TOKYO and RAHWAY, N.J., Apr 21, 2026 - (JCN Newswire) - Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada), and Eisai (Headquarters: Tokyo, CEO: Haruo Naito) today announced results from the Phase 3 LITESPARK-012 trial evaluating combination treatments for the firstline treatment of patients with advanced clear cell renal cell carcinoma (RCC). The trial evaluated the triplet therapy of KEYTRUDA® (pembrolizumab), Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus WELIREG® (belzutifan), Merck & Co., Inc., Rahway, NJ, USA’s first-in-class hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. The study also evaluated MK-1308A, the coformulation of KEYTRUDA and quavonlimab, Merck & Co., Inc., Rahway, NJ, USA’s investigational anti-CTLA-4 antibody, plus LENVIMA. Both combination regimens were compared to KEYTRUDA plus LENVIMA for these patients.

At a pre-specified interim analysis, the combination regimens did not meet the dual primary endpoints of progression-free survival (PFS) and overall survival (OS) for the first-line treatment of patients with RCC compared to KEYTRUDA plus LENVIMA. The safety profiles of the combination regimens were consistent with those observed in previously reported studies evaluating the individual medicines and the KEYTRUDA plus LENVIMA combination. A full evaluation of the data from this study is ongoing, and Merck & Co., Inc., Rahway, NJ, USA and Eisai will work with investigators to share the results with the scientific community.

“With the LITESPARK-012 trial, we explored whether combining therapies with established activity could improve upon well-established standards set by KEYTRUDA-based regimens, reflecting our commitment to continuously explore ways to improve outcomes for the kidney cancer community,” said Dr. M. Catherine Pietanza, Vice President, Global Clinical Development, MSD Research Laboratories. “While these regimens did not demonstrate the results we hoped, the data deepen our understanding of advanced renal cell carcinoma and will help shape the next generation of treatment approaches.”

“While we are disappointed that LITESPARK-012 did not meet its primary endpoints, the findings reinforce the central role of KEYTRUDA plus LENVIMA in the first-line treatment of patients with advanced renal cell carcinoma,” said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. “Findings from trials such as this play an important role in shaping health care providers’ perspectives as the treatment paradigm for advanced renal cell carcinoma continues to evolve. We are committed to advancing the care of people living with this disease and we are grateful to the patients, caregivers and investigators whose participation and dedication made this research possible.”

Results from the LITESPARK-012 trial do not affect other ongoing trials from the LITESPARK clinical program, including those conducted jointly with Eisai. As previously announced, the U.S. Food and Drug Administration (FDA) has accepted two supplemental New Drug Applications (sNDA) for review based on Phase 3 LITESPARK-011 trial evaluating WELIREG in combination with LENVIMA for certain previously treated patients with advanced RCC and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct 4, 2026.

KEYTRUDA is currently approved as adjuvant monotherapy and in combination regimens for appropriate patients with RCC in the U.S., European Union (EU), Japan and other countries around the world.

KEYTRUDA plus LENVIMA is approved in the U.S., the EU, Japan and other countries for the firstline treatment of adult patients with advanced RCC. Lenvatinib is approved as KISPLYX for advanced RCC in the EU.

LENVIMA in combination with everolimus is approved in the U.S., EU and other regions for the treatment of adult patients with advanced RCC following one prior anti-angiogenic therapy.

WELIREG is approved in the U.S., EU, Japan and other countries for the treatment of adult patients with advanced clear cell RCC following a PD-1/PD-L1 inhibitor and 1-2 VEGF-TKIs based on results from the Phase 3 LITESPARK-005 trial.

About LITESPARK-012

LITESPARK-012 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04736706) evaluating either the triplet therapy of KEYTRUDA plus LENVIMA plus WELIREG or MK-1308A plus LENVIMA compared to KEYTRUDA plus LENVIMA for the first-line treatment of patients with advanced clear cell RCC. The primary endpoints are PFS, as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and OS. Secondary endpoints are objective response rate and duration of response as assessed by BICR according to RECIST v1.1, as well as safety. The study enrolled 1,688 patients who were randomized to receive:

• KEYTRUDA (400 mg intravenously [IV] every six weeks [Q6W]) plus LENVIMA (20 mg orally once daily [QD]) plus WELIREG (120 mg orally QD);
• MK-1308A (coformulation of pembrolizumab [400 mg] and quavonlimab [25 mg] IV Q6W) plus LENVIMA (20 mg orally QD);
• KEYTRUDA (400 mg IV Q6W) plus LENVIMA (20 mg orally QD).

