MIMRYLO Included as PV Treatment Option in NCCN Guidelines for MPNs

Takeda’s Rusfertide (MIMRYLO™) Included as Category 1 Treatment for Polycythemia Vera in National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Myeloproliferative Neoplasms

September 21, 2026

MIMRYLO, a First-in-Class Medicine Approved by the Food and Drug Administration (FDA) for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV), Is Available in the U.S.
NCCN Recommendation is Based on Clinical Data from Phase 3 VERIFY Study, in Which MIMRYLO Plus Current Therapy More Than Doubled Clinical Response Rates, as Well as Efficacy Data from Phase 2 REVIVE
MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue

OSAKA, Japan and CAMBRIDGE, Massachusetts, September 21, 2026 – Takeda (TSE:4502/NYSE:TAK) announced that rusfertide (MIMRYLO™) is the only treatment to be recommended as a Category 1 option across both low- and high-risk polycythemia vera (PV), a blood cancer, in the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms (Version 3.2026), updated on September 18, 2026.¹

MIMRYLO was approved by the U.S. Food and Drug Administration (FDA) on August 28 for the treatment of erythrocytosis in adults with PV. It is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction (erythrocytosis) to control hematocrit levels, which is the ratio of red blood cells to the total amount of blood in the body. Maintaining hematocrit levels consistently below 45% can prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, pruritus (itching), difficulty concentrating and night sweats.² Yet, an estimated 78% of patients still experience uncontrolled hematocrit despite treatment, including phlebotomy and cytoreductive therapies.³ Patients with PV experiencing uncontrolled hematocrit have a four times higher risk of cardiovascular death or major cardiovascular events.²

“The inclusion of MIMRYLO in the NCCN Guidelines is a meaningful milestone for patients with PV, who have long needed more options,” said Rushi Potdar, M.D., chief medical officer and head of global medical affairs, Global Oncology Business Unit, Takeda. “MIMRYLO’s availability in the U.S. marks a potential shift in the treatment paradigm for PV, giving clinicians and patients access to a novel therapy with the potential to help maintain hematocrit control, which the majority of patients being treated for PV do not achieve today.”

The NCCN Guidelines are evidence-based recommendations developed by multidisciplinary panels of experts from leading cancer centers. They provide regularly updated guidance on cancer screening, diagnosis, treatment, supportive care and disease management. The NCCN Guidelines are widely used by healthcare professionals, patients and their families and payers to inform cancer-care decisions and help promote effective, equitable, accessible and high-quality care.

NCCN Guidelines inclusion was based on two late-stage pivotal studies that included over 360 patients with PV, showing that MIMRYLO met key efficacy endpoints and demonstrated a favorable safety profile. These studies included the Phase 3 global randomized VERIFY study (NCT05210790), as well as the Phase 2 REVIVE study (NCT04057040). In the VERIFY study, patients receiving MIMRYLO plus current therapy demonstrated a higher response rate compared to placebo plus current standard of care. This included hematocrit control, a reduction in the need for phlebotomy and improvement in pre-specified patient-reported outcome measures of fatigue as measured by PROMIS Fatigue Short Form 8a and symptom burden as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Version 4.0. MIMRYLO was generally well-tolerated through 52 weeks of treatment in the VERIFY trial. The most common treatment-emergent adverse events in MIMRYLO-treated patients were injection site reactions and anemia. Learn more about the Phase 3 data results here.

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™

MIMRYLO™ is a first-in-class subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and erythrocytosis. MIMRYLO is U.S. Food and Drug Administration approved for the treatment of erythrocytosis in adults with PV. 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 and has been generally well-tolerated in clinical trials to date. Protagonist discovered MIMRYLO and led its development through Phase 3. Takeda now has exclusive global development and commercialization rights for MIMRYLO.

About VERIFY

The Phase 3 VERIFY study (NCT05210790) is an ongoing, three-part, global, randomized, placebo-controlled study evaluating MIMRYLO in 293 patients with polycythemia vera over a 156-week period, with treatment extension for participants who are continuing to derive benefit from MIMRYLO beyond the 156-week treatment period. The study is evaluating the efficacy and safety of once-weekly, subcutaneously self-administered MIMRYLO in patients with uncontrolled hematocrit who are phlebotomy-dependent despite current standard of care treatment, which could include phlebotomy, hydroxyurea, interferon and/or ruxolitinib.

