4Moving Biotech Announces the Closing of a €12 Million Financing to Advance a First-in-Class DMOAD in Knee Osteoarthritis




4Moving Biotech Announces the Closing of a €12 Million Financing to Advance a First-in-Class DMOAD in Knee Osteoarthritis

– Funding secured, extending the financial runway to reach a proof-of-concept inflection point

– Company’s attractiveness reinforced through the onboarding of new investors

LILLE, France & PARIS–(BUSINESS WIRE)–4Moving Biotech (4MB), a clinical-stage biotechnology company and a spin-off of 4P-Pharma, developing a first-in-class disease-modifying osteoarthritis drug (DMOAD) for knee osteoarthritis, today announced the closing of a €12 million financing, completed through a structured and coordinated funding process.

This financing was secured from a pool of private investors and family offices, who chose to reinforce their commitment by investing directly at the subsidiary level in 4MB. The round includes a combination of equity and loans, reflecting a flexible capital structure aligned with long-term value creation.

This closing forms a natural continuum following the €7.6 million France 2030 i-Démo grant announced last year, and the very recent transatlantic extension of the INFLAM-MOTION Phase 2a clinical study to the US, reinforcing 4MB’s runway to execute its lead DMOAD program addressing a major unmet medical need in knee osteoarthritis.

“With this closing in place, we are well equipped to reach the next value creation milestone by delivering robust Phase 2a data, reaching a proof-of-concept inflection point, and creating strategic optionality for subsequent stages of development to address the needs of the 374 million patients suffering from osteoarthritis worldwide,” said Luc Boblet, CEO of 4MB.

Founded in 2020, 4MB has now received approximately €30 million in total funding to date, combining private financing and non-dilutive public support. This trajectory illustrates a strong long-term strategy led by 4P-Pharma and built on its proprietary drug regeneration model, addressing untreated serious diseases and implemented independently by each of its subsidiaries.

“The arrival of new investors in 4MB reflects the strength and coherence of the 4P-Pharma group’s platform, built on disciplined capital allocation and scientific rigor,” added Revital Rattenbach, CEO of 4P-Pharma and co-founder of 4MB. “By enabling our subsidiaries to independently define and execute their own trajectories, 4P-Pharma demonstrates the relevance of its start-up studio model.”

In the coming months, 4MB will focus on executing its clinical strategy in preparation for future regulatory agency interactions and on facilitating patient access to its molecule for those who need it most.

About 4Moving Biotech

Founded in 2020 as a spin-off of 4P-Pharma, 4Moving Biotech is a clinical-stage biotechnology company developing disease-modifying drugs for osteoarthritis, one of the world’s most burdensome chronic diseases, affecting more than 600 million people and lacking approved therapies that alter disease course. Headquartered on the Pasteur Institute campus in Lille, 4MB aims to deliver safe, sustainable therapeutic solutions for patients with high unmet medical needs.

Website: www.4movingbiotech.com
LinkedIn: https://www.linkedin.com/company/4moving-biotech/?viewAsMember=true
X : https://x.com/4Moving_Biotech

Contacts

Press
Emmanuel Dadjé

Communication Manager

Email : Emmanuel.dadje@4P-pharma.com
Phone : +33 6 30 06 12 13

ZCG-Backed Unimed Acquires Regenboog Shipping Pharmacy




ZCG-Backed Unimed Acquires Regenboog Shipping Pharmacy

Acquisition Expands Unimed’s Netherlands Footprint and Builds on Lagaay Integration

NEW YORK–(BUSINESS WIRE)–Universal Maritime Solutions (“Unimed” or “the Company”), a leading global provider of medical and compliance solutions to the maritime industry, today announced the acquisition of Regenboog Shipping Pharmacy, a Netherlands-based distributor of pharmaceutical products and medical devices serving the maritime sector. Unimed is backed by ZCG Private Equity, the private equity arm of Z Capital Group, LLC (“ZCG”), a privately held global firm.

