KYOTO, Japan, Apr 27, 2026 - (JCN Newswire) - OMRON Healthcare Co., Ltd., a global leader in clinically proven medical devices for home health monitoring and treatment, today announced its support for May Measurement Month 2026, the annual blood pressure screening and awareness campaign held in conjunction with World Hypertension Day (May 17). This year, OMRON Healthcare will support screening and awareness activities across participating countries through the donation of approximately 3,000 blood pressure monitors worldwide, including models capable of detecting the possibility of atrial fibrillation (AFib).

Hypertension is the leading risk factor for cardiovascular disease worldwide, contributing to more than 10 million deaths each year. However, while early detection and effective management can significantly reduce the risk of complications such as stroke and heart disease, in many regions awareness and treatment rates remain suboptimal. Launched in 2017, May Measurement Month aims to highlight the risks associated with hypertension and the importance of regular blood pressure monitoring. To date, the campaign has screened more than 7 million people globally, identifying over 1 million individuals with previously untreated hypertension.

OMRON Healthcare has supported May Measurement Month since the campaign’s inception, contributing to screening activities in around 120 countries and regions through the donation of approximately 33,000 blood pressure monitors to date. This year will see the company provide a further 3,000 devices, including models capable of screening for AFib, a common but underrecognized arrhythmia that often goes undiagnosed despite being a major risk factor for stroke and heart failure. The May–July campaign will raise awareness through screening events and educational activities worldwide, including blood pressure measurement sessions and guidance on dietary and other lifestyle changes for the management of hypertension.

Professor Neil R. Poulter, Chief Investigator and Chair of Trustees of May Measurement Month, commented, “Hypertension (high blood pressure) is the leading risk factor for cardiovascular diseases, including stroke, heart attacks, heart failure, and the potentially life-threatening arrhythmia atrial fibrillation. Furthermore, it is increasingly clear that regular home blood pressure monitoring improves hypertension management, which in turn reduces these major adverse cardiovascular events and the risk of atrial fibrillation. By donating blood pressure monitors that are also capable of detecting probable atrial fibrillation, this initiative can enhance early detection and treatment of hypertension and atrial fibrillation, ultimately helping to save more lives around the world from cardiovascular diseases.”

“Since the launch of our first home blood pressure monitor in 1973, we have worked alongside healthcare professionals to promote the importance of blood pressure monitoring and improve access to home measurement,” said Ayumu Okada, President and CEO of OMRON Healthcare Co., Ltd. “The goals of May Measurement Month align closely with our own Going for ZERO vision, which aims to eliminate cerebro-cardiovascular events worldwide, and we will continue to collaborate with May Measurement Month to improve global cardiovascular health outcomes through the further expansion of this important initiative.”

For more information about May Measurement Month, please visit:
https://maymeasure.org

About OMRON Healthcare

Committed to advancing health and empowering people worldwide to live life to the fullest, OMRON Healthcare is a global leader in the field of clinically proven, innovative medical equipment for home health monitoring and treatment. Aiming to realize its vision, “Going for ZERO, Preventive Care for the Health of Society,” the company develops products for cardiovascular condition management, respiratory care, and pain therapy. Building on this, it has introduced a new digital health ecosystem that bridges patients and healthcare professionals, helping to reduce cerebro-cardiovascular events, the worsening of respiratory diseases, and limitations caused by chronic pain.

With over 400 million units sold globally, OMRON provides the world's most recommended blood pressure monitors by healthcare professionals. Throughout its history, OMRON Healthcare has striven to improve lives and contribute to a better society by developing innovations that help people prevent, treat, and manage their medical conditions, providing products and services in over 130 countries.

For more information, please visit: 
Website: https://healthcare.omron.com/
LinkedIn: https://www.linkedin.com/company/omron-healthcare-co-ltd-/   

Media Enquiries

This press release is disseminated by Kyodo PR on behalf of OMRON Healthcare. For more information or for interview opportunities, please contact:
OMRON Healthcare Press Desk: omronhealthcare-pr@kyodo-pr.co.jp   

KYOTO, Japan, Apr 22, 2026 - (JCN Newswire) - OMRON Healthcare Co., Ltd., a global leader in clinically proven medical devices for home health monitoring and treatment, today announced the integration of its ECG-enabled upper arm blood pressure monitors with Tricog Health Pte. Ltd.’s clinically validated AI-powered cardiac triage service, Tricog CardioCheck (TCC). The service is scheduled for rollout at health centers across India from April 2026.

Tricog CardioCheck (TCC) enables ECG data recorded using OMRON Healthcare’s Complete™ blood pressure monitors with integrated ECG monitoring to be transmitted to the cloud and analyzed by Tricog’s AI algorithms. Within approximately 10 seconds, the system provides a three-level risk assessment, supporting patient triage and timely clinical evaluation.

Results are displayed via a dedicated smartphone application designed for healthcare professionals, allowing front-line care providers to review patient risk levels in real time and quickly determine the need for further examination, even where a cardiology specialist is not immediately available.

