Peer-reviewed study demonstrates LEON’s FR-JET^® modular mixer enables stable high-concentration mRNA-LNPs with enhanced in vivo activity

Planegg/Munich (Germany), January 9^th, 2026 – A new study published in Pharmaceutics (https://doi.org/10.3390/pharmaceutics18010050) shows that LEON’s FR-JET^® modular mixer addresses key manufacturing challenges by enabling the production of highly concentrated lipid nanoparticles (LNPs). The study demonstrates that LNP formulation at significantly higher lipid mixture concentrations, beyond those currently reported in the literature and industry sources, can improve biological function in vivo, streamline manufacturing, and improve storage stability.

Overcoming the bottleneck

“There is growing recognition across the industry that LNP manufacturing challenges are not solely scientific, but are also largely operational in nature,” said Dr. Blerina Shkodra, lead author of the study. “Using LEON’s FR-JET^® technology, we show that LNPs can be formulated at lipid mixture concentrations above 50 mg/mL, not only retaining product quality but also enhancing potency in vivo. These findings indicate a practical approach to simplified manufacturing and increased throughput, enabling drug innovators to bring life-saving mRNA therapies to patients faster and more efficiently.”

Traditional microfluidic mixers are frequently limited by clogging, poor robustness, and scalability barriers, while conventional T-mixers can exhibit inconsistent reproducibility often associated with scaling-out strategies that can complicate manufacturing. In contrast, LEON’s FR-JET^® modular mixer delivers a robust mixing, unlocking process intensification while supporting a predictable and direct scale-up.
 

Why formulation at significantly higher lipid mixture concentrations matters for LNP developers:

Manufacturability – process intensification: Manufacturing at higher starting material concentrations can shorten, or even eliminate, the initial rate-limiting ultrafiltration step in tangential flow filtration (TFF), reducing overall downstream process time and buffer consumption during diafiltration.

Product Performance – potency and dosing: Cryogenic transmission electron microscopy (Cryo-TEM) revealed more uniform, solid-core particles. Increased lipid and RNA concentrations can enhance in vivo potency, which may translate into improved tolerability and more efficient dosing strategies.

Product Quality – morphology and stability: Higher solid-core fractions indicate more uniform particle morphologies, alongside demonstrated colloidal stability for 3 to 6 months in two different buffer systems.

CMC Scalability – development to manufacturing: This approach supports smoother translation from formulation development to manufacturing scale, enabling more robust processes and easier technology transfer.

“This peer-reviewed study validates the science behind the FR-JET^® technology and confirms that our commercially available manufacturing systems are making a big difference,” said Dr. Wolfgang Hofmann, CEO of LEON. “It marks the beginning of a new phase for LNP manufacturing, and it paves the way for what LEON has prepared to deliver in 2026.”

ABOUT LEON (leon-nanodrugs GmbH)

Based in Planegg/Munich, leon-nanodrugs GmbH is a Pharmatech company specializing in the development and commercialization of equipment for the encapsulation of genetic material and other pharmaceutical active substances into nanoparticles, such as lipid nanoparticles (LNPs). The company leverages its proprietary FR-JET^® technology to build innovative solutions. Its equipment portfolio includes NANOscreen^® for formulation screening, NANOlab^® for process development, as well as NANOme^® and NANOus^® for GMP manufacture. These systems are suitable for both individualized scales and commercial production, and the company further supports its clients by offering formulation and process development services. LEON’s platform aims to empower pharmaceutical companies, small biotech, research institutes, and CDMOs to capitalize on advancements in advanced therapies.

For further information, please visit https://leon-nanodrugs.com/ and follow us on LinkedIn.

During J. P. Morgan Healthcare Week, Biotech Showcase™ Provides Private and Micro- to Mid-Cap Public Company Executives One-Stop Access to Investors,
Pharma Partners and Media

Join Bristol Myers Squibb, Genentech, Google, J.P. Morgan, Novo Nordisk, Pappas Capital, Amazon Web Services, BIO, Members of the Media, and 1,200+ Investors

Registration and Partnering Platform Access Now Open

SAN FRANCISCO — January 9, 2026 — More than 3,000 leaders within biotechnology are registered to attend Biotech Showcase 2026 during J.P. Morgan Healthcare Week for unmatched opportunity to forge critical investment and partnering relationships as well as industry and financial media covering the event. Hosted by Demy-Colton and EBD Group, the event returns to the Hilton San Francisco Union Square January 12-14, 2026. A virtual event extends access to networking and insights January 20-21, 2026. Registration and partnering are now open for both.

Sara Jane Demy, Founder & CEO of Demy-Colton, said, “We anticipate renewed investment and dealmaking momentum in 2026, driven by rapid scientific advancement, evolving funding models, and the convergence of technology and biology. At the same time, policy changes are influencing how companies approach regulation, R&D strategy, capital deployment, and partnering. This is our 18th year for Biotech Showcase, and we’re so pleased it’s become a premier venue for dealmaking during JPM Week.”