Based in Rotterdam, Regenboog Shipping Pharmacy has been a trusted partner to the maritime industry since 1989, providing a broad portfolio of pharmaceutical products and medical devices across more than 1,000 SKUs. The business serves more than 300 customers, including ship managers, ship chandlers, and individual vessels operating globally.

“This acquisition represents an important step in our growth strategy, strengthens Unimed’s presence in the Netherlands and builds on the Company’s recent acquisition of Lagaay Medical Group, further expanding Unimed’s scale and capabilities in a core European market. The business brings a strong local presence, deep customer relationships, and a proven operating model. We are pleased to welcome the team to the group and look forward to supporting their continued success while maintaining the high standards of service their customers rely on,” said Adam Pang, Chief Revenue Officer of Unimed.

The transaction reflects Unimed’s broader strategy under ZCG ownership to pursue targeted, locally focused acquisitions that enhance regional coverage and access to operational resources while supporting long-term platform development.

“Unimed’s continued expansion in the Netherlands reflects our long-term approach to building market-leading platforms through disciplined, strategic acquisitions,” said James J. Zenni, Founder, President, and Chief Executive Officer of ZCG. “By investing in businesses with deep local roots and strong customer relationships, we are reinforcing Unimed’s regional leadership and supporting its ability to deliver comprehensive solutions to the global maritime industry.”

About Unimed

Unimed is a leading global provider of medical and compliance solutions to the maritime industry, specializing in the delivery of integrated medical equipment and supplies, healthcare services, and safety supply chain logistical solutions to clients worldwide.

Unimed is a portfolio company of ZCG Private Equity, the private equity arm of ZCG (www.zcg.com), a leading privately held global firm.

For more information, please visit https://universalmarinemedical.com/.

About ZCG

ZCG is a leading, privately held global firm comprised of private markets asset management, business consulting services, and technology development and solutions.

ZCG’s investors are some of the largest and most sophisticated global institutional investors including pension funds, endowments, foundations, sovereign wealth funds, central banks, and insurance companies.

For almost 30 years, ZCG Principals have invested tens of billions of dollars of capital. ZCG has a global team comprised of approximately 400 professionals. ZCG is headquartered in New York, with seven affiliated offices, across five countries. For more information on ZCG, please visit www.zcg.com.

You can also learn more about ZCGC, the business consulting services platform of ZCG, at www.zcgc.com, and explore ZCG’s technology affiliate, Haptiq, at www.haptiq.com.

Contacts

Nina Zenni

ZCG / Principal, Head of Media & Global Communications

Tel. 212-595-8400

Direct. 646-787-2365

Ethris and German Center for Infection Research (DZIF) Announce Strategic Collaboration to Develop mRNA-Based Vaccines




Ethris and German Center for Infection Research (DZIF) Announce Strategic Collaboration to Develop mRNA-Based Vaccines

• Collaboration combines Ethris’ proprietary technology platforms with DZIF’s infectious disease research expertise to advance mRNA-based vaccines across a broad range of pathogens
• Agreement enables manufacturing of mRNA vaccine material by Ethris’ partners Patheon and Evonik for DZIF-led vaccine research & development

MUNICH–(BUSINESS WIRE)–Ethris GmbH, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics and vaccines, and the German Center for Infection Research (Deutsches Zentrum für Infektionsforschung, DZIF), today announced a strategic research collaboration to develop mRNA-based vaccines for the prevention and treatment of infectious diseases. The collaboration combines Ethris’ proprietary, clinically-validated mRNA technology platforms with DZIF’s translational vaccine research expertise spanning a broad spectrum of pathogens, including viruses, bacteria, and parasites.