Cardiovascular disease represents a growing public health challenge in India, with the number of patients projected to increase from approximately 110 million today to 230 million by 2050. At the same time, access to specialized care remains limited, with far fewer cardiology specialists per capita than Japan or the United States and limited access to facilities equipped for advanced cardiac testing.

While early identification can be crucial to the effective management of cardiovascular conditions such as heart failure and heart attacks, helping to reduce the risk of serious complications including strokes, many cases go undetected until overt symptoms begin to develop.

By integrating ECG measurement into routine blood pressure monitoring at clinics, Tricog CardioCheck (TCC) supports the identification of patients whose underlying conditions may otherwise go undiagnosed. Furthermore, the system enables cardiovascular screening to be incorporated into existing workflows without significantly increasing operational burden, facilitating earlier detection and more timely referral for further evaluation.

Since its initial investment in Tricog in fiscal year 2023, OMRON Healthcare has continued to strengthen its partnership with the company in order to address key healthcare challenges in India. Through ongoing collaboration, both companies aim to expand access to innovative diagnostic solutions and contribute to improving cardiovascular health outcomes across the country.

About OMRON Healthcare

Committed to advancing health and empowering people worldwide to live life to the fullest, OMRON Healthcare is a global leader in the field of clinically proven, innovative medical equipment for home health monitoring and treatment. Aiming to realize its vision, “Going for ZERO, Preventive Care for the Health of Society,” the company develops products for cardiovascular condition management, respiratory care, and pain therapy. Building on this, it has introduced a new digital health ecosystem that bridges patients and healthcare professionals, helping to reduce cerebro-cardiovascular events, the worsening of respiratory diseases, and limitations caused by chronic pain.

With over 400 million units sold globally, OMRON provides the world's most recommended blood pressure monitors by healthcare professionals. Throughout its history, OMRON Healthcare has striven to improve lives and contribute to a better society by developing innovations that help people prevent, treat, and manage their medical conditions, providing products and services in over 130 countries.

For more information, please visit: 
Website: https://healthcare.omron.com/
LinkedIn: https://www.linkedin.com/company/omron-healthcare-co-ltd-/

Media enquiries

This press release is disseminated by Kyodo PR on behalf of OMRON Healthcare. For more information or for interview opportunities, please contact:
OMRON Healthcare Press Desk: omronhealthcare-pr@kyodo-pr.co.jp 

Strasbourg, France & Schiphol, Netherlands, Apr 3, 2026 - (JCN Newswire) - Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Bio B.V. ("NEC"), a wholly owned subsidiary of NEC Corporation (TSE: 6701), a leader in IT, network and AI technologies, announce the signing of a license agreement to advance the clinical development of TG4050, an individualized neoantigen therapeutic vaccine (INTV) in the adjuvant treatment of resected HPV-negative head and neck cancer.

TG4050 is an individualized immunotherapy based on an MVA viral vector incorporating neoantigens selected using NEC’s AI-enabled prediction platform. It is currently being evaluated in patients with head and neck cancer with the aim of preventing relapse and extend disease-free survival following surgery and adjuvant therapy. TG4050 is designed to stimulate and educate the immune system against a patient’s cancer using tumor-specific genetic mutations (neoantigens) targeting each patient’s unique tumor. These neoantigens are identified and selected using NEC’s proprietary platform, which applies advanced machine learning to select immunogenic mutations that are most likely to induce a strong immune response.

Under the terms of the license agreement, Transgene secures access to NEC’s AI-based neoantigen prediction platform for further development of TG4050 in the adjuvant treatment of resected HPV-negative head and neck cancer while conferring rights to enable Transgene’s further clinical development and to support commercialization and potential partnering of the program. NEC retains full ownership and operational control of its AI platform and will support Transgene to conduct further clinical activity.

NEC will receive a technology access fee of €2.5 million in Transgene shares following the signing (see below) and an additional €2.5 million in cash to be paid out in a series of tranches through early 2028. Additionally, a further payment will be milestone-based and a portion of such payment will be made in Transgene’ shares. NEC is also eligible to receive undisclosed additional consideration including development milestone payments, as well as a double-digit share of profits or licensing revenues.

"Building on the results of our long-standing collaboration and with the license to use NEC’s prediction platform, we are now in a strong position to pursue further development of TG4050, which will be informed by data from our ongoing Phase 2 trial. We are also pleased to welcome NEC as a shareholder of Transgene and appreciate their confidence as we work together to advance a treatment that has the potential to improve the outcomes for patients at risk of relapse in head and neck cancer," said Dr. Alessandro Riva, Chairman and CEO of Transgene.

Akira Kitamura, GM, AI Drug Development Division of NEC Corporation and CEO of NEC Bio, added, "This agreement is an important milestone in our partnership with Transgene and reflects NEC’s long-term commitment to the development of TG4050. This collaboration is a clear example of how NEC can bring differentiated AI capabilities to biopharma. The clinical data generated to date is encouraging and support the potential of TG4050 as a promising approach to reducing relapse risk in patients with head and neck cancer. We look forward to deepening our collaboration with Transgene and to realizing the full clinical and strategic potential of this partnership."

