Poxel Announces Positive Preclinical Data for PXL065 in Hypertrophic Cardiomyopathy To Be Presented at the ESC Congress 2025




Poxel Announces Positive Preclinical Data for PXL065 in Hypertrophic Cardiomyopathy To Be Presented at the ESC Congress 2025

• PXL065 demonstrated significant benefits in a HCM mouse model preventing pathological myocardial remodeling, including hypertrophy and fibrosis in the heart
• Presentation of detailed results from preclinical study on Sept 1^st, 2025, 11:15 am CEST, at the European Society of Cardiology 2025
• Findings support the clinical development of PXL065 as a potential disease- modifying treatment for symptomatic and asymptomatic HCM patients

LYON, France–(BUSINESS WIRE)–Regulatory News: 

POXEL SA (Euronext : POXEL – FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare metabolic disorders, today announces that the abstract featuring previously announced preclinical data demonstrating positive results for PXL065, the deuterium-stabilized R-enantiomer of pioglitazone, in hypertrophic cardiomyopathy¹, has been accepted for presentation at the 2025 edition of the European Society of Cardiology (ESC) Congress (link), to be held jointly with World Congress of Cardiology, on September 1^st, 2025 at 11:15 am CEST, in Madrid, Spain.

Prof. Dr. Cordula Wolf, Director of the Center for Rare Congenital Heart Diseases at the TUM University Hospital German Heart Center, stated: “The compelling results obtained in this study illustrate the potential of PXL065 in HCM, the most common genetic cardiac disorder. Current treatments have important limitations in efficacy, safety, or patient applicability. There is a clear unmet need for safe and effective disease-modifying therapies.”

Thomas Kuhn, CEO of Poxel, added: ”We are pleased to have the data with PXL065 in HCM be presented at one of the world’s leading forums for cardiovascular science and medicine, which underscores both the quality and relevance of these findings. We look forward to further supporting PXL065 development for the treatment of HCM based on these promising results.”

Hypertrophic Cardiomyopathy (HCM) is a genetic disorder marked by myocardial hypertrophy, cardiac fibrosis, ventricular dysfunction, arrhythmias, and an increased risk of sudden cardiac death. It is caused by mutations in sarcomere protein genes, leading to altered cell metabolism, including oxidative stress and mitochondrial dysfunction. The estimated prevalence of HCM is 0.2%, or 1/500 adults, and its incidence is around 5 per 100,000 person-years.

In connection with the mechanism of action of PXL065 on the inhibition of the mitochondrial pyruvate carrier (MPC) and on the inhibition of Acyl CoA Synthetase 4 (ACSL4) thus acting on oxidative stress, inflammation and fibrosis, PXL065 was successfully assessed in an established mouse model of hypertrophic cardiomyopathy.

This preclinical study was funded by the German Center for Cardiovascular Research (DZHK) and conducted at the TUM University Hospital German Heart Center by leading HCM expert Prof. Dr. Cordula Wolf. Poxel and the TUM University Hospital German Heart Center collaborated on the pre-clinical study based on Poxel’s existing data and patent portfolio on PXL065 and prior research conducted by Prof. Dr. Cordula Wolf and her group on the disease mechanisms and therapeutic use of TZD’s in HCM.

About Poxel SA

Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including metabolic dysfunction-associated steatohepatitis (MASH) and rare disorders. For the treatment of MASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG^® (Imeglimin), Poxel’s first-in-class product that targets mitochondrial dysfunction, is now marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.

For more information, please visit: www.poxelpharma.com

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.

¹ Press release as of March 20, 2025

Contacts

Investor relations / Media
NewCap

Aurélie Manavarere, Théo Martin / Arthur Rouillé

investors@poxelpharma.com
+33 1 44 71 94 94

Eurofins: Purchases of Own Shares From May 19th to May 23th 2025




Eurofins: Purchases of Own Shares From May 19th to May 23th 2025

LUXEMBOURG–(BUSINESS WIRE)–Regulatory News:

Eurofins (Paris:ERF):

Transaction details

In accordance with Article 5(1)(b) of Regulation (EU) N° 596/2014 (the Market Abuse Regulation) a full breakdown of the individual trades are disclosed on Eurofins Scientific SE website: https://www.eurofins.com/investors/share-buy-back-programmes

Contacts

Eurofins

VISTA Inhibitor Clinical Trials Market Insights and Drug Development Opportunities Report 2025-2028 Featuring Aurigene, Curis, Hummingbird Bioscience, Kineta, PharmAbcine, Sensei Biotherapeutics – ResearchAndMarkets.com




VISTA Inhibitor Clinical Trials Market Insights and Drug Development Opportunities Report 2025-2028 Featuring Aurigene, Curis, Hummingbird Bioscience, Kineta, PharmAbcine, Sensei Biotherapeutics – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “VISTA Inhibitor Clinical Trials, Drug Development Opportunities & Patent Insight 2025” report has been added to ResearchAndMarkets.com’s offering.

