BeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal Cancer

 SAN CARLOS, Calif. -

Findings provide further evidence of overall survival benefit of TEVIMBRA plus ZIIHERA and chemotherapy regimen in HER2+ GEA

ZIIHERA plus chemotherapy demonstrated statistically significant overall survival benefit at second interim analysis of HERIZON-GEA-01 trial

 

(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced positive topline results from the second interim analysis (IA2) of the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), in combination with chemotherapy, with and without TEVIMBRA® (tislelizumab), as first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). At IA2, ZIIHERA plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with trastuzumab plus chemotherapy, meeting the remaining primary endpoint analysis of the study.

IA2 also provided longer follow-up data for the TEVIMBRA plus ZIIHERA and chemotherapy regimen, demonstrating an improved OS hazard ratio, continued durable outcomes, and a generally manageable safety profile. These results reinforce findings from IA1, in which the regimen met the progression-free survival (PFS) and OS endpoints, with the overall survival benefit observed across PD-L1 and HER2+ expression levels.

Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne Medicines, said:

“Today’s results, coming just days after FDA approval of the HERIZON-GEA-01 regimens, add to a series of important milestones demonstrating their potential to transform the treatment of HER2-positive GEA. We now have compelling Phase 3 evidence of statistically significant and clinically meaningful overall survival results across both HERIZON-GEA experimental arms, reinforcing the opportunity to improve outcomes for patients beginning first-line treatment. This latest result is also particularly meaningful for BeOne given our rights to ZIIHERA across much of Asia, where the burden of gastroesophageal cancer is substantial, as we work to bring these treatment options to more patients around the world.”

Recent FDA approval establishes HERIZON-GEA-01 regimen as potential new standard of care

On August 25 2026, the U.S. Food and Drug Administration (FDA) approved supplemental Biologics License Applications (sBLAs) for both ZIIHERA and TEVIMBRA in combination with chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2+ gastric, gastroesophageal junction, or esophageal adenocarcinoma, making it the first FDA-approved immunotherapy-based regimen in this setting to demonstrate median OS exceeding two years, regardless of PD-L1 status. The approval was based on results from IA1 of HERIZON-GEA-01, which were published in The New England Journal of Medicine earlier this year.

The safety profile of ZIIHERA plus chemotherapy and TEVIMBRA plus ZIIHERA and chemotherapy at IA2 was generally consistent with that of IA1 and the known safety profiles of the individual treatment components, with no new safety signals identified.

The results from IA2 have been submitted for presentation at a major medical meeting in the fourth quarter of 2026.

About the HERIZON-GEA-01 Phase 3 Trial

HERIZON-GEA-01 (NCT05152147) is a global, randomized, open-label Phase 3 trial, conducted jointly with Jazz Pharmaceuticals, to evaluate and compare the efficacy and safety of ZIIHERA plus chemotherapy, with and without TEVIMBRA, to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for adult patients with advanced/metastatic HER2+ GEA. The trial randomized 914 patients from approximately 300 trial sites in more than 30 countries. Patients for this trial had unresectable locally advanced, recurrent or metastatic HER2+ GEA (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Patients were randomized to the three trial arms: ZIIHERA in combination with chemotherapy and TEVIMBRA; ZIIHERA in combination with chemotherapy; and trastuzumab plus chemotherapy. The trial evaluated dual primary endpoints, PFS per blinded independent central review (BICR) and OS.

About ZIIHERA (zanidatamab-hrii)

ZIIHERA (zanidatamab) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab-jsgr)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the cornerstone of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved for various solid tumors (see prescribing information) in over 50 countries, and more than 2 million patients have been treated globally.

Select Important Safety Information

Serious and sometimes fatal adverse reactions occurred with TEVIMBRA treatment. Warnings and Precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

The most common adverse reactions (≥20%), including lab abnormalities, in patients receiving TEVIMBRA + zanidatamab + chemotherapy were diarrhea, nausea, anemia, decreased appetite, vomiting, hypokalemia, fatigue, rash, decreased neutrophil count, decreased platelet count, peripheral neuropathy, infusion-related reaction, and increased AST.

Please see full U.S. Prescribing Information including the U.S. Medication Guide.

About BeOne

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

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 the potential of the HERIZON-GEA-01 regimens to transform the treatment of HER2-positive GEA; the presentation of results from IA2 at a future medical meeting; the potential of TEVIMBRA across multiple tumor types and disease settings; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom site.