Biotech Showcase attendees have the opportunity to:

• Engage in partnering and investment meetings among attending investors and pharma companies.
• Get to know emerging private and small-cap public biotech and TechBio companies through company presentations and partnering meetings.
• Meet with members of industry media including Endpoints, STAT, BioSpace, Fast Company, and others.
• Join curated discussions with leaders from companies like Novo Nordisk, Astellas, J.P. Morgan, Regeneron, Ipsen, Stifel, Sofinnova Investments, Cellino, Envisagenics, Syneos Health, and Angelini Ventures, among many others.

Tina Elder, Global Managing Director, EBD Group US, said, “As the premier investor conference for private and micro- to mid-cap biotechnology companies, Biotech Showcase offers unmatched opportunities for networking, dealmaking, and partnering across biotech, pharma, and the global investment community. As the industry looks toward 2026, Biotech Showcase provides a timely forum for engaging with the companies and leaders driving the industry’s evolution, offering direct exposure to emerging science, differentiated platforms, and the TechBio capabilities now essential to competitive drug development.”

Opening day highlights: 

Healthcare Innovation: Strategic Adaption to the New Policy Landscape

• Michael Margolis – Senior Managing Director, Head, Healthcare Investment Banking, Oppenheimer & Co. Inc.
• Thomas Barker – Partner, Co-Chair, Healthcare Department, Foley Hoag
• Fritz Bittenbender – Board Chair, BIO & SVP, Genentech
• Jeremy Levin – Chairman & CEO, Ovid Therapeutics Inc.
• Lori Reilly – COO, PhRMA
• Joe Shonkwiler – Head, Healthcare & Life Science, Venture Capital BD, Google

The 2026 Pharma Perspective: Dealmaking Driving Therapeutic Development

• David Schull – President, Russo Partners
• Tamara Darsow – SVP, Global Business Development, Novo Nordisk
• David Jenkins – SVP, Head, External Innovation and Research, Ipsen
• Amanda Kay – Senior Partner & Chief Business Development Officer, Flagship Pioneering
• Adam Pearson – Chief Strategy Officer, Astellas
• Konstantina Katcheves – SVP & Chief Business and Strategy Officer, Acadia Pharmaceuticals

New Breakthroughs in Drug Discovery & Target Identification

• Ignacio Guerrero-Ros – VP, Russo Partners
• Sean Lin – CEO, ChemLex
• Ravit Netzer – Co-Founder & CEO, Scala Biodesign
• Ritish Patnaik – CEO, Curve Biosciences
• Cameron Pye – Co-Founder & CEO, Unnatural Products Inc.
• Adrian Woolfson – Founder, President & CEO, Genyro

Closing day highlights:

Media Round-Up: Heard Around the Hilton

• Virginia Amann – CEO & Founder, ENTENTE Network
• Alex Philippidis – Senior Business Editor, GEN
• Allison DeAngelis – Reporter, Biotech Startups & Venture Capital, STAT News
• Ron Leuty – Senior Reporter, San Francisco Business Times
• Kyle LaHucik – Senior Reporter, Endpoints News
• Annalee Armstrong – Senior Editor, BioSpace

For information about registering for Biotech Showcase or to apply to present or sponsor, please visit www.informaconnect.com/biotech-showcase/. 

About Demy-Colton

Demy-Colton is a leading life sciences and digital health events organization at the forefront of building networks between innovative life sciences companies and industry stakeholders. Its unique events facilitate networking on a global scale, including Biotech Showcase™, BioFuture™, Global Biotech CEO Summit™, Executive Clinics™, and Demy-Colton Virtual Salons™. These events build networking communities that transcend geographical boundaries and establish ongoing, high-value relationships among the industry’s top decision-makers, investors and thought leaders. For more information, visit www.demy-colton.com. 

About Life Sciences Partnering and Investment by Informa

Our mission is to help collaborations get started across the life science value chain. Our range of partnering conferences has grown to become the largest and most productive conference platform in the industry. Each one of our landmark events held in key life science markets around the world is powered by our state-of-the-art partnering software, partneringONE®, that enables delegates to efficiently identify and engage with new opportunities via one-to-one meetings. Today, our events (BIO-Europe®, BIO-Europe Spring®, Biotech Showcase™, ChinaBio® Partnering Forum, Asia Bio Partnering Forum, BioEquity Europe, LSX USA Congress, Investival Showcase Europe, European Lifestars Awards, Investival Showcase USA, LSX Europe Congress, LSX Nordic Congress) annually attract more than 14,000 senior life science executives who engage in over 83,000 one-to-one partnering meetings. These vital one-to-one engagements are the wellspring of deals that drive innovation in our industry.