The landscape of cancer immunotherapy has witnessed remarkable transformations in recent years, with immune checkpoint inhibitors revolutionizing treatment approaches for various malignancies. With the massive success of first generation immune checkpoint inhibitors, such as pembrolizumab and Nivolumab, researchers have now focused their efforts in identifying newer immune checkpoint proteins. Among the emerging next-generation targets in this innovative field is the V-domain immunoglobulin suppressor of T cell activation (VISTA), which represents a promising yet under-explored avenue for potential therapeutic interventions across a range of indications.

VISTA, a critical immune checkpoint protein, plays a nuanced role in regulating immune responses, particularly within the tumor microenvironment. Unlike more extensively studied checkpoint molecules like PD-1 and CTLA-4, VISTA remains a relatively nascent target with significant untapped potential. Researchers have increasingly recognized its importance in modulating T cell activation and suppressing anti-tumor immune responses, making it an intriguing candidate for targeted immunotherapeutic strategies.

The current immunotherapy landscape demonstrates considerable promise for VISTA targeted approaches, drawing parallels with the remarkable success of existing immune checkpoint inhibitors. The groundbreaking achievements of PD-1 and CTLA-4 inhibitors have paved the way for more sophisticated and precise immunomodulatory interventions. These precedents provide robust scientific validation and investor confidence in exploring novel checkpoint targets like VISTA, suggesting a potentially transformative therapeutic approach.

Among the most promising developments in VISTA targeted therapy is CA-170, an innovative oral small molecule developed by Aurigene Oncology and Curis. This compound represents a sophisticated dual inhibitor targeting both VISTA and PD-L1, offering several compelling advantages over traditional antibody-based approaches. The molecule’s oral administration format, reduced complexity, and potential for more manageable immune-related adverse events distinguish it from conventional immunotherapeutic strategies.

The strategic collaboration between Aurigene and Curis highlights the significant interest and potential commercial viability of VISTA targeted therapies. By dividing development rights across different geographical regions, the partnership underscores the global scientific community’s recognition of VISTA’s therapeutic potential. The ongoing late-phase clinical trials, particularly the phase 2b/3 studies investigating CA-170’s efficacy in non-small cell lung cancer, represent a critical milestone in understanding the molecule’s clinical utility.

Preclinical and early stage research has unveiled VISTA’s complex immunomodulatory mechanisms. Unlike some checkpoint proteins, VISTA exhibits unique characteristics in suppressing T cell responses, suggesting nuanced implications for cancer immunotherapy. Preliminary studies indicate that VISTA’s inhibition could potentially reinvigorate anti-tumor immune responses, offering a complementary or alternative approach to existing checkpoint blockade strategies.

The lack of approved VISTA-targeted therapies presents both a challenge and an opportunity for researchers and pharmaceutical developers. The uncharted nature of this therapeutic domain invites innovative approaches and allows for creative exploration of VISTA’s potential mechanisms. Researchers are particularly intrigued by VISTA’s potential in overcoming resistance mechanisms observed with other checkpoint inhibitors, potentially offering new hope for patients with treatment-resistant malignancies.

Scientific interest in VISTA extends beyond oncology, with emerging research suggesting potential applications in autoimmune disorders and inflammatory conditions. This broader therapeutic landscape further amplifies the molecule’s significance and underscores the importance of continued investigative efforts. The multifaceted nature of VISTA’s immunomodulatory functions presents a complex yet exciting frontier for translational research.

As the scientific community continues to unravel VISTA’s intricate roles in immune regulation, the coming years are likely to witness accelerated research and clinical development. The potential for developing targeted therapies that can modulate immune responses with greater precision represents a significant advancement in personalized medicine. While challenges remain, the foundational research and ongoing clinical investigations paint an optimistic picture for VISTA-targeted therapeutic strategies.

Report Highlights & Findings:

• First VISTA Inhibitor Drug Approval By 2028
• US Dominating Global VISTA Inhibitor Clinical Trials Landscape
• Insight On Ongoing Clinical Trials By Company, Country, Indication & Phase
• Key Drugs Clinical Study Initiation & Completion Year Overview
• Global & Regional Market Development Insight By Indication
• Global VISTA Inhibitors Market Dynamics & Competitive Landscape

Key Topics Covered:

1. VISTA As Emerging Immune Checkpoint

1.1 What Is VISTA Inhibition?

1.2 Structure & Biology Of VISTA Protein

1.3 Mechanism Of Action Of VISTA Inhibitors

2. VISTA As Inhibitory & Costimulatory Checkpoint

2.1 VISTA As Inhibitory Immune Checkpoint

2.2 VISTA As Costimulatory Checkpoint

2.3 VISTA Inhibition v/s Conventional Immune Checkpoint Inhibitors

3. Significance Of VISTA In Disease Progression & Cure

3.1 Role Of VlSTA In Facilitating Cancer Progression

3.2 VISTA As Potential Cancer Biomarker

3.3 VISTA As Therapeutic Target In Autoimmune Diseases

4. Global VISTA Inhibitors Market & Clinical Development Outlook

4.1 Current Scenario

4.2 Future Opportunities

5. VISTA Targeted Therapies Trends & Clinical Innovation By Indication

5.1 Solid Cancers

5.2 Hematological Cancers

5.3 Autoimmune & Inflammatory Disorders

6. VISTA Targeted Therapies Trends & Clinical Innovation By Region

6.1 US

6.2 Europe

6.3 India

6.4 Australia

7. Global VISTA Inhibitors Clinical Trials Overview

7.1 By Country

7.2 By Indication

7.3 By Organization

7.4 By Phase

8. Global VISTA Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase

8.1 Preclinical

8.2 Phase I

8.3 Phase I/II

8.4 Phase III

9. Global VISTA Inhibitors Market Dynamics

9.1 Market Drivers

9.2 Market Challenges

10. Competitive Landscape

10.1 Aurigene Discovery Technologies

10.2 Curis

10.3 Hummingbird Bioscience

10.4 Kineta

10.5 PharmAbcine

10.6 Sensei Biotherapeutics

For more information about this report visit https://www.researchandmarkets.com/r/rtyaoe

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20




Huonslab Achieves Last-Patient-In (LPI) in Phase 1 Pivotal Study for Recombinant Human Natural Hyaluronidase PH20

• Phase 1 Pivotal Study in Korea for HLB3-002
• Plans to apply for marketing approval with the MFDS by the 2H 2025

PANGYO, South Korea–(BUSINESS WIRE)–#Allergenicity—Huonslab Co., Ltd. (“Huonslab”), a subsidiary of Huons Global (KOSDAQ:084110) has announced the successful completion of patient enrollment in its pivotal phase 1 clinical trial of Hydizyme™ (recombinant human natural hyaluronidase PH20; rHuPH20; HLB3-002), marking a significant milestone in the ongoing HLB3-002 development program. HLB3-002 Phase 1 Study (NCT06713317) was designed to evaluate the safety and allergenicity of HLB3-002 in 243 healthy volunteers.

The study is being conducted as a two-part, randomized, double-blind, placebo-controlled study. The first part focuses on evaluating allergenicity of HLB3-002 upon single intradermal administration of HLB3-002, while the second part focuses on evaluating safety of HLB3-002 upon single subcutaneous administration. The study is ongoing at four leading medical institutions in South Korea, known for their excellence in clinical research: Seoul National University Hospital, Asan Medical Center, Konkuk University Medical Center, and Chung-Ang University Hospital. The participating sites were selected to support consistent trial conduct and participant recruitment.

Huonslab expects to submit a Biological License Application (BLA) for marketing approval with the MFDS by the second half of this year, pending trial outcomes.

Huonslab’s official said, “This milestone represents an important step in advancing the HLB3-002 development program. The results of this phase 1 will provide Huonslab with important insights into the safety and allergenicity profile of HLB3-002, laying a solid foundation for future clinical trials and regulatory submission.”

In April, Huonslab attracted much attention at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025), held in Chicago, when the company announced the result of formulation conversion using recombinant human hyaluronidase HLB3-002 in a poster presentation.

About Huonslab

Huonslab, a South Korean biologics R&D leader and subsidiary of Huons Global (KOSDAQ:084110), is a fast-paced Bio, Pharmaceuticals & Healthcare business holding company with more than 2,200 employees, worldwide.

Huonslab was established in 2018 to innovate human hyaluronidase-based biologics for subcutaneous (SC) delivery. Its proprietary HyDIFFUZE™ platform, manufactured with a recombinant CHO cell line and patented process, offers a patient-friendly and economical alternative to traditional intravenous (IV) delivery by streamlining SC administration of various therapeutic modalities.

Contacts

Media Contact
Dr. Byung Ha Lee

Chief Business Officer

blee@huonslab.com

Pharma Industry Turns to Research and Markets Amid AI Boom and Rising Demand for Trusted Intelligence




Pharma Industry Turns to Research and Markets Amid AI Boom and Rising Demand for Trusted Intelligence

DUBLIN–(BUSINESS WIRE)–Research and Markets, the world’s leading source for international market research reports and data, has seen a surge in demand for its services from pharmaceutical and healthcare companies, as the sector grapples with the disruptive pace of artificial intelligence (AI), regulatory shifts, and an overwhelming volume of market information.

With more than 650 publishing partners, Research and Markets stands apart as a trusted advocate for its clients. It helps global pharmaceutical companies navigate a fragmented, often confusing research landscape and make informed decisions with confidence. In a time when questions around quality, trust, and bias are front and centre, the company’s independent, client-first model is proving more valuable than ever.

“We’re not here to push a particular publisher. We’re here to help our clients find the intelligence that best suits their needs, whether that’s a global forecast from a top-tier provider or a specialist report from a niche supplier that’s hard to access anywhere else,” said Ross Glover, CEO of Research and Markets. “It’s about independence, experience, and a relentless focus on quality.”

From multinational pharmaceutical companies to emerging biotech firms, Research and Markets supports a broad range of organisations across the healthcare and life sciences sectors. Clients include leading drug manufacturers, contract research and manufacturing organisations, and healthcare-focused investors, all of whom rely on timely, credible market intelligence to guide strategy, innovation, and investment decisions.