1 ZIIHERA (zanidatamab-hrii) Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc.

 

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Investor Contact

Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact

Kyle Blankenship

+1 667-351-5176

media@beonemed.com

 

Rigaku and Tohoku University Establish a New Research Institute for X-Ray Metrology

 TOKYO - Friday, 28. August 2026 AETOSWire  

(BUSINESS WIRE) -- Rigaku Corporation, a group company of Rigaku Holdings and a global solutions partner for X-ray analytical systems (Head Office: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), and Tohoku University (Sendai, Miyagi; President: Teiji Tominaga; “Tohoku University”) have established the Rigaku-Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits (the “Institute”) at Tohoku University on August 1, 2026. The Institute will advance X-ray metrology technology, develop new metrology methods, and foster the next generation of researchers through an initial three-year collaboration, with the possibility of extension based on its achievements.

As semiconductors become smaller, more multilayered, and incorporate a wider range of materials, manufacturing processes are becoming increasingly complex. X-ray metrology technology is essential for high-precision, non-destructive analysis needed for supporting stable mass production, yet conventional techniques are reaching their limits in areas such as evaluation of microstructures and accurate structural analysis in the depth direction. Addressing these challenges requires new metrology technologies, including soft X-rays (X-rays with longer wavelengths and lower energy than conventional X-rays), as well as stronger capabilities built in collaboration with synchrotron radiation facilities.

In addition, fostering professionals who can systematically understand advanced X-ray metrology and apply it in both industry and research has become increasingly important.

To address these two challenges of technology and human resources, Tohoku University, home to the next-generation synchrotron radiation facility NanoTerasu and a leader in information science, and Rigaku, with its expertise and a proven track record in X-ray metrology, have established a new institute. Under the banner “Beyond The Limits,” the Institute will integrate technological innovation and talent development to push beyond the current limits of X-ray metrology.

The Institute seeks to focus on three key goals:

1. Advancement of X-ray Metrology Technology

The Institute will develop microstructure metrology technologies by leveraging NanoTerasu’s strengths in the soft X-ray field, integrating Tohoku University’s expertise in information science with Rigaku’s technical know-how to advance data analysis. It aims to establish a technological foundation that meets increasingly sophisticated metrology and analysis needs.

2. Promotion of Collaborative Research

The Institute will pursue collaborative research across a broad range of fields that require X-ray metrology, including challenges that cannot be addressed with conventional technologies.

3. Training and Support for Next-Generation Researchers and Engineers

The Institute will provide systematic education in X-ray metrology technology, from its fundamentals to its applications to new materials and structures, with the aim of introducing credit-bearing courses. It aims to cultivate researchers and engineers who can contribute to both industry and academia. In addition, the Rigaku Scholarship System will provide scholarships to graduate students conducting X-ray-related research, supporting their academic research toward a degree thesis as well as its application to practical metrology technologies.

During its initial three-year term, the Institute will focus on achieving the goals of its joint research plan. Priority will be given to the practical application of soft X-ray metrology for semiconductors and the advancement of data analysis technologies through information science. Building on these achievements, the Institute will expand its research to broader fields, including electronic and functional materials, where precise characterization of microstructures and material states is essential.

By cultivating researchers and engineers with the skills to contribute to both industry and academia, the Institute aims to foster a cycle of knowledge exchange in X-ray metrology and help establish a sustainable foundation for innovation.

“The driving force behind Rigaku’s growth has been our ability to provide optimal solutions using X-ray technology whenever new metrology targets have emerged,” says Kazuhiko Omote, General Manager, X-ray Research Laboratory, Rigaku Corporation (Chief Operations Officer and Specially Appointed Professor, the Institute) “Although more than 130 years have passed since their discovery and the fundamental principles of X-rays appear to have been fully elucidated, I am convinced that X-rays still hold numerous possibilities that have yet to be revealed. Unlocking these possibilities will require the contributions of the next generation. At the Institute, we aim to explore uncharted territory in collaboration with Tohoku University’s academic expertise, while nurturing the next generation of talent to take on these challenges.”