“First-generation mRNA vaccines fundamentally changed how we prevent infectious diseases, but they represent only the first step,” said Dr. Carsten Rudolph, CEO of Ethris. “Together with DZIF, we are focused on developing a new generation of mRNA vaccines designed to provide broader and more durable protection beyond individual respiratory viruses. By combining enhanced stability with targeted delivery, these vaccines are intended to be variant-ready, and more easily deployed across different healthcare settings. Our goal is to move vaccination from a largely reactive response to emerging crises toward a proactive, sustainable approach to long-term protection.”

“Our mission is to translate cutting-edge infection research into medical solutions that benefit patients, especially where current prevention and treatment options fall short,” said Dr. Klaus Schwamborn, Head of Vaccine Development at DZIF. “The collaboration with Ethris provides access to an advanced mRNA technology platform that can be applied to emerging pathogens, antimicrobial resistance, and patient groups with limited vaccine response, while accelerating the path of promising concepts toward clinical evaluation.”

Under the agreement, Ethris will grant DZIF access to its Stabilized Non-Immunogenic mRNA (SNIM^®RNA) and Stabilized NanoParticle (SNaP LNP^®) technology platforms, with vaccine materials manufactured by Ethris’ partners, Patheon UK Limited (a Thermo Fisher Scientific company) and Evonik Operations GmbH. These platforms enable the delivery of stabilized, low-immunogenic mRNA across multiple administration routes, supporting the development of next-generation mRNA vaccines. The collaboration grants DZIF access to advanced mRNA and lipid nanoparticle technologies, backed by industrial-scale, quality-controlled manufacturing to support both preclinical and clinical development. With more than a decade of experience in stabilized mRNA therapeutics, Ethris has demonstrated the clinical applicability of its platform through its lead program, ETH47, which is currently in Phase 2a development.

DZIF unites more than 700 scientists and physicians from 35 research institutes across Germany to develop vaccines, diagnostics, and therapies for infectious diseases. With research programs spanning emerging infectious diseases, tuberculosis, hepatitis, HIV, malaria, gastrointestinal infections, and infections in immunocompromised patients, DZIF is dedicated to accelerating the translation of research findings into clinical practice.

About Ethris

Ethris, a clinical-stage biotechnology company, has paved a new path from genes to therapeutic proteins, using its proprietary RNA and lipidoid nanoparticle technology platform to discover, design, and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilized mRNAs directly to the respiratory system via optimized formulation and nebulization technologies. The company is rapidly advancing its mRNA pipeline of immunomodulation, protein replacement therapies, and differentiated vaccines, with the ultimate goal of improving patients’ lives.

For more information, visit www.ethris.com.

About the German Center for Infection Research (Deutsches Zentrum für Infektionsforschung, DZIF)

At the DZIF, more than 700 researchers from 35 institutions across Germany are working together to develop new approaches to the prevention, diagnosis, and treatment of infectious diseases. The goal is translation: the rapid, effective implementation of research results in clinical practice. Through this collaborative effort, the DZIF is paving the way for the development of new vaccines, diagnostics, and drugs against infections.

The DZIF organizes its projects into nine research areas, each focusing on a specific pathogen, disease, or topic within infection research. These areas include “Emerging Infections,” “Healthcare-Associated Infections,” “Novel Antibiotics,” “HIV,” “Hepatitis,” “Tuberculosis,” “Malaria and Neglected Tropical Diseases,” “Community-Acquired Infections at Mucosal Interfaces,” and “Infections of the Immunocompromised Host.” All of these areas aim to effectively transfer research results into clinical applications.

For more information, visit www.dzif.de.