The primary endpoint of the study was the proportion of patients achieving a response during Weeks 20-32, which was defined as the absence of “phlebotomy eligibility.” To meet phlebotomy eligibility, patients in the study were required to have: confirmed hematocrit ≥45% that was ≥3% higher than their baseline hematocrit value, or hematocrit ≥48%. Key secondary endpoints evaluated at Week 32 included mean number of phlebotomies, proportion of patients maintaining hematocrit <45%, mean change in fatigue score as measured by PROMIS Fatigue Short Form 8a and total symptom burden as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Version 4.0.

All patients have completed their participation in the randomized, placebo-controlled portion of the study evaluating the efficacy and safety of MIMRYLO plus current standard of care versus placebo plus current standard of care and are now in the open-label portions of the study.

About REVIVE

The Phase 2 REVIVE study (NCT04057040) evaluated MIMRYLO in adult patients with polycythemia vera and consisted of three parts, including 70 patients in the dose-finding Part 1 (28 weeks), 59 patients in the blinded, placebo-controlled, randomized withdrawal Part 2 (13 weeks) and 58 patients in the Part 3 open-label expansion (52 weeks).

About Polycythemia Vera (PV)

Polycythemia vera (PV) is a chronic blood cancer characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of less than 45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, difficulty in concentrating, night sweats and pruritus.

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.

Takeda 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.

Takeda 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 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.

Takeda 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.

Contacts

Investor Relations

Christopher O’Reilly

[email protected]

Japanese Media

Tsuyoshi Tada

[email protected]

U.S. and International Media

Lauren Sherman

[email protected]

References

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms V.3.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed September 18, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Marchioli R, et al. Cardiovascular events and intensity of treatment in polycythemia vera. N Engl J Med 2013;368:22:33.
Verstovsek S, et al. Real-world treatments and thrombotic events in polycythemia vera patients in the USA. Ann Hematol2023;102:571-58.