Within those organisations, the platform is relied upon by a wide array of roles, including:

• Heads of Competitive Intelligence
• Directors of Market Research
• R&D and Pipeline Strategy Leads
• Corporate Librarians
• Business Development Executives
• Commercial and Marketing Directors
• Medical Affairs Managers
• Procurement and Vendor Management Professionals

Beyond providing access to a vast catalogue of research, Research and Markets also simplifies the procurement process. Clients benefit from a single point of access to hundreds of suppliers, reducing friction for purchasing teams, streamlining internal workflows, and ensuring compliance with procurement policies. This is particularly important for large, global organisations managing multiple business units and complex research needs.

“Procurement teams love that they don’t need to onboard dozens of niche suppliers individually,” said Glover. “With us, they have one contract, one relationship, and access to everything from mainstream to highly specialised intelligence.”

Key topics currently driving demand include:

• AI in Drug Discovery and Development
• Digital Therapeutics and Remote Patient Monitoring
• CDMO and CRO Market Trends
• Personalised Medicine and Genomics
• Cell and Gene Therapy Pipelines
• Regulatory Intelligence and Market Access
• Rare Disease and Orphan Drug Development

“Our role is to be a partner in progress,” added Glover. “We don’t just help clients buy research. We help them buy well. We understand the space, we know the sources, and we work hard every day to match organisations with insights that actually move their strategy forward.”

Contacts

For media enquiries or to learn more about our services for the pharma and healthcare industry, please contact:

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T. Office Hours Call 1-917-300-0470

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Stride and UNITY Fitness Announce Market-First Partnership, Redefining Personal Health Optimisation in Canada




Stride and UNITY Fitness Announce Market-First Partnership, Redefining Personal Health Optimisation in Canada

Industry-leading debut of Canada’s most advanced health and wellness model that combines advanced health diagnostics with a premium fitness and recovery membership experience.

TORONTO–(BUSINESS WIRE)–In a bold move set to reshape Canada’s health and wellness landscape, Stride — the digital-first leader in health optimisation — has partnered with UNITY Fitness Harbourfront, Toronto’s destination for holistic fitness and recovery, to launch the first integrated health enhancement membership of its kind in the Canadian market.

Launching May 29th, the new UNITY360 memberships will offer an unprecedented combination of advanced health diagnostics, personalised wellness services, and exclusive lifestyle perks — marking a significant step toward democratising elite wellness experiences.

A Preventative, Data-Driven Health Revolution

At the heart of this partnership is a shared mission: to shift the narrative from reactive care to proactive, preventative health. Powered by Stride’s comprehensive health optimisation ecosystem, UNITY360 members will now have access to a suite of best-in-class tests — including DNA, blood, gut biome, and methylation panels — alongside VO2 max and musculoskeletal assessments.

“This collaboration is about making optimal health accessible and actionable,” says Josh Allan, Director of Fitness and Athletics at UNITY. “The UNITY 360 membership is designed to prioritise health span over life span, providing our community with an all-encompassing and actionable approach to wellness. By housing fitness, recovery, and diagnostic health services under one roof, we will be able to truly personalise our support to members at all points of their wellbeing journey.”

Partnership Sets a New Standard for Health Optimisation in the Canadian Wellness Industry

This partnership marks the first time a Canadian wellness brand has integrated data-led health optimisation testing into a fitness membership offering — a model already gaining traction in global wellness hubs like Los Angeles and New York.

Andrew Steele, Stride’s CEO, adds, “At Stride, we believe in setting health standards, not just health goals. Through this partnership with UNITY, we’re bringing scientifically-backed, data-informed health insights directly to where people move, train, and recover. It’s about bringing optimal health to people where they are and giving them the tools to thrive.”

Providing An Elevated All-In-One Health Optimisation Membership

The enhanced UNITY 360 membership experience includes:

• StrideDNA: The ultimate health optimisation bundle testing of 9,000 genetic locations across 110 key genes, including MTHFR & COMT for enhanced resilience and longevity. Key reports include:
  • Methylation pathway profiles (e.g. folate cycle, methionine cycle)
  • Nutrient needs & sensitivities (e.g. carbohydrate response, vitamin needs, lactose intolerance predisposition)
  • Fitness markers (e.g. power/endurance balance, recovery efficiency, injury risk)
  • Cognitive insights (e.g. sleep quality, stress tolerance, chronotype)
  • Skin health (e.g. ageing predisposition, inflammation tendency, glycation sensitivity).

• StrideBiome: Testing microbiome diversity, bacterial balance, digestive efficiency, and neurotransmitter pathways. Advanced 16S rRNA sequencing of 70+ bacterial species across 31 genera. Key reports include:
  • Gut ecosystem diversity and balance assessment
  • Neurotransmitter production influences (e.g. serotonin, dopamine, GABA)
  • Digestive efficiency markers (e.g. nutrient absorption, barrier function)
  • Metabolic health indicators linked to weight management and energy regulation.