Contacts

Ethris contact:
Dr. Philipp Schreppel

+49 89 244 153 042

schreppel@ethris.com

DZIF contact:
Dr. Klaus Schwamborn

Coordinator of the DZIF Product Development Unit

Head of the DZIF Translational Project Management Office (TPMO)— Vaccine

Coordinator Bridging Topic “Vaccines”

klaus.schwamborn@dzif.de

Median Technologies Receives FDA 510(k) Clearance for eyonis® LCS, the First AI Tech-Based Detection and Diagnosis Device for Lung Cancer Screening




Median Technologies Receives FDA 510(k) Clearance for eyonis® LCS, the First AI Tech-Based Detection and Diagnosis Device for Lung Cancer Screening

• eyonis® LCS aims to redefine lung cancer screening by supporting diagnosis at early, curable stages, while reducing false positives to avoid unnecessary follow-up procedures, and has the potential to help save hundreds of thousands of lives in the US alone
• eyonis® LCS is the only device capable of both detecting and characterizing lung cancer in low-dose CT scans, with 93.3% sensitivity, 92.4% specificity, and 99.9% Negative Predictive Value
• eyonis® LCS’ U.S. market authorization will boost large-scale deployment of lung cancer screening programs for the 14.5 million eligible individuals nationwide
• Existing NT-APC 1508 code enables a predictable reimbursement pathway that will accelerate adoption of eyonis® LCS

SOPHIA ANTIPOLIS, France–(BUSINESS WIRE)–Regulatory News:

Median Technologies (FR0011049824, ALMDT, “Median” or the “Company”), developer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) for early cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, today announced it has received FDA 510(k) clearance for eyonis® LCS, its AI/ML-powered computer-aided detection and diagnosis (CADe/CADx) Software as a Medical Device intended for lung cancer screening.

Lung cancer is the leading cause of cancer death in the United States, and patient outcomes are substantially improved when cancer is identified at early stages. Curable stage 1 lung cancer can be diagnosed through Low-Dose CT (LDCT) screening, yielding ~80% long-term survival versus ≈15% 5-year survival in symptom-detected disease.

By supporting detection and characterization of parenchymal pulmonary nodules on LDCT scans, eyonis® LCS is designed to help clinicians identify suspicious findings earlier, reduce inter-reader variability and improve the efficiency and consistency of lung cancer screening programs.

CEO Statement

“This FDA 510(k) clearance for eyonis® LCS is a major milestone for Median Technologies and an important step toward expanding access to AI-assisted lung cancer screening in the United States. eyonis® LCS is the first end-to-end detection and diagnosis device FDA cleared, specifically targeting lung cancer screenings. We believe eyonis® LCS will prove to be a game changer for clinical teams as they manage rising screening volumes and help healthcare systems deliver high-accuracy and timely lung cancer diagnosis for eligible patients. We are now fully positioned to execute our go-to-market strategy and deploy eyonis® LCS at scale to potentially help save hundreds of thousands of lives in the U.S. alone in the coming years,” said Fredrik Brag, CEO and Founder of Median Technologies.

“Lung cancer screening combined with eyonis® LCS has the capacity to deliver one of the most impactful advances in cancer care by identifying cancer at a stage where it can be cured. eyonis® LCS will empower US clinicians to significantly transform lung cancer patient outcomes. We will now continue leveraging our AI expertise to expand into additional cancer indications — including Incidental Pulmonary Nodules, HCC (liver cancer), pancreatic, colon and prostate cancer— always with the same objective: finding cancer at a stage where it can be cured,” Brag added.

eyonis® LCS establishes a new paradigm in lung cancer screening

eyonis® Lung Cancer Screening (LCS) is designed to analyze imaging data generated from LDCT scans and assist radiologists in detecting and characterizing parenchymal pulmonary nodules, supporting clinical decision-making and patient follow-ups. By enabling earlier identification of suspicious lesions, eyonis® LCS supports diagnosis at stages where patient outcomes can be significantly improved.

In manufacturer performance testing on a lung cancer screening reference population, eyonis® LCS demonstrated 93.3% sensitivity, 92.4% specificity, and a 99.9% Negative Predictive Value (NPV).

The high Negative Predictive Value (NPV) of eyonis® LCS, demonstrates a very low level in false positives (1 per 1,000), which provides clinicians with a high level of diagnostic confidence, enabling them to identify individuals who can remain in standard screening pathways versus those requiring recall, avoiding unnecessary follow-up procedures.