“X-ray metrology is a fundamental technology that supports a wide range of fields, including semiconductors, materials, and life sciences,” says Daichi Chiba, Director, International Center for Synchrotron Radiation Innovation Smart, Tohoku University (Operations Support Officer, the Institute). “Continued innovation is essential to unlock its full potential. The Institute aims not only to serve as a platform connecting Rigaku’s advanced technical capabilities with Tohoku University’s research infrastructure, including NanoTerasu, but also to create an environment where diverse ideas inspire one another across disciplines, generations, and industry-academia boundaries, generating new ideas and technologies. True to its name, “Beyond The Limits,” we hope to break free from existing frameworks and, together with the next generation of researchers and engineers, shape the future of X-ray metrology technology. We hope this Institute will become a launchpad for innovation that pushes beyond today’s technological limits.”

Overview of the Co-Creation Research Institute

Name: Rigaku–Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits

 

Activities: Advancing X-ray metrology, developing new metrology methods, and fostering the next generation of researchers

 

Management Structure:

(1) Chief Operations Officer and Specially Appointed Professor:

Kazuhiko Omote

General Manager, X-ray Research Laboratory, Rigaku Corporation

(2) Operations Support Officer:

Daichi Chiba

Director, International Center for Synchrotron Radiation Innovation Smart, Tohoku University

Professor, Nano Materials Function Creation Smart lab

 

Location: Tohoku University

 

Period of Operation: August 1, 2026 – July 31, 2029

The period may be extended based on the outcomes achieved.

About the Rigaku Group

Since its establishment in 1951, the engineering professionals of the Rigaku group have been dedicated to benefiting society with leading-edge technologies, notably including its core fields of X-ray and thermal analysis. With a market presence in 136 countries and regions and some 2,000 employees from 9 global operations, Rigaku is a solution partner in industry and research analysis institutes. Our overseas sales ratio has reached approximately 70% while sustaining an exceptionally high market share in Japan. Together with our customers, we continue to develop and grow. As applications expand from semiconductors, electronic materials, batteries, environment, resources, energy, life science to other high-tech fields, Rigaku realizes innovations “To Improve Our World by Powering New Perspectives.”

For details, please visit: rigaku-holdings.com/english

 

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Press Contact:

Sawa Himeno

Director, Communications Dept., Rigaku Holdings Corporation

prad@rigaku.co.jp　

New Auction Record Set as Falcon Sells for AED 1.5 Million at ADIHEX 2026

 Qarmousha Pure Ultra White falcon sells for AED 1.5 million at the Abu Dhabi International Hunting and Equestrian Exhibition 2026 (ADIHEX) falcon auction

 

Under the patronage of His Highness Sheikh Hamdan bin Zayed Al Nahyan, Ruler’s Representative in Al Dhafra Region and Chairman of the Emirates Falconers’ Club, the fifth auction held as part of the 23rd edition of the Abu Dhabi International Hunting and Equestrian Exhibition (ADIHEX) 2026 attracted remarkable turnout, culminating in the sale of a Qarmousha Pure Ultra White falcon for AED 1.5 million (USD 408,000). The sale marks the highest price achieved at any auction during this year's edition of the exhibition.

This forms part of the largest auction programme in the exhibition's history, held under the theme "A Legacy of Pride", organised by ADNEC Group, a Modon company, in strategic partnership with the Emirates Falconers' Club, at ADNEC Centre Abu Dhabi. The exhibition runs until 6 September.

The falcon, owned by Mark Moglich Falcon Farm in the United States, stands out for its rare pure white colouring and exceptional physical characteristics. Weighing 1,000 grams and measuring 16.5 inches in both length and width, the Qarmousha Pure Ultra White attracted considerable attention from leading falconers and bidders.

Humaid Matar Al Dhaheri, Group CEO of ADNEC Group, said: “The exceptional calibre of the falcons participating in these auctions reflects the global standing they have achieved through the Abu Dhabi International Hunting and Equestrian Exhibition. We remain committed to providing a platform that brings together the finest falcons and bloodlines from around the world. These auctions also play an important role in preserving breed quality and sustainability while reinforcing Abu Dhabi’s position as a leading international destination for falconry and its authentic traditions, supporting efforts to safeguard this treasured Emirati heritage for future generations.”

This year’s edition features 55 leading local and international falcon breeding and care farms, representing a 20% increase compared with last year. Among them are nine first-time participants, highlighting the growing stature of the auctions and their increasing appeal among breeders and falconers worldwide.