Contact
Katie Morris
ENTENTE Network of Companies
katiemorris@ententeinc.com

MC Services, Inc.
Laurie Doyle
Phone: +1-339-832-0752
E-mail: EBDGroup@mc-services.eu

Bad Homburg, January 9, 2026 – Fresenius Medical Care AG (“Company”) has decided to continue the share buyback program announced in an ad-hoc release on June 17, 2025, by repurchasing a second tranche. The share buyback program has a total volume of EUR 1 billion (excluding ancillary costs).

The first tranche of the Company’s share buyback program was completed ahead of schedule on December 29, 2025.

With the second tranche it is intended to repurchase own shares for a total amount of around EUR 415 million from January 12, 2026, to May 8, 2026 (inclusive). The share buyback program is therefore expected to be completed significantly earlier. The shares shall be acquired on the stock exchange and are to be predominantly redeemed and, to a significantly lesser extent, may be used for allocations under incentive-based compensation plans.

The share buyback program is based on the authorization to purchase and use treasury shares granted by the Company’s Annual General Meeting on May 20, 2021.

Contact:
Dr. Dominik K. Heger
Executive Vice President
Global Head of Investor Relations, Market & Competition, Sustainability
& Head of Investor Relations

Fresenius Medical Care AG
Else-Kroener-Strasse 1, 61352 Bad Homburg v.d. Hoehe, Germany
P +49 6172 2685822
Dominik.Heger@FreseniusMedicalCare.com
www.FreseniusMedicalCare.com

VarmX and Rentschler Biopharma partner to advance novel coagulation therapy toward Phase 3 and commercialization

• VarmX and Rentschler Biopharma expand collaboration from early development to late‑stage and commercial manufacturing of VMX-C001
• VMX‑C001 builds on strong regulatory momentum, including FDA Fast Track Designation and PMDA Phase 1 waiver, as it progresses toward a global Phase 3 trial
• Manufacturing will be transferred from Rentschler Biopharma site in Laupheim (Germany) to Milford, MA (USA)

Laupheim, Germany; Leiden, The Netherlands and Milford, MA USA. January 8, 2026 – Rentschler Biopharma, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, and VarmX, a biotech company developing innovative approaches for the bypass of direct oral anticoagulants targeting activated factor Xa (FXa DOACs) and treatment of inherited coagulation disorders, today announced a collaboration to manufacture VarmX’s lead program, VMX-C001, for Phase 3 development and potential commercialization. VMX-C001 is a novel treatment to restore blood coagulation in patients requiring urgent surgery or experiencing severe bleeding while on FXa DOACs.

Rentschler Biopharma began supporting early development of VMX-C001 in 2022 at its Laupheim, Germany site and VarmX has since initiated its Phase 3 program using GMP material from Rentschler Biopharma. Building on the successful collaboration between both companies, all subsequent Phase 3 clinical supply, including process validation, will be manufactured at Rentschler Biopharma’s Milford, MA site as part of the seamless transition into late-stage clinical and commercial production. The CDMO brings strong expertise in producing a variety of biologics, including proven capabilities in intensified, perfusion-based processes, while also supporting fed-batch strategies. Rentschler Biopharma provides clients with continuity, speed and reliability from early development through commercialization and beyond.

VMX-C001 is a modified, human factor X protein, designed to be insensitive to FXa DOACs, effectively bypassing their anticoagulant activity and swiftly restoring the coagulation cascade. The product candidate was granted Fast Track Designation by the U.S. Food & Drug Administration (FDA) and a Phase 1 waiver from Japanese regulator PMDA in September 2025, recognizing the unmet need for treatments that can rapidly restore coagulation in patients receiving FXa DOACs. VarmX signed a global strategic collaboration and option agreement with CSL in September 2025. VarmX plans to initiate its global Phase 3 EquilibriX-S trial in urgent surgery in early 2026.

John Glasspool, Chief Executive Officer of VarmX, said: “Manufacturing readiness is key as we prepare to commence our landmark global EquilibriX-S Phase 3 trial, evaluating the ability of VMX-C001 to rapidly restore coagulation in patients taking any FXa DOAC undergoing urgent surgery. We’re pleased to extend our partnership with Rentschler Biopharma as we drive VMX-C001 towards becoming a new treatment option for the substantial number of patients on FXa DOACs who need emergency surgery.”

Benedikt von Braunmühl, Chief Executive Officer of Rentschler Biopharma, commented: “We are honored to continue our collaboration with VarmX, which reflects exactly what Rentschler Biopharma stands for: high‑impact technical expertise, long‑term partnership grounded in trust, and tailored solutions that bring breakthrough therapies to patients. As VMX‑C001 advances toward Phase 3, we remain fully committed to delivering seamless continuity, leveraging our FDA‑licensed sites in the EU and the U.S. and deep experience in late‑stage development and market approval. Guided by our vision of advancing medicine to save lives – together, we look forward to supporting VarmX on the path to commercialization.”