In addition to performance, eyonis® LCS is engineered to integrate seamlessly into existing healthcare workflows, enhancing diagnosis accuracy, and reducing routine workload. eyonis® LCS can be directly integrated into hospital Picture Archiving and Communication Systems (PACS).

eyonis® LCS will help improve adherence to screening programs, enabling healthcare systems to deliver more consistent, high-quality patient care.

Approximately 14.5 million people are currently eligible for lung cancer screening in the United States, and eyonis® LCS benefits from an established reimbursement framework, creating a highly favorable environment for rapid scale.

The USPSTF eligible population for lung cancer screening using LDCT in the United States includes adults aged 50 to 80 years with a 20-pack-year smoking history. Based on current eligibility criteria, 14.5 million individuals qualify for screening, and this population is expected to increase over time as screening guidelines expand.

Median Technologies believes that eyonis® LCS can play a major role in helping healthcare systems expand access to screening, reduce operational burden, and support more standardized parenchymal nodule evaluation, particularly as screening volumes grow amid a worsening shortage of radiologists.

This opportunity is supported by an existing reimbursement framework: AI-driven CT tissue characterization is reimbursed under Category III CPT codes 0721T and 0722T, both assigned to New Technology APC 1508, with Medicare payments ranging from $601–$700. These codes provide a predictable payment pathway that accelerates adoption of advanced AI medical devices among U.S. imaging providers. eyonis® LCS is positioned to leverage this established reimbursement pathway, generating immediate economic value for imaging providers and accelerating nationwide adoption.

Median plans to commercialize eyonis® LCS in the United States through a combination of direct enterprise sales, strategic distribution partnerships, and integration into existing clinical environments. Median will utilize the current CMS reimbursement framework, including applicable New Technology APC pathways, while working toward broader, long-term insurance coverage.

The Company will provide further details regarding the commercial launch in the coming weeks.

Alongside its U.S. rollout, the Company continues to advance the European regulatory pathway and expects CE marking in Q2 2026, expanding access to this technology to hundreds of thousands of patients in Europe.

About Median Technologies: Pioneering innovative software as a medical device and imaging services, Median Technologies harnesses cutting-edge AI to enhance the accuracy of early cancer diagnoses and treatments. Median’s offerings include iCRO, which provides medical image analysis and management in oncology trials, and eyonis®, an AI/ML tech-based suite of software as a medical device (SaMD). Median empowers biopharmaceutical entities and clinicians to advance patient care and expedite the development of novel therapies. The French-based company, with a presence in the U.S. and China, trades on the Euronext Growth market (ISIN: FR0011049824, ticker: ALMDT). Median is also eligible for the French SME equity savings plan scheme (PEA-PME). For more information, visit www.mediantechnologies.com.

Forward-Looking Statements

This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance.

These forward-looking statements can often be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” or “plans” and any other similar expressions. Although Median’s management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release. Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers.

Contacts

MEDIAN TECHNOLOGIES
Emmanuelle Leygues
VP, Corporate Marketing & Financial Communications

+33 6 10 93 58 88

emmanuelle.leygues@mediantechnologies.com

Press – MAARC
Bruno Arabian
+33 6 87 88 47 26

bruno.arabian@maarc.fr
Nicolas Entz
+33 6 33 67 31 54

nicolas.entz@maarc.fr

Investors – SEITOSEI ACTIFIN
Ghislaine Gasparetto
+33 6 85 36 76 81

ghislaine.gasparetto@seitosei-actifin.com

U.S. media – TODD STEIN COMMUNICATIONS
Todd Stein
+1 510.417.0612

todd@toddsteincommunications.com

Evinova and Bristol Myers Squibb Forge Strategic Collaboration to Optimize Clinical Development with Artificial Intelligence




Evinova and Bristol Myers Squibb Forge Strategic Collaboration to Optimize Clinical Development with Artificial Intelligence