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Salam Shehady 

ADNEC@APCOWORLDWIDE.COM

Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera

 MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)

MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue

Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32

 

(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer.

MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the total amount of blood in the body. Maintaining controlled hematocrit levels below 45% is the primary treatment goal in PV.1

“For patients living with PV, uncontrolled hematocrit can have serious consequences, including an elevated risk of life-threatening thrombotic events," said Andrew T. Kuykendall, M.D., VERIFY lead investigator and Associate Member in the Department of Hematology at Moffitt Cancer Center. “Current treatments, such as phlebotomy, leave a significant gap for too many patients and can pose challenges to daily life and routines. The approval of MIMRYLO offers clinicians and patients a novel, first-in-class therapy that targets erythrocytosis, which drives excess red blood cell production in PV. The strength and consistency of the VERIFY data give me real confidence in MIMRYLO’s potential to advance how we treat PV in everyday practice and to maintain hematocrit control.”

Uncontrolled Hematocrit is a Challenge in the Treatment of PV

Affecting approximately 90,000 people in the U.S., PV is characterized by the overproduction of red blood cells (erythrocytosis), leading to elevated hematocrit which can increase blood viscosity, or thickness.2,3 This has the potential to result in life-threatening thrombotic events, including stroke, deep vein thrombosis and pulmonary embolism.4 Maintaining hematocrit levels consistently below 45% can prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, pruritus (itching), difficulty concentrating and night sweats.4 An estimated 78% of patients still experience uncontrolled hematocrit with current standard of care, including phlebotomy and cytoreductive therapies.5 Patients with PV experiencing uncontrolled hematocrit have a four times higher risk of cardiovascular death or major cardiovascular events.4

“People living with PV often experience complex and invisible symptoms, from extreme fatigue to the emotional strain of living with a chronic blood cancer,” said Kapila Viges, Chief Executive Officer, MPN Research Foundation. “At the same time, we know that every patient’s experience with PV is different, underscoring the need to continue to listen closely to the community to understand what matters most. There remains a need for treatments that better address these daily challenges. This meaningful approval reflects important progress and brings forward a new treatment option in a disease where patients have long needed innovation and more choices. We are encouraged by MIMRYLO’s potential to help patients meet their treatment goals.”

MIMRYLO is a First-In-Class Treatment Option for Adults with PV

The approval was supported by data from the global randomized Phase 3 VERIFY study (NCT05210790) that included 293 patients with PV, showing that MIMRYLO met all efficacy endpoints and demonstrated a favorable safety profile. In the study, patients receiving MIMRYLO plus current standard of care 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 fatigue as measured by PROMIS Fatigue Short Form 8a.

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.

“The approval of MIMRYLO underscores the strength of Takeda’s late-stage pipeline and our focus on developing genuinely differentiated therapies for patients who are urgently waiting for new options,” said Julie Kim, President and Chief Executive Officer, Takeda. “We are at an important inflection point as we prepare to deliver three new medicines, which have the potential to drive our future growth and are a reflection of our commitment to advancing innovation that doesn’t just add to the treatment landscape, but reshapes it. We are grateful to the patients, care partners, advocates and investigators who helped make this approval possible.”

The open-label extension of the VERIFY trial is ongoing and Takeda will share further findings at upcoming medical conferences. Takeda is working with regulators outside of the U.S. to potentially bring MIMRYLO to more patients worldwide.

This approval does not result in any changes to Takeda’s consolidated financial forecast for the fiscal year ending March 31, 2027 (FY2026).

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. 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 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.

*Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera

References

Barbui T, et al. Philadelphia chromosome-negative classical myeloproliferative neoplasms: revised management recommendations from European LeukemiaNet. Leukemia 2018; 32(5), 1057-1069.

Vachhani PJ. Estimated prevalence of polycythemia vera in the United States (2025-2030): SEER analysis with modeled reporting delay. J Clin Oncol. 2026;44(suppl 16):e18589.

Lu X, Chang R. Polycythemia Vera. [Updated 2023 Apr 24]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557660/

Marchioli R, et al. Cardiovascular events and intensity of treatment in polycythemia vera. N Engl J Med 2013;368:22-33.

VVerstovsek S, et al. Real-world treatments and thrombotic events in polycythemia vera patients in the USA. Ann Hematol 2023;102:571-581.