Capital increase

As indicated above, a €2.5 million portion of the access fee to be paid to NEC will be paid in Transgene shares. Transgene will thus issue 3,345,824 new shares to NEC Bio B.V. at a price of €0.7472 per share. This price corresponds to the volume-weighted average (VWAP) of the last five (5) closing prices of the Transgene shares on the regulated market of Euronext in Paris prior to signing. The new shares will represent 1.22% of the share capital of Transgene post issuance (and 0.98% of its voting rights)1.

The capital increase is carried out on the basis of the 22nd resolution of the Combined General Meeting of May 15, 2025. The new shares will be admitted to trading on the regulated market of Euronext in Paris as soon as they are issued and will be immediately assimilated to the existing Transgene shares (ISIN code FR0005175080).

The capital increase is expected to be completed by the end of April 2026.

(1) Based on today’s share capital and voting rights.Share

About TG4050

TG4050 is an individualized immunotherapy being developed in the treatment of resected HPV-negative head and neck cancer that is based on Transgene’s myvac® technology and powered by NEC’s longstanding artificial intelligence (AI) and machine learning (ML) expertise. This virus-based individualized neoantigen therapeutic vaccine (INTV) encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to prioritize and select the sequences that are predicted to be the most immunogenic sequences.

TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient.

About Transgene

Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. The Company’s clinical-stage programs consist of a portfolio of viral vector-based immunotherapeutics. TG4050, the first individualized therapeutic vaccine based on the myvac® platform is the Company’s lead asset, with demonstrated proof of principle in patients in the adjuvant treatment of head and neck cancers. The Company has other viral vector-based assets, including BT-001, an oncolytic virus based on the Invir.IO® viral backbone, which is in clinical development. The Company also conducts innovative discovery and preclinical work, aimed at developing novel immunotherapies.With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC.Additional information about Transgene is available at: www.transgene.com
Follow us on social media: X: @TransgeneSA — LinkedIn: @Transgene — Bluesky: @Transgene

About NEC Corporation

The NEC Group leverages technology to create social value and promote a more sustainable world where everyone has the chance to reach their full potential. NEC Corporation was established in 1899. Today, the NEC Group’s approximately 110,000 employees utilize world-leading AI, security, and communications technologies to solve the most pressing needs of customers and society. For more information, please visit https://www.nec.com, follow us on Instagram, Facebook, and LinkedIn.

About NEC Bio

NEC Bio is the biotechnology arm of NEC Corporation, headquartered in the Netherlands, and focused on leveraging state of the art AI technologies to address world's most pressing healthcare challenges. Leveraging cutting-edge science, data, and innovation, NEC Bio is dedicated to developing personalized therapies designed to transform patient outcomes and improve quality of life globally. With a growing international footprint, NEC Bio includes subsidiaries such as NEC OncoImmunity in Oslo, Norway, and NEC Bio Therapeutics in Mannheim, Germany—each contributing specialized expertise across immunotherapy, precision medicine, and translational research. Together, these entities form a collaborative ecosystem committed to accelerating innovation from discovery to patient impact.To learn more, visit www.nec-bio.com and follow us on LinkedIn for the latest updates.

Disclaimer
This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results, regulatory authorities’ agreement with development phases, and development. The Company’s ability to commercialize its products depends on but is not limited to the following factors: positive pre-clinical data may not be predictive of human clinical results, the success of clinical studies, the ability to obtain financing and/or partnerships for product manufacturing, development and commercialization, and marketing approval by government regulatory authorities. For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Universal Registration Document, available on the AMF website (http://www.amf-france.org) or on Transgene’s website (www.transgene.com). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

HONG KONG, Apr 2, 2026 - (ACN Newswire) - Across the landscape of global biotech companies, the appointment of a senior executive often serves as a "barometer"—offering insights into a company's pipeline potential and reflecting how industry veterans gauge the sector’s future.

A clear signal of the company’s growth arrived in February 2026, when HighTide Therapeutics (2511.HK) announced a high-profile executive appointment: Dr. Filip Surmont joined the company as Chief Medical Officer (CMO).

For professionals in the cardiovascular, renal, and metabolic fields, this is a name that carries real weight. Over a career spanning three decades, Dr. Surmont has held senior medical leadership roles at multinational giants including Wyeth, Pfizer, and AstraZeneca. Among his most notable contributions was his role in the global strategic development of the SGLT-2 inhibitor dapagliflozin — a landmark effort that required close collaboration across functions and geographies within a large multinational organization. As part of a talented cross-functional team, he helped shape the strategy that positioned dapagliflozin as a global metabolic blockbuster, ultimately reaching $8.405 billion USD in sales in 2025.

Notably, just a few months earlier, HighTide Therapeutics' core product, HTD1801, had outperformed dapagliflozin across multiple key cardiovascular, renal, and metabolic endpoints in a head-to-head Phase III clinical trial for type 2 diabetes mellitus (T2DM).

For Dr. Surmont, transitioning from managing a reigning "blockbuster" to joining a “challenger” Chinese biotech was far from coincidental. What drew him out of his comfort zone was not just HTD1801's strong glucose-lowering performance, but also the breakthrough potential this new molecular entity (NME) has shown in cardiovascular, kidney and metabolic (CKM) disease in general, and chronic kidney disease (CKD) more specifically — driven by a fundamentally differentiated pathophysiological mechanisms.