All study drugs were continued until protocol-specified discontinuation criteria. KEYTRUDA and MK-1308A were administered for up to two years (approximately 18 cycles). WELIREG and LENVIMA may have been administered in combination or as a single agent until progressive disease or discontinuation.

About renal cell carcinoma

Renal cell carcinoma is the most common type of kidney cancer, with about nine out of 10 kidney cancer diagnoses being RCC. In 2022, there were about 435,000 new cases of kidney cancer diagnosed and approximately 156,000 deaths from the disease worldwide. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases, and about 70% are a form called clear cell RCC, which tends to be more aggressive and faster spreading. Approximately 30% of patients with kidney cancer are diagnosed at an advanced stage. 

About Merck & Co., Inc., Rahway, NJ, USA’s research in genitourinary cancers

Merck & Co., Inc., Rahway, NJ, USA is advancing research aimed at helping transform the treatment landscape and broaden options for people with genitourinary (GU) cancers, including bladder, kidney and prostate cancers. Globally, GU cancers account for an estimated 2.6 million new cancer diagnoses each year, equaling over 1 in 8 of all cancer incidences. Through a robust clinical development program with more than 50 ongoing clinical trials evaluating more than 22,000 patients around the world, Merck & Co., Inc., Rahway, NJ, USA is investigating the potential of several portfolio medicines and pipeline assets, leveraging multiple novel combination strategies, across various stages of disease, to help address unmet needs in GU cancers.

About KEYTRUDA® (pembrolizumab) injection for intravenous use, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck & Co., Inc., Rahway, NJ, USA has the industry’s largest immuno-oncology clinical research program. There are currently more than 2,800 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

About LENVIMA® (lenvatinib); available as 10 mg and 4 mg capsules

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 antiangiogenic 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); available as 40 mg tablets, for oral use

WELIREG, Merck & Co., Inc., Rahway, NJ, USA’s 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) disease-associated 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.

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

In March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA, known as MSD outside of the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and cocommercialization 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 positions Oncology as one of its key strategic areas, and aims to contribute to the cure of cancers through the discovery of innovative new drugs with new targets and mechanisms of action under the Deep Human Biology Learning (DHBL) drug discovery and development organization. By utilizing biomarker data obtained from our products to elucidate the mechanisms of the incidence and root causes of cancer, as well as drug resistance, and using Eisai Group's precision chemistry technology to turn undruggable intracellular therapeutic targets into druggable ones, we will create new backbone therapeutic drugs.

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 20 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 Merck & Co., Inc., Rahway, NJ, USA

At Merck & Co., Inc., Rahway, NJ, USA, known as MSD 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.merck.com and connect with us on  X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

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 and CAMBRIDGE, Mass., Mar 23, 2026 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that new real‑world findings from an analysis of long‑term treatment persistence and baseline characteristics among people receiving intravenous (IV) lecanemab (generic name, brand name LEQEMBI®), an anti‑amyloid‑β (Aβ) protofibril antibody, showed that most patients continue with ongoing lecanemab therapy after the initial 18 months of treatment. The analysis was presented at the 20th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2026) in Copenhagen, Denmark, and online.

In real‑world clinical practice, patients with chronic diseases who stay on their treatments longer tend to experience better clinical outcomes and higher satisfaction.1,2 Ninety-four percent of patients who completed 18 months of lecanemab treatment in the Phase III Clarity AD chose to continue maintenance treatment by enrolling in the subsequent open-label, long-term extension (OLE) study. In the OLE of Clarity AD study, patients continue to benefit from four years of lecanemab treatment compared with the natural course of Alzheimer’s disease (Alzheimer’s Disease Neuroimaging Initiative: ADNI*).

Long-Term Persistence and Patient Characteristics for Lecanemab in Real-World Use in the United States (Presentation: March 20, 17:05 CET)

This analysis is the first time real-world lecanemab data on treatment persistence beyond 18 months has been reported.

This study was a retrospective observational analysis using the PurpleLab® CLEAR Claims database, a comprehensive dataset based on medical insurance claims across the United States and was conducted to evaluate the long‑term treatment persistence of lecanemab in real‑world clinical practice.

