an association between platelet counts (≥100,000/µL) and beneficial patient-reported outcomes (PROs) in people living with persistent/chronic primary ITP. ITP is a rare immune-mediated bleeding disorder that causes low platelet counts and an increased risk of bleeding, which can have a debilitating impact on patients. The data are from a multicenter, randomized, double-blind study (NCT04278924) of mezagitamab, an investigational anti-CD38 monoclonal antibody. In the study, PROs were measured using the ITP Patient Assessment Questionnaire (ITP-PAQ), a validated disease-specific instrument to assess symptoms, function and health-related quality of life. Observations from the post hoc analysis indicate that platelet counts ≥100,000/μl were associated with higher scores on ITP-PAQ across multiple domains compared to platelets <30,000/μl, suggesting an association between higher platelet counts and better health-related quality of life. Elritercept and mezagitamab are investigational medicines that have not been approved by any health authority. Additional presentations will provide updated evidence for Takeda’s portfolio of approved treatments in lymphoma, leukemia and blood disorders. ## MIMRYLO™ (rusfertide) IMPORTANT SAFETY INFORMATION ### WARNINGS AND PRECAUTIONS * **New or Worsening Thrombocytosis:** MIMRYLO may increase platelet counts in patients with PV. Platelet counts generally plateaued on treatment by Week 8. After initiating MIMRYLO and during dose modifications, monitor CBC every 2 to 4 weeks or as clinically indicated. Platelet elevations associated with MIMRYLO may require cytoreductive therapy initiation, modification, or MIMRYLO dose modifications or discontinuation. * **Injection-Site Reactions:** Injection site reactions (including Grade 3 reactions) have been reported in patients treated with MIMRYLO. The most common injection site reactions reported were erythema, pruritus, pain, and swelling. Use ice, topical corticosteroid creams, antihistamines or analgesics, as needed, to treat injection site pain and swelling. * **Embryo-Fetal Toxicity:** Based on findings from animal reproduction studies, MIMRYLO may cause fetal harm when administered to a pregnant woman. Advise patients to stop taking MIMRYLO if they become pregnant. ### ADVERSE REACTIONS The most common (>15%) adverse reactions were injection site reactions (56%) and anemia (16%). #### USE IN SPECIFIC POPULATIONS * **Lactation:** Because of the potential for serious adverse reactions in the breastfed child, including impaired iron absorption, advise patients not to breastfeed during treatment with MIMRYLO and for 30 days after the final treatment. * **Females and Males of Reproductive Potential** * **Pregnancy Testing:** Prior to initiating MIMRYLO, pregnancy testing is recommended for females of reproductive potential. * **Contraception:** Advise female patients of reproductive potential to use effective contraception during treatment with MIMRYLO and for at least 30 days after the final dose of MIMRYLO. To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or [www.fda.gov/medwatch](https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program). Please see MIMRYLO (rusfertide) full [Prescribing Information](https://takeda.info/Mimrylo-Prescribing-Information). ## About MIMRYLO™ (rusfertide) MIMRYLO is a first-in-class subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and erythrocytosis. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, MIMRYLO aims to reduce excess red blood cell production and help patients maintain hematocrit control. MIMRYLO is administered once weekly via subcutaneous injection. Protagonist discovered MIMRYLO and led its development through Phase 3. Takeda has exclusive global development and commercialization rights for MIMRYLO. ## About Elritercept Elritercept is a novel investigational TGF-β ligand trap designed to restore effective hematopoiesis by addressing dysregulated activin signaling. Elritercept is currently being evaluated in three ongoing Phase 3 clinical trials: RENEW and ELRiSE MDS in patients with anemia associated with myelodysplastic syndromes (MDS), and ELRiSE MF in patients with anemia associated with myelofibrosis (MF). The U.S. Food and Drug Administration has granted Fast Track designation for the development of elritercept for very low-, low- and intermediate-risk MDS. Takeda holds rights to develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau through an exclusive licensing agreement with Keros Therapeutics. ## About Mezagitamab Mezagitamab is an investigational, fully human anti-CD38 IgG1 monoclonal antibody that depletes cells with high CD38 expression, including plasma cells, plasmablasts and natural killer cells. In ITP, targeting these antibody-producing cells has the potential to reduce pathogenic autoantibody production, which may support improvements in platelet response and platelet counts to clinically meaningful levels. The safety and efficacy of mezagitamab is currently under investigation in a pivotal Phase 3 clinical trial. The U.S. Food and Drug Administration has granted mezagitamab Orphan Drug Designation for the treatment of ITP, Fast Track Designation for chronic/persistent ITP and Breakthrough Designation for the treatment of adult patients with chronic ITP who have had an insufficient response to previous treatment. ## About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit[ www.takeda.com](https://www.takeda.com/). ## Media Relations ### Investor Relations Christopher O’Reilly [[email protected]](mailto:[email protected]) ### Japanese Media Tsuyoshi Tada [[email protected]](mailto:[email protected]) ### U.S. and International Media Emy Gruppo [[email protected]](mailto:[email protected]) Stephanie Bostaph Martin [[email protected]](mailto:[email protected]) ## Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. ## Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects”, “forecasts”, “outlook” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including drug pricing, tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: [https://www.takeda.com/investors/sec-filings-and-security-reports/](https://www.takeda.com/investors/sec-filings-and-security-reports/) or at [www.sec.gov](https://www.sec.gov/). Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. ## Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.