I. Challenging Clinical Complacency in CKD: The Quest for True Reversal

Within the medical community, chronic kidney disease (CKD) has long been a source of frustration. Once the kidney function begins to decline, it typically deteriorates progressively and irreversibly over time, leaving most patients facing dialysis or kidney transplantation as an eventual outcome.

"There has long been a degree of complacency in CKD treatment among physicians, patients, and even caregivers," Dr. Surmont noted pointedly. "A mindset has taken hold that the progressive decline in renal function with age is inevitable. I’ve been striving to change this mindset throughout my career, both during my time at multinational pharmaceutical companies and now."

Current standard treatments — including ACE inhibitors/ARBs and the widely used SGLT-2 inhibitors — have demonstrated efficacy in slowing disease progression, yet fall short of halting or reversing the underlying pathology. They can significantly reduce the rate of decline in the estimated glomerular filtration rate (eGFR), buying patients valuable time, but fail to alter the terminal trajectory towards kidney failure.

Further complicating the clinical picture is the multi-factorial nature of CKD. Taking diabetic kidney disease (DKD) caused by T2DM as an example, besides pathophysiological factors driven by metabolic dysfunction, it is complicated by interconnected and highly complex factors such as hemodynamic perturbances, chronic inflammation, fibrosis, and other non-diabetic factors that fuel each other to worsen disease prognosis.

Existing standard-of-care drugs often address only one dimension of the disease by regulating hemodynamics or a single metabolic pathway, making it difficult to comprehensively address the inflammatory damage in the renal microenvironment.

II. Inside the Mechanism: Remodeling Renal Architecture via a Dual Metabolic and Anti-inflammatory Pathway

The emergence of HTD1801 provides a new key to breaking this deadlock.

As an oral anti-inflammatory and metabolic modulator (AIMM) independently developed by HighTide Therapeutics, HTD1801 demonstrates a unique therapeutic potential at the microscopic level as compared to traditional drugs. Rather than relying on a single mechanism, it takes a "two-pronged" approach by activating AMPK (adenosine monophosphate-activated protein kinase) and inhibiting the NLRP3 inflammasome.

Dr. Surmont has full confidence in the scientific logic underpinning this mechanism: "This drug acts simultaneously on two critical levels: beyond blood sugar, it improves overall metabolic efficiency at its source; at the same time, it directly suppresses the underlying chronic inflammation that drives organ damage."

Taking a deep dive into its mechanism of action, HTD1801's dual mechanism precisely targets multiple microstructures within the kidney. "This is reflected across different renal compartments," Dr. Surmont explained. "From the filtering glomeruli and the structural interstitium to the reabsorptive tubules, and even podocytes—the vital gatekeepers of the filtration barrier, the dual action of AMPK activation and NLRP3 inhibition has demonstrated stronger-than-expected protective benefits."

This mechanistic rationale, spanning from metabolic regulation to organ-level protection, has ultimately been validated by clinical data.

At the 2025 American Society of Nephrology (ASN) Annual Meeting, HighTide Therapeutics presented as a late breaker Phase III clinical study data in T2DM patients with mild renal impairment. The results captured the industry's attention: compared with the placebo group, the HTD1801 group demonstrated a significant and sustainable difference in annualized eGFR slope of +9.81 ml/min/1.73 m²/year.

In the eyes of nephrologists, a "positive slope" on the eGFR curve is a strong and unique signal, suggesting the possibility of early structural recovery.

"What we need to do next is confirm that this eGFR repair effect observed in DKD also holds true for CKD patients not driven by diabetes," Dr. Surmont revealed, indicating that relevant clinical studies are already underway, with more detailed data expected to validate this cross-etiology therapeutic potential.

III. From "Rescue" to "Prevention": Advancing a Holistic Cardiorenal Metabolic (CKM) Mindset

Dr. Surmont brings to HighTide Therapeutics more than just clinical expertise; he brings a “game-changing” mentality that transcends a single-drug perspective.

Another career-defining milestone for Dr. Surmont was his leadership role in helping reshape global asthma treatment guidelines. Historically, asthma management relied on short-acting bronchodilators for "rescue" only upon exacerbation of symptoms and shortness of breath. Dr. Surmont proposed and validated the "Anti-Inflammatory Reliever (AIR)" strategy a modern asthma management strategy that uses a combination inhaled corticosteroids and a bronchodilator as a reliever — treating both the acute bronchospasm and the underlying airway inflammation with every dose, in contrast to traditional short acting dilator-only relief.  This shift ultimately benefited approximately 120 million patients worldwide and reshaped treatment paradigms.

Now, facing CKD, he sees the same opportunity for a paradigm-shifting breakthrough.

Given HTD1801's strong potential to repair mild renal impairment, future clinical guidelines could reasonably recommend initiating treatments early, when eGFR is still at a relatively high level. By establishing a positive trajectory for renal function recovery early in the disease, there is hope that most patients can completely avoid the looming threat of dialysis.