By 2030, approximately 30 million patients in the U.S., Europe and Japan are expected to receive FXa DOACs as a chronic anticoagulation therapy, including stroke prevention in atrial fibrillation and the prevention of deep vein thrombosis. Each week, more than 30,000 of these patients experience severe life-threatening bleeding or require emergency surgery, where the risk of bleeding poses a critical challenge¹.

VMX-C001 has been developed with significant clinical advantages, including universal dosing regardless of the specific FXa DOAC used, rapid and easy administration, compatibility with common anticoagulants like heparin, and no additional thrombotic risk. This strengthens the position of VMX-C001 to potentially become a new option for the substantial number of patients on FXa DOACs who need emergency surgery.

1: RBC and Cowen (2018–2024), Syneos Health Consulting (incl. Japan), and clinical literature

About Rentschler Biopharma SE

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability. For further information about the company, please visit www.rentschler-biopharma.com. Follow Rentschler Biopharma on LinkedIn.

About VarmX

VarmX is a spin-off from the Leiden University Medical Center (LUMC), founded in 2016 by Professor Pieter Reitsma, a world leading expert in hemostasis and thrombosis. VarmX’s lead compound VMX-C001 is a modified recombinant blood factor X. The compound is being developed for the treatment of severe spontaneous bleeding and for the prevention of bleeding during urgent surgery in patients taking oral factor Xa inhibitors (FXa DOACs) as anticoagulation therapy. The Company is supported by a strong syndicate of investors including Sound Bioventures, EIC, EQT Life Sciences (formerly LSP), Inkef, Lundbeckfonden BioCapital, Ysios Capital, BioGeneration Ventures and InnovationQuarter, as well as CSL. For more information, please visit www.varmx.com.

Contact:

Rentschler Biopharma SE
Dr. Latika Bhonsle-Deeng
Global Head of Communications
Phone: +49-7392-701-467
communications@rentschler-biopharma.com

Media inquiries

VarmX Media inquiries
Vigo Consulting
Rozi Morris
Phone: +44 20 7390 0230
VarmX@vigoconsulting.com

Hamburg, Germany, January 08, 2026:
Evotec SE (NASDAQ: EVO; Frankfurt Prime Standard: EVT) today announces that its Seattle-based subsidiary, Just – Evotec Biologics, Inc., has received a new grant from the Gates Foundation to enable global access to biotherapeutics utilizing Just – Evotec Biologics’ molecular design suite of computational technologies, called “J.MD™”.

Investment (INV072135) continues the support for selected Gates Foundation grantees to improve the developability and reduce the cost of goods of monoclonal antibodies to make them more affordable and accessible and prevent infectious disease in low- and middle-income countries.

Under the grant terms, Just – Evotec Biologics will leverage its J.MD™ Molecular Design service – a key component of its J.DESIGN™ platform, that integrates advanced computational tools and high-throughput methodologies to streamline the biologics development process. By optimizing molecular design from the earliest stages, J.MD™ ensures manufacturability, stability, and efficacy—critical factors for reducing costs and enabling expansion of global access to these therapies as well as limiting liabilities like immunogenicity and instability. The new investment will enable ten (10) new J.MD™ projects over the next three years, spanning the development of biotherapeutics targeting multiple global health disease indications of concern.

This grant extends the commitment of Just – Evotec Biologics, that began in 2014 and has since delivered multiple cGMP manufacturing campaigns for RSV, Malaria, and HIV monoclonal antibodies.

Dr. Linda Zuckerman, EVP and Global Head of Just – Evotec Biologics, commented: “We are thrilled to receive this new grant from the Gates Foundation which will strengthen our commitment to reducing the cost of biologics development to expand global access. By leveraging our J.DESIGN™ platform and innovative molecular design tools, we look forward to supporting the foundation in driving impactful solutions across multiple disease areas and continuing to deliver therapies where they are needed most.”

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, added: “We are proud to continue our collaboration with the foundation through this new grant which enables us to harness Just – Evotec Biologics’ advanced platforms and scientific expertise to support the broader research ecosystem. This partnership strengthens our shared mission to accelerate the development of biotherapeutics that address urgent and unmet medical needs.”

For expert insights about the importance of thoughtful antibody design driving global access, watch our virtual roundtable, Antibody Design to Support Global Health Initiatives, featuring key voices from the Gates Foundation and global health researchers.

About Just – Evotec Biologics
Just – Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform company that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch. The Just – Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics. Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners. Learn more at www.just-evotecbiologics.com.