Patient background and dosing 

The analysis population consisted of 10,763 individuals who met the requirement for continuous healthcare encounters, out of the 13,388 individuals recorded in the database who received at least one intravenous treatment with lecanemab between January 6, 2023 and November 30, 2025. At baseline, the mean age was 73.8 years and 56.5% were female. The most common comorbidities were dyslipidemia (42.2%) and hypertension (36.9%). The mean follow-up duration was 350.9 days. The average number of administrations was 1.7 per month, and the mean dosing interval was 16.4 days (median 14 days), which was generally consistent with the recommended every two weeks dosing.

Long-Term persistence results 

The time-dependent proportion of patients who remained on lecanemab treatment was evaluated, using the Kaplan–Meier method in a subgroup of 371 patients who initiated treatment in 2023 and had 20 months of continuous follow-up, thereby enabling assessment of long-term treatment persistence beyond 18 months. As a result, 78.4% of individuals continued lecanemab treatment at 18 months, 71.7% at 20 months, and 67.3% at 24 months. Of the 78.4% of patients who remained on lecanemab at 18 months, the majority of them continued treatment during the maintenance period beyond 18 months, confirming a high rate of treatment persistence with lecanemab in real-world clinical practice. The patient characteristics and dosing patterns observed in this claims-based analysis were generally similar to those reported in the Clarity AD. Furthermore, the relatively high treatment adherence observed among individuals suggests that potential delays due to MRI monitoring requirements, adverse events, and other factors did not substantially affect lecanemab dosing.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

* ADNI is a clinical research project launched in 2005 to develop methods to predict the onset and progression of AD and to confirm the effectiveness of treatments. The project involves a multi-year longitudinal observation targeting healthy elderly individuals as well as patients with mild cognitive impairment (MCI) and early stages of AD.

About lecanemab (generic name, brand name: LEQEMBI)

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab has been approved in 53 countries and regions including Japan, the United States, China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in 7 countries including the U.S., China, the UK, and others, and applications have been filed in 10 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A Supplemental Biologics License Application (sBLA) for initiation treatment was accepted in January 2026. The sBLA has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of May 24, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In December 2025, Lecanemab (IV) has been included in the “Commercial Insurance Innovative Drug List”, recently introduced by the National Healthcare Security Administration (NHSA) of China.

In the global Phase 3 placebo-controlled, double-blind, parallel-group, randomized Clarity AD core study, the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale. To provide context, a change from 0.5 to 1 on the Clinical Dementia Rating (CDR) score domains of Memory, Community Affairs and Home/Hobbies reflects a shift from mild impairment to loss of independence. This can affect a person’s ability to be left alone safely, recall recent events, participate in daily activities, manage household tasks, and engage in hobbies and intellectual interests.3,4

Over three years of treatment, including both the core study and the OLE, data showed lecanemab demonstrated a reduction in cognitive decline—measured by CDR-SB—of 1.01 points compared to the expected decline observed in the Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohort. This benefit grew more pronounced after four years, with a reduction of 1.75 points. Similarly, when benchmarked against the expected decline in the BioFINDER** cohort, lecanemab showed a reduction of 1.40 points at three years and an even greater reduction of 2.17 points at the four years mark.

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

** BioFINDER subjects are similar to Study 301 and ADNI subjects, except all BioFINDER subjects are in the MCI stage and no mild AD subjects are included, and their baseline CDR-SB is lower. BioFINDER is a largescale, long-term prospective study led by Lund University in Sweden, aiming to establish early. diagnosis and elucidate pathophysiology of neurodegenerative diseases. In addition to AD, the study also focuses on conditions including Parkinson's Disease. Individuals participating in the study undergo regular clinical assessments, cognitive function tests, brain imaging (MRI, Aβ PET, Tau PET), and collection of biomarkers from blood and cerebrospinal fluid (CSF).

About Protofibrils

Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of soluble Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.3 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.4

About the Collaboration between Eisai and Biogen for AD

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

About the Collaboration between Eisai and BioArctic for AD

Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.