• VO2 max and Knee KG assessments.
• Quarterly Myodetox sessions at preferred rates.
• Priority booking privileges and personalised recovery plans.
• Exclusive access to workshops, events, and retail collaborations.
• Early access to StrideBloods (launching in Q2 of 2025): Testing 70+ Biomarkers across cardiovascular, hormonal, vital functions and longevity health markers.

With both brands approaching their first anniversary and experiencing rapid growth, the timing underscores a significant moment in Toronto’s wellness evolution.

“Our community of biohackers, athletes, and everyday wellness enthusiasts is craving deeper, more meaningful ways to optimise their health,” says Adam Reynolds, Director of Strategy and Operations at UNITY Fitness. “UNITY 360 is designed to support anyone passionate about upgrading their wellness, no matter where they are on their fitness journey.”

Launch Details

The program officially launches June 1st, with UNITY+ memberships available from June. Early member interest signals strong demand, with UNITY already boasting over 4,200 active members, including 1,280 corporate memberships.

Pricing Details

Prices start at $280+tax p/m (CAD) with a 12-month minimum commitment.

About Stride

Stride is a digital-first health optimisation company from the UK, revolutionising how people understand and optimise their health, fitness and longevity. On a mission to make tracking internal biomarkers as common as tracking wearable data, Stride has created the world’s most comprehensive health testing membership. Stride bridges the gap between proactive wellness and reactive healthcare by analysing over 250 biomarkers across DNA, microbiome, and bloods. Stride empowers individuals to unlock their health potential through combining these advanced tests with personalised protocols, expert support, tailored supplementation, and continuous optimisation. This integrated, data-driven approach reveals the complete picture of an individual’s internal biology, enabling truly personalised recommendations rather than generic health advice for measurable, long-term health optimisation.

For more information about Stride, please visit getstride.com

About UNITY Fitness

Located in the heart of Toronto’s Sugar Wharf district, UNITY Fitness Harbourfront is a 45,000 sq ft state-of-the-art wellness club designed to inspire and empower individuals on their fitness journeys. With premium equipment, boutique-style classes, and curated services, UNITY offers an inclusive environment where members can achieve their goals while fostering a sense of belonging. Amenities include a full-sized basketball court that doubles as two pickleball courts, a two-lane saltwater pool, an infrared hot yoga studio, and a cycling studio, catering to diverse needs and lifestyles. As a versatile neighbourhood hub, UNITY combines fitness spaces, lounge areas, and boutique studios, bringing people together to build community through movement.

For more information about UNITY, please visit joinunity.ca

Contacts

Stride / UNITY:

Natalie Elmitt

nataliee@jacktaylorpr.com

Rosie Davis

rosie@jacktaylorpr.com

Fluor-Built Pharmaceutical Facility in California is First Industrial Manufacturing Facility in Western United States to Achieve LEED v4 Platinum Certification




Fluor-Built Pharmaceutical Facility in California is First Industrial Manufacturing Facility in Western United States to Achieve LEED v4 Platinum Certification

Facility also named 2025 ISPE Facility of the Year Winner for Social Impact – Unmet Medical Needs

IRVING, Texas–(BUSINESS WIRE)–#FluorBuildsABetterWorld—Fluor Corporation (NYSE: FLR) announced today that Bayer’s Cell Therapy Launch Facility in Berkeley, California, has been designated the first industrial manufacturing facility in the Western United States to achieve Leadership in Energy and Environmental Design (LEED) v4 Platinum Certification. The project was also named the 2025 Facility of the Year for Social Impact – Unmet Medical Needs by the International Society for Pharmaceutical Engineering (ISPE).

LEED v4 Platinum certification is the highest level of recognition for sustainable building practices and indicates that a building meets the highest standards for sustainability.

Fluor’s scope of work included the engineering, procurement, construction management, commissioning, qualification and validation for the 144,000-square-foot, state-of-the-art facility. It features 30,000 square feet of cleanroom space dedicated to advancing cell therapy production for neurological degenerative disorders, cardiovascular disease and other unmet medical needs.

“Fluor and Bayer collaborated to deliver Bayer’s first fully electric pharmaceutical manufacturing plant, and we met an aggressive schedule to support client and patient needs,” said Richard Meserole, President of Fluor’s Advanced Technologies & Life Sciences business. “Fluor secured LEED v4 Platinum Certification and ISPE Facility of the Year designation through effective collaboration with our trade partners, lean construction methods, and dedication to quality.”

Sustainability benefits for the facility include 52.6% energy cost savings via LED, high-efficiency lighting, heat pump and rooftop solar installation. The facility boasts 100% process water reduction, 98% onsite management of rainfall high efficiency plumbing fixtures, 65% recycled content installation, high use of sustainable materials, land use maximization and various innovation credits.

This is the second new facility built by Fluor on Bayer’s Biotech campus in Berkeley. Previously, Fluor completed construction of Bayer’s state-of-the-art Single Use Technology biopharmaceutical manufacturing Cell Culture Technology Center in 2021.