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

PRESS RELEASE

Viromed AG: Strategic Update on Operational Focus and Value Creation

Rellingen, January 7, 2026 – Viromed Medical AG (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer in cold plasma technology, today provides a strategic update on its operational orientation. The focus of the Company’s entrepreneurial activities remains unchanged and is centered on sustainable, technology-driven growth in the international MedTech market. In this context, Viromed concentrates on the development of innovative medical devices as well as on translational research in the field of severe respiratory diseases — in particular ventilator-associated pneumonia (VAP).

Over the past two years, Viromed has developed two novel cold plasma medical devices:

• ViroCAP® — an innovative cold plasma device for medical wound healing
• PulmoPlas® — a globally unique cold plasma system for applications in pneumology and respiratory tract infections

Particular importance is attributed to the next-generation technological platform — PulmoPlas®. This unique cold plasma system forms the basis for future scaling potential across multiple medical indication areas.

In the research domain, Viromed has established a high-performance scientific consortium consisting of Hannover Medical School (MHH), the Helmholtz Centre for Infection Research (HZI) in Braunschweig, and the Leibniz Institute in Jena. This network brings together international top-level expertise in infectiology, pneumology, and translational research and enables the development of novel therapeutic approaches for diseases of the upper and lower respiratory tract.

The comprehensive publication of the results by MHH and HZI is expected at the end of January 2026.

For further technological development, Viromed works closely with Relyon Plasma, a subsidiary of TDK. In addition, international partnerships in Europe, Korea, and Turkey have been established, supporting future market entry and underscoring the global relevance of the technology.

As a result of the strategic focus on research, development, and the establishment of international market structures, longer innovation cycles naturally arise. Viromed therefore deliberately refrains from communicating short-term operational interim updates. Communication with various stakeholders follows the principle of reporting substantial and relevant milestones — in the interest of long-term, sustainable corporate development.

Viromed Medical AG’s corporate strategy is geared toward long-term value generation. Against this backdrop, the Company’s research and development programs are consistently aligned with medical benefit, clinical relevance, and sustainable market potential.

Viromed is recognized as a pioneer in pneumological research and plasma technology. The innovation work of the Company’s scientific network has the potential to significantly shape future therapeutic approaches for severe respiratory infections. According to its own assessment, Viromed will play a significant role in the global fight against pathogenic germs in the coming years — particularly with PulmoPlas®.

In addition, Viromed has successfully overcome the new, stringent regulatory hurdles for the approval of ViroCAP® over the past 18 months. Market acceptance and demand for ViroCAP® are already very high.

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de

Immunic Highlights 2025 Accomplishments and Upcoming Milestones

– Completed Enrollment for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected by End of 2026 –

– Phase 2 CALLIPER Data Showed Vidofludimus Calcium Reduced 24-Week Confirmed Disability Worsening and Increased 24-Week Confirmed Disability Improvement Across Progressive Multiple Sclerosis and Its Subtypes, Reinforcing the Drug’s Direct Neuroprotective Mechanism of Action –

 – Long-Term Open-Label Data from Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis Showed Low Rates of Confirmed Disability Worsening Events and Favorable Long-Term Safety and Tolerability –

 – U.S. Patent Allowed for Dose Strengths of Vidofludimus Calcium in Progressive Multiple Sclerosis, Strengthening Intellectual Property Protection Into 2041 –

NEW YORK, January 7, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today highlighted its 2025 accomplishments and upcoming milestones.

“The past year has been transformational for our lead asset vidofludimus calcium (IMU-838),” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We are pleased to have completed enrollment in our twin phase 3 ENSURE-1 and ENSURE-2 trials of vidofludimus calcium in relapsing multiple sclerosis (RMS) and are deeply grateful to the Immunic team, our clinical investigators, site teams, and especially the participants for making this milestone possible. We now eagerly anticipate the synchronized top-line data readout by the end of 2026. The scale, quality, and geographic breadth of the ENSURE trials give us exceptional confidence that the results will provide a clear and comprehensive picture of vidofludimus calcium’s potential to reshape the RMS treatment paradigm. Additionally, long-term open-label extension (OLE) data from the phase 2 EMPhASIS trial in relapsing-remitting multiple sclerosis (RRMS) showed that a substantial majority of patients remained free of confirmed disability worsening (CDW) over extended follow-ups, underscoring vidofludimus calcium’s potential to meaningfully slow disease progression, giving patients greater independence and a lower burden in managing symptoms over the long term.”