 

 

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Contacts

Investor Relations

Christopher O’Reilly

takeda.ir.contact@takeda.com

Japanese Media

Tsuyoshi Tada

toiawase_kouhou@takeda.co.jp

U.S. and International Media

Lauren Sherman

lauren.leedberg@takeda.com

TVS Motor Company Appoints Peyman Kargar as Director and Chief Executive Officer

 BENGALURU, India - Friday, 28. August 2026

Peyman Kargar appointed Director and Chief Executive Officer of TVS Motor Company, effective January 27, 2027

K. N. Radhakrishnan to continue as Director and Chief Executive Officer until then and subsequently will serve as Non-Executive Director up to the date of the ensuing AGM scheduled in July 2027

Appointment supports TVS Motor Company's next phase of growth and innovation

 

(BUSINESS WIRE) -- TVS Motor Company, part of TVS VENU and a leading global manufacturer of two and three-wheelers, today announced the appointment of Peyman Kargar as Director and Chief Executive Officer, effective January 27, 2027.

Peyman will succeed K. N. Radhakrishnan, who will continue in his role until then to ensure a seamless transition. Following the transition, Radhakrishnan will serve as Non-Executive Director up to the date of the ensuing AGM scheduled in July 2027. He has been a tremendous leader and played a pivotal role in the growth of TVS Motor Company.

The leadership transition comes as TVS Motor Company builds on strong business performance and continues to consolidate its position in India and expand its global presence. In FY2025-26, the company achieved a record performance, selling 5.9 million vehicles globally and delivering 30% revenue growth.

Peyman currently serves as President, International Business. He brings more than three decades of global automotive leadership experience across Europe, Asia, Africa and the Middle East, having held senior leadership positions with some of the automotive industry's most recognised global brands. His experience spans the full value chain, from product development and R&D to manufacturing, quality, sales and marketing, giving him significant insight into the factors that drive long-term success in the mobility industry. Under his leadership, International Business has become an increasingly important contributor to TVS Motor Company's global expansion. Today, the business contributes 29% of the company sales volume and is growing at 33%.

In his new role, he will lead the company as it focuses on further growing its business in India and globally through product innovation, premiumisation and expansion into developed markets.

Sudarshan Venu, Chairman, TVS Motor Company, said: "This appointment marks an important step for TVS Motor Company as we prepare for the future. Peyman is an accomplished global leader with deep industry experience, strategic vision and a strong understanding of customers and markets. As President, International Business, he has already made a meaningful contribution to our business, and I am confident he is the right person to lead TVS Motor Company and further strengthen our position among the world's leading mobility companies.

At TVS Motor Company, our values and culture are fundamental to who we are and how we operate. I am confident that Peyman will continue to build on these values and work towards our vision of transforming the quality of life of people across the world through mobility solutions that are exciting, responsible, sustainable and safe.

I would also like to thank K. N. Radhakrishnan for his outstanding contribution to TVS Motor Company and the wider TVS VENU group over many years. His leadership, passion, and commitment have helped shape the company into the strong organisation it is today. I am personally grateful for his valuable counsel, guidance and support."

Peyman Kargar, President, International Business, TVS Motor Company, said: “It is a privilege to be appointed as Chief Executive Officer of TVS Motor Company. Building on our momentum, we are entering into a new phase of growth, expanding our presence and further consolidating our position in India and global markets."

As we do so, the guiding principles of the TVS Way and its values will always be the North Star. I will be focused on realising the company’s vision and strengthening our technology leadership, AI capabilities, commitment to quality, and customer centricity. Together, these principles have helped create a culture where individuals and teams can thrive, innovate and deliver exceptional outcomes.

I look forward to working closely with our teams in India and around the world to strengthen our position in key markets, deliver for our customers and build on the foundations we have created."

K. N. Radhakrishnan, Director & CEO, TVS Motor Company, said: "It has been a privilege to serve TVS Motor Company as CEO and work alongside an exceptional team. I am grateful for the support, commitment and dedication of colleagues across the business, whose efforts have shaped the company that we are today.

I am confident Peyman will lead TVS Motor Company with distinction and wish him every success in the role and I look forward to supporting a smooth transition over the coming months."