* MIMRYLO, a First-in-Class Medicine Approved by the Food and Drug Administration (FDA) for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV), Is Available in the U.S. * NCCN Recommendation is Based on Clinical Data from Phase 3 VERIFY Study, in Which MIMRYLO Plus Current Therapy More Than Doubled Clinical Response Rates, as Well as Efficacy Data from Phase 2 REVIVE * MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue **OSAKA, Japan and CAMBRIDGE, Massachusetts, September 21, 2026 –** Takeda ([TSE:4502/NYSE:TAK](https://www.takeda.com/investors/overview/)) announced that rusfertide (MIMRYLO™) is the only treatment to be recommended as a Category 1 option across both low- and high-risk polycythemia vera (PV), a blood cancer, in the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms (Version 3.2026), updated on September 18, 2026.1 MIMRYLO was approved by the U.S. Food and Drug Administration (FDA) on August 28 for the treatment of erythrocytosis in adults with PV. It is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction (erythrocytosis) to control hematocrit levels, which is the ratio of red blood cells to the total amount of blood in the body. Maintaining hematocrit levels consistently below 45% can prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, pruritus (itching), difficulty concentrating and night sweats.2 Yet, an estimated 78% of patients still experience uncontrolled hematocrit despite treatment, including phlebotomy and cytoreductive therapies.3 Patients with PV experiencing uncontrolled hematocrit have a four times higher risk of cardiovascular death or major cardiovascular events.2 “The inclusion of MIMRYLO in the NCCN Guidelines is a meaningful milestone for patients with PV, who have long needed more options,” said Rushi Potdar, M.D., chief medical officer and head of global medical affairs, Global Oncology Business Unit, Takeda. “MIMRYLO’s availability in the U.S. marks a potential shift in the treatment paradigm for PV, giving clinicians and patients access to a novel therapy with the potential to help maintain hematocrit control, which the majority of patients being treated for PV do not achieve today.” The NCCN Guidelines are evidence-based recommendations developed by multidisciplinary panels of experts from leading cancer centers. They provide regularly updated guidance on cancer screening, diagnosis, treatment, supportive care and disease management. The NCCN Guidelines are widely used by healthcare professionals, patients and their families and payers to inform cancer-care decisions and help promote effective, equitable, accessible and high-quality care. NCCN Guidelines inclusion was based on two late-stage pivotal studies that included over 360 patients with PV, showing that MIMRYLO met key efficacy endpoints and demonstrated a favorable safety profile. These studies included the Phase 3 global randomized VERIFY study (NCT05210790), as well as the Phase 2 REVIVE study (NCT04057040). In the VERIFY study, patients receiving MIMRYLO plus current therapy demonstrated a higher response rate compared to placebo plus current standard of care. This included hematocrit control, a reduction in the need for phlebotomy and improvement in pre-specified patient-reported outcome measures of fatigue as measured by PROMIS Fatigue Short Form 8a and symptom burden as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Version 4.0. MIMRYLO was generally well-tolerated through 52 weeks of treatment in the VERIFY trial. The most common treatment-emergent adverse events in MIMRYLO-treated patients were injection site reactions and anemia. Learn more about the Phase 3 data results [here](https://www.takedaoncology.com/newsroom/news-releases/2025/ash-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™ MIMRYLO™ is a first-in-class subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and erythrocytosis. MIMRYLO is U.S. Food and Drug Administration approved for the treatment of erythrocytosis in adults with PV. 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 and has been generally well-tolerated in clinical trials to date. Protagonist discovered MIMRYLO and led its development through Phase 3. Takeda now has exclusive global development and commercialization rights for MIMRYLO. ## About VERIFY The Phase 3 VERIFY study (NCT05210790) is an ongoing, three-part, global, randomized, placebo-controlled study evaluating MIMRYLO in 293 patients with polycythemia vera over a 156-week period, with treatment extension for participants who are continuing to derive benefit from MIMRYLO beyond the 156-week treatment period. The study is evaluating the efficacy and safety of once-weekly, subcutaneously self-administered MIMRYLO in patients with uncontrolled hematocrit who are phlebotomy-dependent despite current standard of care treatment, which could include phlebotomy, hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study was the proportion of patients achieving a response during Weeks 20-32, which was defined as the absence of “phlebotomy eligibility.” To meet phlebotomy eligibility, patients in the study were required to have: confirmed hematocrit ≥45% that was ≥3% higher than their baseline hematocrit value, or hematocrit ≥48%. Key secondary endpoints evaluated at Week 32 included mean number of phlebotomies, proportion of patients maintaining hematocrit <45%, mean change in fatigue score as measured by PROMIS Fatigue Short Form 8a and total symptom burden as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Version 4.0. All patients have completed their participation in the randomized, placebo-controlled portion of the study evaluating the efficacy and safety of MIMRYLO plus current standard of care versus placebo plus current standard of care and are now in the open-label portions of the study. ## About REVIVE The Phase 2 REVIVE study (NCT04057040) evaluated MIMRYLO in adult patients with polycythemia vera and consisted of three parts, including 70 patients in the dose-finding Part 1 (28 weeks), 59 patients in the blinded, placebo-controlled, randomized withdrawal Part 2 (13 weeks) and 58 patients in the Part 3 open-label expansion (52 weeks). ## About Polycythemia Vera (PV) Polycythemia vera (PV) is a chronic blood cancer characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of less than 45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, difficulty in concentrating, night sweats and pruritus. ## 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/). ## Takeda 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. ## Takeda 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 [https://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. ## Takeda 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. ## Contacts ### Investor Relations Christopher O’Reilly [[email protected]](mailto:[email protected]) ### Japanese Media Tsuyoshi Tada [[email protected]](mailto:[email protected]) ### U.S. and International Media Lauren Sherman [[email protected]](mailto:[email protected]) ## References 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myeloproliferative Neoplasms V.3.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed September 18, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Marchioli R, et al. *Cardiovascular events and intensity of treatment in polycythemia vera*. N Engl J Med 2013;368:22:33. 3. Verstovsek S, et al. *Real-world treatments and thrombotic events in polycythemia vera patients in the USA*. Ann Hematol2023;102:571-58.