Jason Tardio, President and Chief Operating Officer of Immunic, added, “The ENSURE program represents more than a pivotal clinical milestone—it reflects an opportunity to advance how disease modification in RMS is approached. Today’s oral RMS treatment landscape is largely defined by therapies with complex risk-benefit profiles that primarily target inflammation and relapses, while often falling short of adequately addressing the neurodegeneration that drives long-term disability. With a dual mechanism of action, vidofludimus calcium is designed to provide direct neuroprotection by enhancing neuronal survival and function through Nurr1 activation, as well as limiting new inflammatory injury through selective DHODH inhibition. Together with its favorable safety and tolerability profile to date, we believe vidofludimus calcium has the potential to offer the most compelling benefit-risk profile among oral disease-modifying therapies for RMS.”

“Equally important are the strong signals we continue to see in progressive multiple sclerosis (PMS) from our phase 2 CALLIPER trial,” continued Dr. Vitt. “In particular, the data has demonstrated clinically meaningful reductions in 24-week CDW (24wCDW) across the overall PMS population, supported by consistent trends across PMS subtypes and subpopulations. Notably, there was no dependency of the 24wCDW effect size on the presence of markers of inflammatory disease at baseline, such as gadolinium-enhancing lesions, supporting our hypothesis of clinical neuroprotective effects independent of anti-inflammatory effects. The positive 24-week confirmed disability improvement (24wCDI) results were statistically significant in the overall PMS population, with consistent trends across subtypes. The findings from our CALLIPER trial reinforce vidofludimus calcium’s unique mechanism of action targeting neurodegeneration and help de-risk potential late-stage development in PMS.”

Dr. Vitt concluded, “As we execute our MS strategy with vidofludimus calcium, we also remain committed to advancing IMU-856, our orally available and systemically acting small molecule modulator that targets Sirtuin 6 (SIRT6), as our next pipeline innovation. IMU-856’s potential ability to restore intestinal barrier function and regenerate bowel epithelium has generated compelling early clinical signals in celiac disease patients, supporting potential development in various gastrointestinal disorders. Additionally, we have seen encouraging preclinical and early clinical effects that may indicate the potential for IMU-856 as an oral treatment option for weight management.”

Vidofludimus Calcium 2025 Highlights and Upcoming Milestones

• Completed enrollment for both phase 3 ENSURE trials of vidofludimus calcium in patients with RMS. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 were randomized at more than 100 sites in 15 countries. Top-line data is expected by the end of 2026.
• Announced positive phase 2 CALLIPER data in PMS, highlighting vidofludimus calcium’s neuroprotective potential across PMS as well as PMS subpopulations and subtypes. The data, showing consistent 24wCDW results across patient groups, including those without evidence of baseline inflammatory gadolinium-enhancing (Gd+) lesions, were seen in the overall population and in the key primary progressive multiple sclerosis (PPMS) and non-active secondary progressive multiple sclerosis (naSPMS) subgroups. 24wCDI data demonstrated more than a two-fold probability of clinical improvement versus placebo, achieving statistical significance in the overall PMS population with consistent trends across subtypes. Vidofludimus calcium also lowered thalamic atrophy and new or enlarging T2 lesion volume versus placebo. No new safety signals were observed and vidofludimus calcium continued to show a favorable safety and tolerability profile. Given that 24wCDW is an accepted regulatory endpoint in PMS, these results strengthen the evidence of clinical activity and should help to de-risk a potential phase 3 program.
• Reported new, positive long-term OLE data from the phase 2 EMPhASIS trial of vidofludimus calcium in patients with RRMS. At week 144, 92.3% of patients remained free of 12wCDW with 92.7% remaining free of 24wCDW. Vidofludimus calcium continued to demonstrate a favorable safety and tolerability profile with long-term data available up to 5.5 years.
• Received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering dose strengths of vidofludimus calcium for the treatment of PMS, including PPMS and SPMS. The company’s multilayered intellectual property strategy now provides protection into 2041 in the United States, unless extended further.
• Presented key data highlighting vidofludimus calcium’s therapeutic potential in MS at various scientific and medical conferences, including the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), the 17th International Congress of the International Society of Neuroimmunology (ISNI), the 11th Congress of the European Academy of Neurology (EAN) – Helsinki 2025, the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting 2025, the American Academy of Neurology (AAN) 2025 Annual Meeting and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025. The results from the phase 2 CALLIPER trial in PMS were also selected for the Best of ECTRIMS 2025 slide deck.

IMU-856 2025 Highlights and Upcoming Milestones

• Announced that IMU-856 demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of patients from the phase 1b clinical trial in celiac disease. IMU-856 also showed a dose-dependent reduction of body weight gain and food consumption in preclinical in vivo testing. These effects may indicate the potential for IMU-856 as an oral treatment option for weight management.
• Presented further analyses from the phase 1/1b clinical trial of IMU-856 in healthy subjects and celiac disease patients at several key gastroenterology conferences, including at UEGW 2025 – United European Gastroenterology Week, Digestive Disease Week (DDW) and the 19th Congress of ECCO (European Crohn’s and Colitis Organisation).
• The company continues preparing for further clinical testing of IMU-856, contingent on financing, licensing or partnering.