About TVS Motor Company

TVS Motor Company (BSE: 532343 and NSE: TVSMOTOR), part of TVS VENU, is a reputed two and three-wheeler manufacturer globally, championing progress through sustainable mobility with four state-of-the-art manufacturing facilities located in India and Indonesia. Rooted in a 100-year legacy of trust, value and passion for customers, the company takes pride in making internationally accepted products of the highest quality through innovative and sustainable processes. TVS Motor is the only two-wheeler company to have won the prestigious Deming Prize. Its products lead in their respective categories in the J.D. Power IQS and APEAL surveys. The company has been ranked No. 1 in the J.D. Power Customer Service Satisfaction Survey for four consecutive years. Its group company, Norton Motorcycles, based in the United Kingdom, is one of the most emotive motorcycle brands in the world. TVS Motor Company endeavours to deliver the most superior customer experience across the 90+ countries in which it operates.

For more information, please visit www.tvsmotor.com.

 

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Contacts

For more information, please write to:

Andrew Roberts – Andrew.roberts@tvsmotor.com

Kanika Mehta – Kanika.Mehta@tvsmotor.com

 

JUST FOR LAUGHS REVEALS THE SEVEN WINNERS OF THE 2026 EDITION FOR THE MONTREAL AND QUEBEC FESTIVALS

 ELODIE POUX WINS THE WORLD COMEDY AWARD AND JESSÉ IS CROWNED REVELATION OF THE YEAR

You can find the full press release here

(BUSINESS WIRE)-- Being recognized by Just for Laughs can be a career-defining milestone, cementing a comedian’s place in the industry or giving their career a fresh boost. Following the conclusion of its Montreal and Quebec festivals, Just for Laughs announced the winners of its 2026 awards today – seven distinctions honoring the artists who made a particularly strong impression this year through the strength of their talent, the quality of their work, and the originality of their artistic approach.

For more than four decades, Just for Laughs has helped discover and showcase generations of comedians from around the world. Receiving one of its awards means becoming part of that legacy and earning recognition that can serve as a real springboard: a crowning achievement for some, a revelation for others, and sometimes the beginning of a whole new chapter.

“Through its awards, Just for Laughs pays tribute to artists, creators and trailblazers shaping the future of comedy. These honors celebrate the talent, boldness, and impact of those who help make comedy a universal language capable of bringing cultures closer together, building bridges between communities, and making the whole world laugh” , explains Sylvain Parent-Bédard, President and CEO of Just for Laughs.

“A Just for Laughs award is more than just a trophy: it’s a way of telling an artist that their work has made a lasting impression. Over the years, we’ve seen how recognition can help bring a new talent into the spotlight, affirm an approach, or give a career fresh momentum. This year, once again, we wanted to recognize the artists and creators who impressed us with the strength of their creative approach, their dedication, and the quality of their work. We’re extremely proud to help shine a spotlight on their work and, above all, to see them continue on their journey with this recognition under their belt” , emphasizes Josée Charland, Vice-President and Head of Programming & Talent at Just for Laughs.

Just for Laughs | HAHAHA.com

The original source-language text of this announcement is the official, authoritative version. Translations are provided as an accommodation only, and should be cross-referenced with the source-language text, which is the only version of the text intended to have legal effect.

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Contacts

Media Relations France: Morgane Dupont | DS Communication | Morgane.dupont@dscommunication.fr

Visa Expands Support for its Clients and the Industry as Organizations Navigate New AI Era of Cybersecurity

 SAN FRANCISCO - 

Latest Visa Vulnerability Agentic Harness release moves AI-powered cyber risk management from discovery to validated remediation

New services from Visa Consulting & Analytics help clients identify the vulnerabilities that matter most and act before bad actors do

 

(BUSINESS WIRE)--Visa (NYSE: V) today announced enhancements to its cybersecurity portfolio to help organizations identify and fix vulnerabilities more effectively. Unveiling the next evolution of the Visa Vulnerability Agentic Harness (VVAH), its open-source, model-agnostic framework, Visa is helping organizations significantly reduce the Mean Time to Adapt (MTTA), the time between discovery and resolution of attack paths, with some resolutions shrinking from weeks to hours.

And to help clients navigate this evolving threat landscape, Visa also announced the expansion of its Visa Consulting & Analytics (VCA) Cybersecurity Advisory Practice with new advisory services designed to help clients assess risk, prioritize remediation efforts and strengthen resilience in an evolving threat environment.