From a health-economics perspective, this would reallocate healthcare spending: shifting funds away from costly late-stage interventions (such as dialysis and heart failure rescue) towards highly cost-effective early treatment, thereby generating substantial healthcare cost savings for society and reducing patients’ financial burden for late-stage interventions.

Dr. Surmont also strongly advocates for a holistic management approach to "Cardiovascular-Kidney-Metabolic (CKM)" health. As multifunctional drugs like HTD1801 continue to evolve, he believes physicians will move beyond the single-dimensional therapeutic mindset.

"My ideal scenario is that all physicians managing cardiovascular, metabolic, renal, hepatic, or even obesity issues would evaluate the patient with a holistic mindset," he says, pointing to the current siloed nature in clinical practice. " As an example eGFR monitoring is not always part of routine cardiological assessment, yet at the mechanistic level, cardiac and renal dysfunction are manifestations of the same underlying disease process — making an integrated view essential"

He cited a successful experiment he led while promoting dapagliflozin in China: requiring cardiologists at partner hospitals to measure patients' eGFR during their consultations. By merely adding this simple cross-disciplinary action, the number of patients on guideline directed medical treatment tripled within six months.

IV. A Buyer's Lens: The Booming BD Activity in CKD and HighTide Therapeutics’ Confidence in Value Creation

As a core member of the company's leadership team, Dr. Surmont also frequently examines HighTide Therapeutics' position through the lens of capital market and industry dynamics.

Over the past two years, the global biopharmaceutical market has seen a surge in business development (BD) activity in the CKD field. In 2025, Roche announced a major collaboration with Zealand Pharma valued at up to $5.3 billion; multinational giants like Novartis, Boehringer Ingelheim, and Novo Nordisk have also been making significant investments to secure premium assets in the metabolic and renal disease space.

Dr. Surmont, drawing on his extensive multinational experience, has a clear read on this "land grab" phenomenon: "The core driver is the massive profit potential and rapid growth in this field. Five years ago, the therapeutic arsenal here was relatively limited. Now, with breakthrough blockbusters like GLP-1RAs and SGLT-2i’s, the kidney disease landscape has been reshaped, yet there remains a residual risk is 60–80% of the original event burden.

He further elaborated: "Even when patients are treated with four pillars of therapy (ACEi/ARBs, SGLT-2i’s, GLP-1RAs, MRAs), the complex underlying inflammatory mechanisms remain largely unaddressed, still leaving a significant gap in our ability to fully protect the kidney. This creates substantial pricing potential and broad combination therapy prospects for drugs with fundamentally new mechanisms like HTD1801."

"Looking back at the history of SGLT-2 inhibitors, it took over a decade from approval to reaching 20%-25% guideline-directed clinical uptake. The slow progress was partly due to a lack of strong medical education and advocacy, and partly because of physicians and patients’ tendency to yield to the disease's natural trajectory."

Now, having taken the helm as CMO of HighTide Therapeutics, Dr. Filip Surmont is poised to challenge the status quo and break this complacency with solid clinical data and a new medical narrative. For this drug—born from Chinese innovation with a global ambition—the voyage in the CKM field has only just begun.

TOKYO, Mar 27, 2026 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and MSD K.K. (Headquarters: Tokyo, Representative Director: Prashant Nikam, “MSD”), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, announced today that an application for LENVIMA® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, has been submitted in Japan for the additional dosage and administration in combination with WELIREG® (belzutifan), the first-in-class oral hypoxiainducible factor-2 alpha (HIF-2α) inhibitor from MSD, for the treatment of unresectable or metastatic renal cell carcinoma that has progressed after chemotherapy.

This application is based on the results of the Phase 3 LITESPARK-011 trial evaluating the dual regimen of LENVIMA plus WELIREG for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-programmed death receptor-1 (PD-1)/ programmed death-ligand 1 (PD-L1) therapy. The data from this trial were presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium in February 2026. At a pre-specified interim analysis with a median follow-up of 29.0 months (range, 19.3-49.2), the LENVIMA plus WELIREG combination therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the primary endpoints, reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. The safety profile of this combination was consistent with those reported for each agent administered as monotherapy, and no new safety signals were identified.

In 2022, approximately 435,000 people worldwide were newly diagnosed with kidney cancer, and about 156,000 people died from the disease. 1 In Japan, it is estimated that roughly 21,000 people were newly diagnosed and about 7,000 died in 2022.2 RCC accounts for approximately 85% of kidney cancers3, and the five-year survival rates for patients with stage III and IV RCC have been reported as 63%–78% and 27%–28%4, respectively, indicating that the disease still has a high unmet medical needs.

LENVIMA is approved in combination with KEYTRUDA ® (pembrolizumab) in Japan for the first-line treatment of unresectable or metastatic RCC. WELIREG is approved in Japan for the treatment of unresectable or metastatic RCC that has progressed following cancer chemotherapy. Additionally, supplemental New Drug Applications (sNDA) for the LENVIMA and WELIREG combination therapy for the treatment of adult patients with advanced RCC with a clear cell component following a PD-1 or PDL1 inhibitor has been accepted by the U.S. Food and Drug Administration (FDA), with a PDUFA (Prescription Drug User Fee Act) target action date set for October 4, 2026.