2025 Corporate Highlights

• Closed a $5.1 million registered direct offering led by Aberdeen Investments.
• Closed an oversubscribed $65 million underwritten public offering, co-led by BVF Partners and Coastlands Capital, and including participation from Aberdeen Investments, Adage Capital Partners LP, Janus Henderson Investors, and other institutional investors.

Immunic’s management, business development and investor relations teams will be hosting one-on-one meetings in connection with the 44th Annual J.P. Morgan Healthcare Conference taking place January 12-15, 2026, in San Francisco. To schedule a meeting, please contact Jessica Breu at: jessica.breu@imux.com.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for Immunic’s development programs to safely and effectively target diseases; preclinical and clinical data for Immunic’s development programs; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; the executive and board structure of the company; and the company’s expected cash runway. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information 

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com 

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com

Newron Pharmaceuticals S.p.A.: EA Pharma, a subsidiary of Eisai, Announces the Initiation of its Phase III Clinical Trial with Evenamide, a Novel Treatment for Schizophrenia, in Japan

Milan, Italy, and Morristown, NJ, USA, January 7, 2026 – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, is pleased to note that its partner EA Pharma Co., Ltd. (EAP), has  announced today the initiation of its Phase III clinical trial with evenamide, a novel excessive glutamate release modulator, in Japan.

Stefan Weber, CEO of Newron Pharmaceuticals, commented: “The initiation of EA Pharma’s Phase III study of evenamide in Japan represents an important step in the global development of the program. This milestone, together with Newron’s ongoing global (excluding EAP territories) ENIGMA-TRS Phase III studies reflects continued progress and momentum for evenamide and further supports its potential as a differentiated add-on therapy in schizophrenia.”

The full text of the announcement from EAP is as follows:

EA Pharma Announces Initiation of Phase III Clinical Trial of EA8001, a Novel Treatment for Schizophrenia, in Japan

EA Pharma Co., Ltd. (Head Office, Chuo-ku, Tokyo, Japan; President, Hidenori Yabune; “EA Pharma”) announced today that Phase III clinical trial of EA8001 (non -proprietary name: evenamide), a novel excessive glutamate release modulator, is now ready to begin in Japan (hereinafter the “Trial”).  

EA Pharma initiates the Trial after review by the institutional review board of the clinical site and other related procedures. This Trial is a multicenter randomized double-blind placebo-controlled clinical trial in patients with treatment-resistant schizophrenia who show poor or inadequate response to at least two different types of antipsychotics, evaluating the efficacy, safety and tolerability of EA8001 as an add-on treatment. EA Pharma is striving to quickly contribute to addressing the needs of, and increasing the benefits provided to, patients with schizophrenia, their families and healthcare providers.

Inquiries

EA Pharma Co., Ltd.
Corporate Communication Dept. Mail: contact_ea@ eapharma.co.jp

《More Information》

1. About schizophrenia

Schizophrenia, which approximately 1% of the Japanese population is affected by, consists of positive symptoms (such as hallucinations and delusions), negative symptoms (such as reduced emotions and avolition), and cognitive impairment (such as memory and decision-making difficulties), and those symptoms may cause difficulty in everyday life and social activities [1]. Current antipsychotics mainly function through the dopamine and/or serotonin pathways, and those antipsychotics are known to show side effects (such as extrapyramidal symptoms, weight gain, and prolactin elevation). Among those patients treated with current antipsychotics, a considerable number of patients become treatment-resistant or poor responsive. Therefore, there is a demand for a drug which can address all those points.

2. About evenamide

Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial [2], as an add-on treatment to second generation anti-psychotics, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS) [3], and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increase in proportion of patients who experienced “clinically meaningful benefit*” on the outcome variables[4]. 

*Against placebo in the two categories: at least 20% improvement in PANSS, and Score 2 or below in Clinical Global Impression Scale – Corrections (CGI-C)

3. About Alliance between EA Pharma and Newron Pharmaceuticals S.p.A.

EA Pharma obtained the right to develop, manufacture and commercialize evenamide in Japan and other key Asian territories [5] under the license agreement with Newron Pharmaceuticals S.p.A. as of December 2024. 

For more details, please see https://www.eapharma.co.jp/en/investors/news/2024/1213.

4. About EA Pharma Co., Ltd.

EA Pharma Co., Ltd. is a subsidiary of Eisai Co., Ltd. It was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year’s history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing. 

For further information on EA Pharma Co., Ltd., please visit   https://www.eapharma.co.jp/en/

[1] National Center of Neurology and Psychiatry （https://www.ncnp.go.jp/en/）

[2] A “pivotal phase III trial” is a key clinical trial to collect definitive evidence of efficacy and safety in primary endpoints that can support a regulatory approval. Usually, data collected from multiple confirmatory trials (pivotal trials) are required for a regulatory approval in many countries. 