"AI is compressing the time between vulnerability discovery and exploitation, which means defenders need a faster, more reliable path to action," said Rajat Taneja, President, Technology, Visa. "By advancing VVAH and expanding our cybersecurity advisory capabilities, we're helping organizations move from insight to validated remediation while strengthening resilience in an increasingly AI-driven threat landscape."

Expanding VVAH

Originally released following Visa's participation in Anthropic's frontier AI cybersecurity initiative, Project Glasswing, VVAH demonstrated how AI can help security teams uncover vulnerabilities, assess exploitability and generate structured findings. The latest release extends that workflow beyond discovery into remediation and validation.

Key enhancements include:

Closed-loop remediation: Structured feedback helps teams refine fixes that fail validation without restarting the process.

Flexible model choice: Organizations can now deploy approved Anthropic models and OpenAI models, in addition to any other AI model through configuration rather than code changes.

Greater visibility: Optional real-time progress views provide additional transparency into long-running scans and remediation workflows.

The framework is designed to help organizations discover, triage, remediate and validate vulnerabilities within a single structured workflow.

New Cybersecurity Services

To help organizations operationalize those insights, Visa Consulting & Analytics is introducing three new cybersecurity advisory services informed by Visa's experience in AI-powered security:

AI Cyber Leadership Education – Executive workshops, trainings and Visa University certification courses led by Visa's AI and cybersecurity specialists, sharing lessons from Visa’s experience with frontier AI cybersecurity, helping leaders prepare for an increasingly AI-driven threat environment.

VVAH-Informed Cybersecurity Maturity Assessment – Helps organizations apply VVAH framework to identify and evaluate potential vulnerabilities, understand areas of risk and prioritize remediation efforts.

VVAH Cyber Risk Prioritization and Roadmap – Provides strategic guidance to help organizations evaluate findings, prioritize remediation efforts, and develop a long-term cyber risk management roadmap.

"Finding vulnerabilities is no longer the hardest part. Speed to remediation is the new battleground. When AI-enabled attackers move faster and probe at scale, companies need AI-powered defenses," said Carl Rutstein, global head of Visa Consulting & Analytics. "Our enhanced cybersecurity advisory services combine insights from implementing frontier AI models for cybersecurity, VVAH, and decades of payments expertise to help clients prioritize risk areas, act quickly and build sustainable cyber resilience."

Over the past year, Visa Consulting & Analytics' Cybersecurity Advisory Practice has supported clients across a range of cybersecurity advisory engagements intended to help clients evaluate cybersecurity maturity, assess areas of cyber risk, and identify potential priorities for strengthening risk management and operational resilience. One example is CAIXA Cartões, which worked with Visa to support its cybersecurity maturity assessment and help prioritize its risk management and operational resilience initiatives:

"At CAIXA, we understand that cybersecurity is a fundamental pillar for customer trust and business sustainability in an increasingly complex digital environment,” said Lessandro Thomaz, Executive Director at CAIXA Cartões. “Our partnership with Visa has helped broaden our strategic perspective on cybersecurity by providing a structured assessment of the maturity of our processes and supporting the prioritization of initiatives focused on risk management and operational resilience. Projects like this reinforce the importance of collaboration between financial institutions and strategic partners to anticipate challenges, strengthen capabilities and deliver increasingly secure and reliable solutions to our customers."

Growing Momentum Across the Security Community

Since its open-source release in June 2026, VVAH has been downloaded by tens of thousands of developers across the world, reflecting growing interest in practical AI-powered vulnerability management. Visa also recently joined industry initiatives to further support the development of safe, secure and open practices as frontier AI continues to evolve. As a part of NVIDIA’s Open Secure AI Alliance, Visa is contributing VVAH as a model-agnostic framework, and through IBM and Red Hat’s Project Lightwell initiative, Visa is collaborating with other organizations to help secure open-source software.

For more information, explore the Visa Vulnerability Agentic Harness on GitHub or learn more about Visa's Value-Added Services cybersecurity offerings here.

About Visa

Visa (NYSE: V) is a world leader in digital payments, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories. Our mission is to connect the world through the most innovative, convenient, reliable and secure payments network, enabling individuals, businesses and economies to thrive. We believe that economies that include everyone everywhere, uplift everyone everywhere and see access as foundational to the future of money movement. Learn more at Visa.com.

 

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Media Contact

Conor Febos

cfebos@visa.com