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. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube

MEDIA CONTACTS

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

Eisai Europe, Ltd.(Europe, Australia, New Zealand and Russia)
EMEA Communications Department
+44 (0) 7739-600-678
EMEA-comms@eisai.net

Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
Libby_Holman@Eisai.com

Biogen Inc.
Madeleine Shin
+1-781-464-3260
public.affairs@biogen.com

INVESTOR CONTACTS

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

Biogen Inc.
Tim Power
+ 1-781-464-2442
IR@biogen.com

Biogen Safe Harbor

This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (marketed as LEQEMBI); the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI); the potential to expand options and reduce healthcare resources by treating Alzheimer's disease at home; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosure

From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

(1) Guerci B et al. Lack of treatment persistence and treatment nonadherence as barriers to glycaemic control in patients with type 2 diabetes. Diabetes Therapy, 2019; 10(2), 437-449.
(2) Menditto E et al. Persistence as a robust indicator of medication adherence-related quality and performance. International journal of environmental research and public health, 2021; 18(9), 4872.
(3) Cohen S., et al. J Prev Alzheimers Dis.2022;9(3):507-522.
(4) Morris JC. Neurology. 1993;43(11):2412-4.
(5) Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021; 12:3451. doi:10.1038/s41467-021-23507-z
(6) Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.

TOKYO, Mar 19, 2026 - (JCN Newswire) - Eisai Co., Ltd. announced today that the administration of the anticancer agent EZH2 inhibitor “Tazverik® Tablets 200 mg” (generic name: tazemetostat hydrobromide), which is manufactured and marketed in Japan by Eisai should be discontinued. We plan to discontinue sales of this product once we have confirmed that it is no longer being administered to any patients.

Following the announced voluntarily withdrawal of this product in the United States and other countries, Eisai has been collecting and reviewing safety data, including from the overseas clinical trials including SYMPHONY-1*1 and postmarketing data both domestic and from overseas. Based on the review of the available safety data, multiple cases of secondary hematologic malignancies have occurred on both combination and monotherapy treatment with tazemetostat.

After a comprehensive evaluation of these findings, we concluded that it is necessary to give the fullest possible consideration to the risk of secondary hematologic malignancies occurring even under the approved conditions of use in Japan.

Prioritizing patient safety, we are communicating with medical institutions in Japan where the drug is prescribed to consider discontinuing Tazverik immediately for patients currently receiving it, and to refrain from initiating any new administration.

Eisai will continue to make every effort to provide timely and appropriate information to healthcare professionals to prevent any confusion or disruption for medical institutions or patients.

The SYMPHONY‑1 study is a phase 1b/3 trial evaluating whether adding tazemetostat to rituximab plus lenalidomide (R2 therapy), the standard second ‑ line treatment, prolongs progression ‑ free survival (PFS) in patients with relapsed/refractory follicular lymphoma who have received at least one prior chemotherapy regimen*2. The phase 1b portion is a single‑arm dose‑finding study. In the phase III trial, eligible patients will be randomized 1:1; the experimental group will receive R2 therapy plus tazemetostat for 12 months, followed by up to 2 years of tazemetostat monotherapy. The control group will receive a placebo instead of tazemetostat. The primary endpoint is PFS; secondary endpoints are objective response rate (ORR), overall survival (OS), duration of response (DOR), health-related quality of life (HR-QOL), and safety. This trial is being conducted under Ipsen's leadership as the confirmatory trial required for the accelerated approval of Tazverik for follicular lymphoma in the United States and China, and is being carried out at 229 sites in 15 countries, including the United States, the European Union, and China (no sites in Japan are participating).

(1) Regarding the SYMPHONY-1 trial
(2) The indication approved for Tazverik in Japan is monotherapy for "relapsed or refractory EZH2 mutation–positive follicular lymphoma (limited to cases where standard treatment is difficult)."

About tazemetostat hydrobromide (generic name, product name “Tazverik Tablets 200 mg”)

Tazemetostat is a first-in-class, oral small molecule inhibitor that targets EZH2 that was jointly researched and developed under the alliance agreement between Eisai and Epizyme, Inc., an Ipsen company, utilizing Epizyme, Inc.'s proprietary product platform. This agent selectively inhibits EZH2 in a competitive matter with S-adenosylmethionine (a methyl group donor) to suppress methylation of H3K27. Eisai was granted exclusive rights for development and commercialization of this agent in Japan.

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

TOKYO, Mar 12, 2026 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it is launching an initiative to raise public awareness of the importance of sleep in collaboration with the smartphone application “Pokémon Sleep”.