Eisai and MSD have been collaborating through the provision of information on LENVIMA in Japan since October 2018, and will work together to expedite the maximization of contribution to patients with cancer.

About LENVIMA (lenvatinib)

LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1- 4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. LENVIMA has been approved for the indications below.

Thyroid cancer
- Indication as monotherapy
(Approved mainly in Japan, the United States, Europe, China and Asia)
Japan: Unresectable thyroid cancer
The United States: The treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer (DTC)
Europe: The treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI)

Hepatocellular carcinoma
- Indication as monotherapy
(Approved mainly in Japan, the United States, Europe, China and Asia)
Japan: Unresectable hepatocellular carcinoma
The United States: The first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)
Europe: The treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy
- Indication in combination with KEYTRUDA (generic name: pembrolizumab) and transarterial chemoembolization (Approved in China)

Thymic carcinoma
- Indication as monotherapy (Approved in Japan)
Japan: Unresectable thymic carcinoma

Renal cell carcinoma (In Europe other than the United Kingdom, the agent was launched under the brand name Kisplyx®)
- Indication in combination with everolimus
(Approved mainly in the United States, Europe and Asia) The United States: The treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy
Europe: The treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy
- Indication in combination with KEYTRUDA
(Approved mainly in Japan, the United States, Europe and Asia)
Japan: Radically unresectable or metastatic renal cell carcinoma
The United States: The first-line treatment of adult patients with advanced renal cell carcinoma
Europe: The first-line treatment of adult patients with advanced renal cell carcinoma

Endometrial carcinoma
- Indication in combination with KEYTRUDA
(Approved mainly in Japan, the United States, Europe and Asia)
Japan: Unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy
The United States: The treatment of patients with advanced endometrial carcinoma that is pMMR or not microsatellite instability-high (MSI-H), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
Europe: The treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery.

About WELIREG (belzutifan)

WELIREG, Merck & Co., Inc., Rahway, NJ, USA’s, known as MSD outside of the United States and Canada, first-in-class hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, is an orally administered small-molecule designed to reduce transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth. By inhibiting HIF-2α signaling, WELIREG aims to disrupt key pathways certain tumors may use to adapt to low-oxygen conditions, including those that help promote abnormal blood vessel formation and support tumor survival. WELIREG has demonstrated antitumor activity in certain von Hippel-Lindau (VHL) diseaseassociated tumors, renal cell carcinoma and in pheochromocytoma or paraganglioma. As part of a broader clinical program, Merck & Co., Inc., Rahway, NJ, USA continues to research WELIREG monotherapy and combination approaches for people with genitourinary, breast and gynecologic cancers across a range of treatment settings to further define where HIF-2α inhibition may provide clinical benefit and to better understand which patients are most likely to respond. WELIREG has been approved in Japan for the treatment of certain von Hippel–Lindau (VHL) disease–associated tumors, as well as for unresectable or metastatic renal cell carcinoma that has progressed after chemotherapy.

LITESPARK-011 Results

Data from LITESPARK-011 (ClinicalTrials.gov, NCT04586231) were presented at the ASCO GU Symposium held in February 2026. LITESPARK-011 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04586231) evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced clear cell RCC that has progressed on or after anti-PD-1/L1 therapy. The dual primary endpoints are progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR), and overall survival (OS). Secondary endpoints include objective response rate (ORR) per RECIST v1.1 as assessed by BICR, duration of response (DOR) per RECIST v1.1 as assessed by BICR, and safety. The trial enrolled 747 patients who were randomized to receive WELIREG (120 mg orally once daily) plus LENVIMA (20 mg orally once daily) or cabozantinib (60 mg orally once daily).

At a pre-specified second interim analysis with a median follow-up of 29.0 months (range, 19.3- 49.2), WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS, reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. For WELIREG plus LENVIMA, the median PFS was 14.8 months (95% CI, 11.2-16.6) versus 10.7 months (95% CI, 9.2-11.1) for cabozantinib. A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA (HR=0.85 [95% CI, 0.68-1.05]; p=0.06075). The median OS was 34.9 months (95% CI, 27.5-NR) for WELIREG plus LENVIMA versus 27.6 months (95% CI, 24.0-31.4) for cabozantinib. The trial is continuing, and OS will be evaluated at a subsequent analysis per the clinical trial protocol. Regarding secondary endpoints, at the first interim analysis with a median follow-up of 19.6 months (range, 9.9-39.8), WELIREG plus LENVIMA met ORR, demonstrating a statistically significant improvement compared to cabozantinib. A confirmed ORR of 52.6% (95% CI, 47.3-57.7) was observed for WELIREG plus LENVIMA versus 39.6% (95% CI, 34.6-44.8) for cabozantinib. At the second interim analysis with a median follow-up of 29.0 months, the median DOR was 23.0 months (95% CI, 2.0-44.3+) for WELIREG plus LENVIMA versus 12.3 months (95% CI, 1.8+-35.9+) for cabozantinib. WELIREG plus LENVIMA was administered to 370 patients and cabozantinib was administered to 371 patients. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 71.6% of patients receiving WELIREG plus LENVIMA versus 65.8% of patients receiving cabozantinib. Adverse events led to treatment discontinuation in 11.1% of patients receiving WELIREG plus LENVIMA and in 11.3% of patients receiving cabozantinib, respectively. Serious adverse events were observed in 51.6% of patients receiving WELIREG plus LENVIMA versus 43.9% of patients receiving cabozantinib, and AEs led to death in 5.4% of patients (two were treatment-related: thrombotic microangiopathy [n=1] and pneumonitis [n=1]) versus 3.2% (one was treatment-related: hemoptysis [n=1]) of patients, respectively.