About Fluor Corporation:

Fluor Corporation (NYSE: FLR) is building a better world by applying world-class expertise to solve its clients’ greatest challenges. Fluor’s nearly 27,000 employees provide professional and technical solutions that deliver safe, well-executed, capital-efficient projects to clients around the world. Fluor had revenue of $16.3 billion in 2024 and is ranked 265 among the Fortune 500 companies. With headquarters in Irving, Texas, Fluor has provided engineering, procurement and construction services for more than a century. For more information, please visit www.fluor.com or follow Fluor on Facebook, Instagram, LinkedIn, X and YouTube.

#atls

Contacts

Brett Turner

Media Relations

864.281.6976

Jason Landkamer

Investor Relations

469.398.7222

Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer




Zai Lab Receives U.S. FDA Fast Track Designation for ZL-1310, a DLL3-Targeted Antibody-Drug Conjugate, for Treatment of Extensive-Stage Small Cell Lung Cancer

– The Company is on track to initiate a pivotal study for ZL-1310 in small cell lung cancer (SCLC) in 2025

SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZL-1310, the Company’s potential first-in-class Delta-like ligand (DLL3) antibody-drug conjugate (ADC), for the treatment of extensive-stage small cell lung cancer (ES-SCLC). ZL-1310, which is being evaluated in an ongoing global Phase 1a/1b clinical trial (NCT06179069), previously received an Orphan Drug designation for SCLC from the FDA. The company will present updated data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

“The FDA’s decision to grant Fast Track designation to ZL-1310 highlights the significant need for expanded treatment options for patients with SCLC and represents an important step in our efforts to advance a novel therapeutic option as quickly as possible,” said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. “This designation reinforces the clinical progress we have achieved for ZL-1310 to-date, and we remain on track to initiate a pivotal study in small cell lung cancer later this year, positioning us for a potential accelerated approval in 2027.”

Fast Track designation facilitates the expedited development and review of new drugs to address an unmet medical need or treat serious or life-threatening diseases. Benefits of this designation include more frequent engagements with the FDA to discuss the drug’s clinical development plan and eligibility for Accelerated Approval and Priority Review if relevant criteria are met. More information on the Fast Track process is available here.

Zai Lab will hold an investor conference call and webcast to highlight updated ZL-1310 data at ASCO and outline the next steps in clinical development.

Details regarding upcoming ZL-1310 webcast and conference call are as follows:

Date/Time: Monday, June 2, 2025, at 7:00 a.m. CT / 8:00 a.m. ET / 8:00 p.m. HKT., please register at:

Webcast presentation (preferred): https://edge.media-server.com/mmc/p/jnqqzjod;
Dial-in: https://register-conf.media-server.com/register/BIc7326906f3764306accd7708d21d2ecb.

Presenter: Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab

About Small Cell Lung Cancer and ZL-1310

SCLC is one of the most aggressive and lethal solid tumors, accounting for approximately 5% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year. ^1,2 Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage. ³

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. ZL-1310 comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN^®, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

About Zai Lab

Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.X.com/ZaiLab_Global, www.twitter.com/ZaiLab_Global.

Zai Lab Forward-Looking Statements

This press release contains forward-looking statements relating to our future expectations, plans, and prospects, for Zai Lab, including, without limitation, statements relating to our prospects and plans for developing and commercializing next generation ADCs, including ZL-1310, the potential benefits of ZL-1310, and the potential treatment of SCLC and neuroendocrine tumors. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC’s website at www.sec.gov.

References:

¹ J Thorac Oncol. 2023 Jan;18(1):31-46; Lung Cancer Foundation of America.

² WHO Globocan 2022.

³ Sabari JK, et al. Nat Rev Clin Oncol. 2017;14:549-561.

Contacts

Investor Relations:
Christine Chiou / Lina Zhang

+1 (917) 886-6929 / +86 136 8257 6943

christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com

Media:
Shaun Maccoun / Xiaoyu Chen

+1 (857) 270-8854 / +86 185 0015 5011

shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Ionis announces positive topline results from Essence study of olezarsen in people with moderately elevated triglycerides




Ionis announces positive topline results from Essence study of olezarsen in people with moderately elevated triglycerides

– Olezarsen met the primary endpoint with a statistically significant mean reduction in triglycerides versus placebo at 80 mg and 50 mg doses –

– Olezarsen met all key secondary endpoints –

– Olezarsen demonstrated a favorable safety and tolerability profile –

– Nearly 1,500-person Phase 3 study supports the exposure database for olezarsen –

– Data from pivotal Phase 3 CORE and CORE2 studies of olezarsen in severe hypertriglyceridemia (sHTG) expected in Q3 2025 –

CARLSBAD, Calif.–(BUSINESS WIRE)–Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive topline results from the Essence study of olezarsen in people with moderate hypertriglyceridemia (fasting triglycerides ≥150 mg/dL to <500 mg/dL) with or at risk for atherosclerotic cardiovascular disease (ASCVD). Nearly all the participants were on current standard of care lipid-lowering medicines. The trial met its primary endpoint with a statistically significant placebo-adjusted 61% and 58% reduction in triglyceride (TG) levels at 6 months with the 80 mg and 50 mg monthly doses, respectively (p <0.0001). Olezarsen also met all key secondary endpoints in the study. The vast majority of participants reached <150mg/dL, reflecting a reduction to normal TG levels. Olezarsen demonstrated a favorable safety and tolerability profile in the study. Ionis plans to submit an abstract for presentation at an upcoming scientific conference. Data from the pivotal Phase 3 CORE and CORE2 studies evaluating olezarsen for the treatment of severe hypertriglyceridemia (sHTG) are expected in Q3 2025.