It is estimated that 12.4 million adults in Japan—equivalent to 11.8% of the adult population—experience insomnia and the resulting daytime functional impairments.1 According to the 2023 National Health and Nutrition Survey by the Ministry of Health, Labour and Welfare, the percentage of people aged 20 and older who feel they have sufficient rest through sleep has shown a gradual decline, highlighting a consistent downward trend for over a decade.2 The proportion of people who sleep less than six hours per night has also reached 38.5% among men and 43.6% among women.2

The feeling of insufficient rest has been linked to decreased daytime performance and an increased risk of lifestyle-related diseases, and securing adequate sleep in terms of both quality and quantity is essential for health promotion and maintenance across all age groups.3 Accordingly, the importance of educational activities aimed at disseminating accurate sleep knowledge is increasing.

This initiative is part of Eisai’s efforts to build an ecosystem in the sleep field, a key focus area for the company. By leveraging Eisai’s scientific expertise in sleep and the ability of “Pokémon Sleep” to “inspire action through fun”, the collaboration aims to create opportunities for all generations to reflect on their own sleep and daytime performance, and subsequently raise awareness of the importance of healthy sleep.

As the first step of this collaborative awareness initiative, Eisai will provide the picture book “Snorlax’s Dream” to medical institutions across Japan that are actively involved in sleep disorder consultation, primarily to those registered with “Sleep Consultation Navigator” information site powered by Eisai. The story is set in the world of “Pokémon Sleep”. Through an adventure in search of Snorlax, the Pokémon characters convey the “importance of getting sufficient sleep and staying healthy” and “tips for a good sleep” in an entertaining way to readers of all ages. By making the picture book available in the waiting areas of medical institutions, the initiative aims to encourage patients to reflect on their own sleep habits in an environment where they are more likely to be considering their physical condition and lifestyle. Additionally, under the collaboration with Pokémon Sleep, Eisai plans to expand its awareness activities by updating patient education leaflets and creating video content that promotes healthy sleep habits.

(Please note that all materials provided are intended for distribution to medical institutions in Japan.)

Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities not only through the development of therapeutic drugs, but also by building an ecosystem in collaboration with other industries. Together with “Pokémon Sleep,” Eisai will continue to create an environment where people of different generations can reflect on their sleep habits and achieve positive behavioral changes toward a healthy lifestyle. Through these efforts, Eisai will further contribute not only to individuals living with insomnia and their families but also to those who have concerns about their sleep.

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

About “Pokémon Sleep”

Pokémon Sleep, the sleep tracker app that turns sleep into entertainment, can be downloaded for free on the Apple App Store or Google Play Store. Learn more about Pokémon Sleep at PokemonSleep.net.

[Product Information]
Title: Pokémon Sleep
MSRP: Free to play *Features in-app purchases
Publisher: The Pokémon Company
Developer: SELECT BUTTON Inc.
Platforms: iOS/Android
Genre: Simulation
Mode: Single-player
Supported languages: Japanese, English, Spanish, French, German, Italian, Korean, Traditional Chinese
*The "Spanish" supported by this software is European Spanish.
[Official website]
https://www.pokemonsleep.net/en/
[App store]
https://app.adjust.com/1xkxcsv1
[Copyright]
©Pokémon/Nintendo/Creatures/GAME FREAK
Pokémon Sleep is developed by SELECT BUTTON inc.
TM, ®, and character names are trademarks of Nintendo.

The Pokémon Company was established to manage the Pokémon brand. Currently, the company develops and produces video games, which is where Pokémon originates, as well as trading card games, animated TV series and movies, merchandise, tie-up promotions, events, and the Pokémon Center, directly managed Pokémon shops.

About the Sleep Information Website Operated by Eisai 

Eisai provides basic knowledge about sleep and insomnia, self-checks for sleep, information about treatments and medications for insomnia, through "Sodan.e-Nemuri". Additionally, the website offers a wide range of content about sleep for those struggling with sleep issues, including the "Sleep Consultation Navigator" which helps users search for medical institutions that can provide advice and treatments for sleep disorders and insomnia. Please see https://e-nemuri.eisai.jp/ for details. (Japanese only)

References

1. Clinical Guideline for the Management and Treatment of Sleep Disorders, 3rd Edition (Japanese only)
2. The 2023 National Health and Nutrition Survey by the Ministry of Health, Labour and Welfare (Japanese only) https://www.mhlw.go.jp/content/10900000/001338334.pdf
3. Sleep Guide for Health Promotion 2023 - Ministry of Health, Labour and Welfare (Japanese only) https://www.mhlw.go.jp/content/001305530.