About the Eisai and Merck & Co., Inc., Rahway, NJ, USA Strategic Collaboration

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, KEYTRUDA, and HIF-2α inhibitor, WELIREG.

Eisai’s focus on cancer

Eisai acknowledges “Oncology” as one of its key strategic areas, and will continue to focus on the discovery and development of anti-cancer drugs within drug discovery domains including “microenvironment”, “protein integrity and homeostasis”, and “cell lineage and cell differentiation” under the Deep Human Biology Learning (DHBL) drug discovery and development organization. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.

6. About Eisai

Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners. For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia, and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X (U.S. and global), LinkedIn (for U.S. and EMEA) and Facebook (global).

Merck & Co., Inc., Rahway, NJ, USA’s Focus on Cancer

Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology

About MSD

At MSD (the name by which Merck & Co., Inc., Rahway, NJ, USA, is known outside of the United States and Canada), we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.co.jp and connect with us on Facebook, Twitter, and YouTube.

1. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, et al. (2024) Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf, accessed 27 Mar 2026.
2. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, et al. (2024) Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer, Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/392-japan-fact-sheet.pdf, accessed 27 Mar 2026.
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. 2025; 2026 Version 1. 
4. Rose TL and Kim WY. Renal cell carcinoma: a review. JAMA. 2024 Sep 24;332(12):1001– 10.

Media Inquiries

Eisai Co., Ltd.
Public Relations Department
TEL: +81 (0)3-3817-5120

MSD K.K.
Communications Division
Tatsuro Murase
TEL: +81 (0)70-8700-0112

TOKYO and NEW YORK, NY., Mar 27, 2026 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., “Nuvation Bio”), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The filing will follow a standard review timeline.

Taletrectinib (marketed as IBTROZI® in the U.S. and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC.1 In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Following this filing to the EMA, additional filings are planned for the U.K., Canada and other regions included in Eisai’s licensed territories.

Across Europe, nearly 400,000 people are diagnosed with lung cancer each year with NSCLC accounting for 80% of cases.2,3 It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.4,5

“The validation of the MAA is a significant moment for patients in Europe with ROS1+ NSCLC,” said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. “With its efficacy and safety profile, we believe taletrectinib has the potential to become a standard of care therapy for the thousands of patients living with this aggressive disease in Europe. We look forward to working closely with the EMA during the review process with the goal of making this treatment available to appropriate patients who urgently need targeted options.”

The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally.6,7 Results from a pooled analysis of the TRUST clinical program were published in the Journal of Clinical Oncology in April 20258, and Nuvation Bio anticipates near-term disclosure of updated data reflecting even longer patient follow-up, further building on the depth and durability of responses observed to date. Additionally, given the comprehensive nature of the taletrectinib clinical dataset and based on favorable feedback received at a pre-submission meeting with the CHMP Rapporteur and Co-Rapporteur, the accepted MAA will be considered to support full approval.

“Having seen the meaningful impact taletrectinib has already made for patients with ROS1+ NSCLC in the U.S., China and Japan, we are thrilled to partner with Eisai and have an accepted MAA for review in Europe,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “This accepted filing represents an important milestone in our global development strategy and brings us one step closer to delivering this highly selective, next-generation oral therapy to more patients who need it in Europe and around the world.”

In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON®.

* Eisai’s licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and India

About ROS1+ NSCLC

Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer.9 It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.4,5 About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain.10 The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.10,11

About Taletrectinib

Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com. 1

About the TRUST Clinical Program

The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.6,7

About Eisai Co., Ltd.

Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe.

About Nuvation Bio

Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients’ lives. Our diverse pipeline includes taletrectinib (IBTROZI®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program.

Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc).

U.S. Indication

IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ nonsmall cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI® (taletrectinib)1

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS

Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

• Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
• Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS
• Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
• Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
• Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
• Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
• Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full U.S. Prescribing Information.