“The positive results of this study are an important step in bringing forward a potential new treatment for people with severely elevated triglycerides. Following the FDA approval and encouraging launch of TRYNGOLZA (olezarsen) for people living with familial chylomicronemia syndrome (FCS), a rare, genetic form of severely elevated TGs, these data support olezarsen’s potential to benefit the much broader population of people living with sHTG,” said Sam Tsimikas, M.D., senior vice president, global cardiovascular development at Ionis. “We look forward to seeing the results of our pivotal Phase 3 studies, CORE and CORE2, in Q3 2025, which will be the basis for our potential sNDA filing in sHTG by year-end.”

Olezarsen demonstrated a favorable safety and tolerability profile in the study. The most common treatment-emergent adverse event that occurred more frequently than placebo in the olezarsen groups was injection site reactions, with the majority being mild in severity.

About the Essence Study

The Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study (Essence-TIMI 73b), conducted with Ionis’ research partner, The TIMI Study Group, supports the exposure database for olezarsen (NCT05610280). Essence enrolled 1,478 participants aged 18 and older with moderate hypertriglyceridemia (HTG), defined as fasting triglyceride levels ≥150 mg/dL to <500 mg/dL, who were diagnosed with or at risk for atherosclerotic cardiovascular disease (ASCVD). A small percentage of participants (9%) had fasting triglycerides ≥500 mg/dL at baseline. Participants in the study received stable and optimized standard of care lipid-lowering therapies for at least four weeks prior to screening. Participants were randomized to receive 50 mg (n=276) or 80 mg (n=832) of olezarsen or placebo (n=369) every 4 weeks via subcutaneous injection for 12 months.

The primary endpoint was the percent change from baseline in fasting TG levels at six months compared to placebo. Key secondary endpoints included percent changes in triglyceride levels at 12 months, proportion of patients who achieve fasting TG<150 mg/dL and percent changes in other lipid parameters, including apoC-III, remnant cholesterol, non-HDL-C and apoB, compared to placebo over the treatment period.

About Hypertriglyceridemia

Triglycerides (TG) are a type of fat the body uses as a source of energy. While optimal levels for adults are typically below 150 mg/dL, levels higher than 150 mg/dL are a sign of hypertriglyceridemia. Levels higher than 500 mg/dL are a sign of a common condition called severe hypertriglyceridemia (sHTG), which puts millions of people at risk of potentially life-threatening acute pancreatitis (AP) and atherosclerotic cardiovascular disease (ASCVD) despite current standard of care. People with sHTG whose triglyceride levels are more than 880 mg/dL, including those with familial chylomicronemia syndrome (FCS), face a greater risk of AP.

About Olezarsen

Olezarsen is an investigational RNA-targeted medicine being evaluated for the treatment of sHTG. Olezarsen is designed to lower the body’s production of apoC-III, a protein produced in the liver that regulates triglyceride metabolism in the blood. The investigational medicine is currently being evaluated in two Phase 3 clinical trials – CORE and CORE2 – for the treatment of sHTG. Olezarsen has not been approved for the treatment of sHTG by regulatory authorities.

Olezarsen was recently approved in the U.S. as an adjunct to diet to reduce triglycerides in adults with FCS under the tradename TRYNGOLZA™ (olezarsen). For more information about TRYNGOLZA, visit TRYNGOLZA.com.

U.S. INDICATION for TRYNGOLZA™ (olezarsen)

TRYNGOLZA is an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to TRYNGOLZA or any of the excipients in TRYNGOLZA. Hypersensitivity reactions requiring medical treatment have occurred.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills and myalgias) have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur.

ADVERSE REACTIONS

The most common adverse reactions (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count and arthralgia.

Please see full Prescribing Information for TRYNGOLZA.

About Ionis Pharmaceuticals, Inc.

For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis currently has six marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. To learn more about Ionis, visit Ionis.com and follow us on X (Twitter), LinkedIn and Instagram.

Ionis Forward-looking Statements

This press release includes forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of our commercial medicines, olezarsen, additional medicines in development and technologies. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties including those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. Except as required by law, we undertake no obligation to update any forward-looking statements for any reason. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended December 31, 2024, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company.

In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our” and “us” all refer to Ionis Pharmaceuticals and its subsidiaries.

Ionis Pharmaceuticals^® and TRYNGOLZA™ are trademarks of Ionis Pharmaceuticals, Inc.

Contacts

Ionis Investor Contact:
D. Wade Walke, Ph.D.

IR@ionis.com 760-603-2331

Ionis Media Contact:
Hayley Soffer

media@ionis.com 760-603-4679

IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients with Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma




IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients with Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma

BASKING RIDGE, N.J. & RAHWAY, N.J.–(BUSINESS WIRE)–The first patient has been dosed in the IDeate-Esophageal01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing systemic therapy and an immune checkpoint inhibitor.

Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed with Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis for those diagnosed at an advanced stage of the disease.^1,2 While the evolved landscape in the first-line metastatic setting of ESCC has helped to improve outcomes for patients, treatment options are limited for patients progressing after first-line therapy, reinforcing the need for new approaches.

“Patients with metastatic esophageal squamous cell carcinoma continue to experience poor outcomes despite currently available treatments,” said Mark Rutstein, MD, Head, Therapeutic Area Oncology Development, Daiichi Sankyo. “The encouraging clinical activity seen in our early-phase signal finding trial supports further evaluation of ifinatamab deruxtecan as a potential treatment strategy for these patients.”

“Advanced esophageal squamous cell carcinoma is a difficult-to-treat disease, and unfortunately overall survival remains low,” said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “The initiation of the pivotal phase 3 IDeate-Esophageal01 clinical trial demonstrates our shared commitment with Daiichi Sankyo to further expand our clinical development program evaluating this potentially first-in-class ADC across multiple solid tumors where there are unmet needs for new treatment options.”

The initiation of IDeate-Esophageal01 is based on results from the IDeate-PanTumor01 phase 1/2 trial presented at both the 2022 and 2023 European Society of Medical Oncology (ESMO) where ifinatamab deruxtecan showed promising responses in heavily pretreated patients with ESCC.

About the IDeate-Esophageal01 Trial

IDeate-Esophageal01 is a global, multicenter, open-label, randomized phase 3 trial evaluating the safety and efficacy of ifinatamab deruxtecan (12 mg/kg) versus treatment of physician’s choice of chemotherapy (paclitaxel, docetaxel or irinotecan hydrochloride) in patients with advanced or metastatic ESCC with disease progression following treatment with platinum-based chemotherapy therapy and an immune checkpoint inhibitor. Eligible patients must have received no more than one prior line of systemic therapy in the advanced or metastatic setting.

The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival and objective response rate as assessed by blinded independent central review, and safety.

IDeate-Esophageal01 will enroll approximately 510 patients across Asia, Europe and North America. For more information, please visit ClinicalTrials.gov.

About Esophageal Squamous Cell Carcinoma

More than half a million esophageal cancer cases were diagnosed in 2022, with nearly half a million deaths globally.³ ESCC accounts for nearly 90% of esophageal cancers globally with a five-year overall survival rate around 15% to 20% and has a worse prognosis for those diagnosed at an advanced stage of the disease.^1,2 ESCC is most prevalent in Eastern Asia where mortality rates are also the highest.^1,2

While the evolved landscape in the first-line metastatic setting of ESCC has helped to improve outcomes for patients, treatment options are limited for patients progressing after first-line therapy, reinforcing the need for new approaches.

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins which bind to the CD28 family of receptors that includes PD-1.^4,5 B7-H3 is overexpressed in a wide range of cancer types, including ESCC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target.^6-9 There are currently no B7-H3 directed medicines approved for the treatment of any cancer.

About Ifinatamab Deruxtecan

Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

In addition to IDeate-Esophageal01, ifinatamab deruxtecan is being evaluated in a global development program that includes IDeate-Lung01, a phase 2 monotherapy trial in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC); IDeate-Lung02, a phase 3 trial in patients with relapsed SCLC versus investigator’s choice of chemotherapy; IDeate-Lung03, a phase 1b/2 trial in patients with ES-SCLC in combination with atezolizumab with or without carboplatin as first-line induction or maintenance therapy; IDeate-PanTumor02, a phase 2 monotherapy trial in patients with recurrent or metastatic solid tumors; and, IDeate-PanTumor01, a phase 1/2 first-in-human monotherapy trial in patients with advanced solid malignant tumors in collaboration with Sarah Cannon Research Institute (SCRI) with study operational oversight and delivery provided through SCRI’s early phase oncology clinical research organization, SCRI Development Innovations in Nashville, TN.

Ifinatamab deruxtecan has been granted orphan drug designation in the EU, Japan, Taiwan and US for the treatment of SCLC.

About the Daiichi Sankyo and Merck Collaboration

Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for gocatamig.

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU^®, a HER2 directed ADC, and DATROWAY^®, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform.

Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo

Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com.

Merck’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 Merck

At Merck, 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, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Global/US Media:
Jennifer Brennan

Daiichi Sankyo, Inc.

jennifer.brennan@daiichisankyo.com
+1 908 900 3183 (mobile)

Japan:
Daiichi Sankyo Co., Ltd.

DS-PR_jp@daiichisankyo.com

Investor Relations Contact:
DaiichiSankyoIR_jp@daiichisankyo.com

Merck
Media:
Julie Cunningham

(617) 519-6264

julie.cunningham@merck.com

Michael McArdle

(908) 447-9453

michael.mcardle@merck.com

Investors:
Peter Dannenbaum

(732) 594-1579

peter.dannenbaum@merck.com

Steven Graziano

(732) 594-1583

steven.graziano@merck.com