[3] Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)

[4] Efficacy and safety of evenamide, a glutamate modulator, added to a second-generation antipsychotic in inadequately/poorly responding patients with chronic schizophrenia: Results from a randomized, double-blind, placebo-controlled, phase 3, international clinical trial. (Neuropharmacology. 2025: https://pubmed.ncbi.nlm.nih.gov/39708914/)

[5] Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: www.newron.com

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com 

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Pentixapharm Receives FDA Feedback for Phase 3 Diagnostic Study in Hypertension

• Formal written minutes from the U.S. FDA confirms no major concerns identified for the planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor in treatment-resistant hypertension and Primary Aldosteronism

• Type B pre-IND meeting provided non-binding guidance on key statistical and methodological aspects, enabling refinement of the Phase 3 study design

• Feedback clarifies evidence requirements relevant to a potential approval pathway, supporting the planned IND submission for the company’s leading CXCR4-directed flagship program

Berlin, Germany, January 07, 2026 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced that it has received the formal written minutes from its recent scientific advice meeting with the U.S. Food and Drug Administration (FDA) for the planned Phase 3 PANDA study of [⁶⁸Ga]Ga-PentixaFor, the company’s leading CXCR4-directed flagship program. The PANDA study will evaluate the radiodiagnostic as a potential new tool to improve the diagnostic pathway for patients with treatment-resistant hypertension and primary aldosteronism (PA). By enabling disease subtyping, PET/CT imaging with [⁶⁸Ga]Ga-PentixaFor has the potential to better guide the most appropriate therapy, supporting more precise and effective treatment decisions.

The FDA’s minutes provide further clarification on several important statistical,  methodological aspects, and criteria for assessing diagnostic performance of the planned Phase 3 study and expand on the preliminary feedback from the meeting,  previously communicated on December 3, 2025.

“The FDA’s formal written feedback provides important clarity on key design and analysis elements of our planned Phase 3 PANDA study with [⁶⁸Ga]Ga-PentixaFor and confirms that no major concerns have been identified,” said Dr. Dirk Pleimes, CEO and CMO of Pentixapharm. “Importantly, the feedback also provides guidance on the evidence requirements toward potential approval, including the role of confirmatory evidence in combination with this single Phase 3 study. This guidance strengthens our preparations for the planned IND submission and further supports the development of a potentially scalable, non-invasive diagnostic tool for patients with primary aldosteronism – the most common cause of secondary hypertension and a condition that remains significantly underdiagnosed.”
 

 About [^⁶⁸Ga]Ga-PentixaForin treatment-resistant hypertension and primary aldosteronism

[⁶⁸Ga]Ga-PentixaFor is a novel, potentially first-in-class gallium-68-labeled radiodiagnostic designed to selectively target the chemokine receptor CXCR4 and to visualize its expression using high-resolution PET/CT imaging. Clinical experience with [⁶⁸Ga]Ga-PentixaFor PET/CT is documented in more than 100 scientific publications encompassing over 2,600 patients across multiple indications, including more than 1,600 patients with primary aldosteronism. In published and ongoing studies, the diagnostic has demonstrated reproducible in vivo imaging of CXCR4 expression with a favorable safety profile.

Recent research has shown strong CXCR4 overexpression in aldosterone-producing adrenal tumors, a hallmark of unilateral primary aldosteronism. Primary aldosteronism is a common but historically underdiagnosed cause of secondary hypertension, largely because reliably distinguishing unilateral from bilateral disease remains challenging with current diagnostic tools. Unilateral disease is typically treated by surgical removal of the affected adrenal gland whereas bilateral disease requires life-long medical therapy. By visualizing CXCR4 expression in aldosterone-producing tissue, [⁶⁸Ga]Ga-PentixaFor has the potential to support more reliable subtyping of primary aldosteronism and thereby better guide appropriate treatment decisions.
 

 About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops precision diagnostics and therapeutics in oncology and cardiology to transform patient care. Its clinical pipeline is anchored by CXCR4-targeted PET-CT programs, including a Phase 3-ready candidate for the improved diagnosis of hypertensive patients with primary aldosteronism, which is intended to enable targeted treatment of the underlying causes of hypertension. CXCR4-based developments also include pioneering therapeutic programs in hematological cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-checkpoint marker over-expressed in multiple hard-to-treat cancers. Complemented by CXCR4 and CD24 intellectual property protection and a reliable isotope supply chain, Pentixapharm is poised to deliver meaningful patient benefit and sustainable growth in one of the fastest-growing areas of precision medicine.

Pentixapharm Investor and Media Contact

ir@pentixapharm.com