(1) Nuvation Bio Inc. IBTROZI (taletrectinib) US prescribing information. Available at: https://ibtrozipi.com/IBTROZI_taletrectinib-prescribing-information.pdf. Last accessed: March 2026
(2) Wood R, Taylor-Stokes G. Cost burden associated with advanced non-small cell lung cancer in Europe and influence of disease stage. Available here. Last accessed: March 2026
(3) European Lung Foundation. Lung cancer. Available here. Last accessed: March 2026
(4) Patil T, Smith DE, Bunn PA Jr, et al. The incidence of brain metastases in stage IV ROS1-rearranged non-small cell lung cancer and rate of central nervous system progression on crizotinib. J Thorac Oncol. 2018;13(11):1717-1726. doi:10.1016/j.jtho.2018.07.012.
(5) Drilon A, Camidge DR, Lin JJ, et al. Repotrectinib in ROS1 fusion-positive non-small-cell lung cancer. N Engl J Med. 2024;390(2):118-131. doi:10.1056/NEJMoa2302299. 
(6) ClinicalTrials.gov. A Study of AB-106 in Advanced NSCLC With ROS1 Fusion (NCT04395677). Available at: https://clinicaltrials.gov/study/NCT04395677 . Last accessed: March 2026
(7) ClinicalTrials.gov. A single-arm Phase 2 study of taletrectinib in advanced ROS1-positive NSCLC (NCT04919811). Available at: https://clinicaltrials.gov/study/NCT04919811 . Last accessed: March 2026
(8) Pérol M, A., et al. Taletrectinib in ROS1-positive non-small cell lung cancer: TRUST. Journal of Clinical Oncology, 43(16), 1920–1929. https://doi.org/10.1200/JCO-25-00275
(9) Global Data. Diagnosed incident cases of non-small cell lung cancer across 8MM to reach 1.46 million in 2032, forecasts GlobalData. Available here. Last accessed: March 2026
(10) Patil T, Smith DE, Bunn PA Jr, et al. The incidence of brain metastases in stage IV ROS1-rearranged non-small cell lung cancer and rate of central nervous system progression on crizotinib. J Thorac Oncol. 2018;13(11):1717-1726. doi:10.1016/j.jtho.2018.07.012.
(11) Drilon A, Camidge DR, Lin JJ, et al. Repotrectinib in ROS1 fusion-positive non-small-cell lung cancer. N Engl J Med. 2024;390(2):118-131.

MEDIA CONTACTS

Eisai Co., Ltd.
Public Relations Department
TEL: +81 (0)3-3817-5120

Nuvation Bio Inc.
Kaitlyn Nealy
media@nuvationbio.com

INVESTOR CONTACTS

Eisai Co., Ltd.
Investor Relations Department
TEL: +81 (0) 3-3817-5122

Nuvation Bio Inc.
JR DeVita
ir@nuvationbio.com

Forward-Looking Statements of Nuvation Bio Inc.

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding taletrectinib’s therapeutic potential and the urgent need for new therapeutic options for patients with advanced ROS1+ NSCLC in Europe, our expectations that the MAA filing for taletrectinib will follow a standard review with a decision in 1H 2027 and be considered for full approval, plans for additional filings for the U.K., Canada and other regions included in Eisai’s licensed territories, and expectations for near-term disclosure of updated data. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and commercialization, and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-K filed with the SEC on March 2, 2026 under the heading “Risk Factors,” and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

TOKYO, Mar 26, 2026 - (JCN Newswire) - NEC Corporation (NEC; TSE: 6701) announced that its FonesVisuas Test, an innovative blood test that predicts disease risk, is being offered by Royal Healthcare (*1), a Singapore-based medical institution and group company of Sojitz Corporation that combines the latest medical expertise with the art of hospitality.

Entrance of the Specialist Medical Centre                       Interior of the Specialist Medical Centre

According to the World Health Organization (WHO), the global rise in lifestyle-related diseases and dementia underscores the urgency for advanced predictive diagnostics (*2). Concurrently, the Organisation for Economic Co-operation and Development (OECD) iLibrary data has identified cancer and cardiovascular diseases as leading causes of mortality worldwide (*3), amplifying the urgency for proactive health management solutions.

Royal Healthcare is based in Singapore's medical hub, Novena, providing personalized, high-quality health screening services alongside customized medical experiences that prioritize efficiency and convenience for both local and international patients.

The addition of the FonesVisuas Test represents a significant advancement by analyzing proteins that reflect dynamic physiological changes. From just a small blood sample, the test can predict risks of developing conditions such as dementia, heart attack, lung cancer, chronic kidney disease, and prostate cancer over the next several years.

Royal Healthcare combines its services with conventional health checkups to guide individuals who are not yet ill but also not in optimal health toward lifestyle improvements. This approach aims to prevent future illness and enhance people's quality of life.

Looking ahead, NEC plans to expand provision of the FonesVisuas Test internationally, particularly in the APAC region, underscoring its commitment to advancing global healthcare standards.

(*1)https://royal-healthcare.com/
(*2)https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases https://www.who.int/news-room/fact-sheets/detail/dementia
(*3)https://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-2023_7a7afb35-en

About NEC

The NEC Group leverages technology to create social value and promote a more sustainable world where everyone has the chance to reach their full potential. NEC Corporation was established in 1899. Today, the NEC Group’s approximately 110,000 employees utilize world-leading AI, security, and communications technologies to solve the most pressing needs of customers and society.

For more information, please visit https://www.nec.com, and follow us on Instagram, Facebook, YouTube, and LinkedIn.