Agreement will leverage Evinova’s innovative AI-native platform to improve trial design, accelerate timelines, and enhance cost efficiency

BAAR, Switzerland–(BUSINESS WIRE)–Evinova today announced that Bristol Myers Squibb has signed an agreement to optimize clinical trials with Evinova’s AI-native clinical development platform. Under the terms of the agreement, Bristol Myers Squibb will deploy the Cost Optimizer module of Evinova’s Study Designer across the company’s global portfolio, harnessing advanced artificial intelligence to improve insight-driven decision making, identify productivity opportunities, and unlock more efficient trial designs that accelerate innovation and improve experience for sites and patients.

“Drug development is changing rapidly, and life science companies need partners who bring both AI leadership and clinical development expertise to successfully drive transformation,” said Cristina Duran, President of Evinova. “Evinova, founded by pharma for pharma, combines AI innovation with deep industry insight to reimagine clinical development. We’re thrilled to collaborate with Bristol Myers Squibb to drive efficiencies in drug development and accelerate breakthroughs for patients.”

“Transforming clinical development is not just an opportunity; it is an urgent necessity,” said Cristian Massacesi, MD, EVP, Chief Medical Officer & Head of Development at Bristol Myers Squibb. “For years, developing medicines has taken too long, cost too much money, and mostly resulted in failure. Digital tools and AI can help us overcome these limitations and lay the foundation for better health outcomes for countless individuals in the years to come. The decisions we make now will shape the future of medicine, accelerate progress and ensure that the benefits of scientific advancement reach those who need them most.”

Enhancing Value with Evinova’s AI-Native Platform Solutions

Evinova’s industry-leading AI-native platform for clinical development harnesses agentic AI to enhance study design, streamlines processes through collaboration and enables seamless digital data flow in USDM standards. The platform also incorporates robust controls and safeguards to ensure the responsible integration of AI into clinical development. The end-to-end platform is globally scaled and brings together functionality that has delivered hundreds of millions of dollars in multi-year savings for customers.

Complementing the trial optimization solutions, Evinova’s Unified Trial Solution integrates critical study elements into an improved, connected trial experience for sponsors, sites and patients. The Unified Trial Solution app seamlessly integrates eCOA with telehealth and connected devices for remote patient monitoring (RPM) for toxicity management, removing friction points and enabling robust data collection for novel endpoints and innovative trial designs. Evinova’s human-centered approach to product development incorporates input from patients and trial site teams, evidenced by industry-leading eCOA compliance metrics and user engagement scores.

Solutions on Evinova’s AI platform are proven to accelerate timelines, reduce costs, improve data quality, enhance patient experiences, reduce the duration of adverse events and ultimately achieve better outcomes.

Partner with Us to Advance Clinical Development

Evinova invites forward-thinking organizations to join us in redefining a future where clinical development is faster, more efficient, and truly patient-centric. Pharma, biotech and CROs interested in working with us can reach out here.

About Evinova

Evinova empowers life science leaders to accelerate better health outcomes. Purpose-built by healthcare for healthcare, Evinova delivers intelligently designed digital and AI-native solutions that optimize the entire clinical development lifecycle from end to end. With proven outcomes published in Nature Medicine, Evinova’s solutions and strategies have demonstrated up to 60% improvement in patient experience, 6-month acceleration in trial delivery, and 32% reduction in costs. Evinova is a separate health tech company within the AstraZeneca group. Learn more about Evinova at www.evinova.com or on social media @Evinova.

Contacts

Media Contact:
Heather Bonsiero

Director of Communications and Marketing

Evinova

heather.bonsiero@evinova.com

Genentech’s Fenebrutinib Is the First Investigational Medicine in Over a Decade That Reduces Disability Progression in Primary Progressive Multiple Sclerosis (PPMS)




Genentech’s Fenebrutinib Is the First Investigational Medicine in Over a Decade That Reduces Disability Progression in Primary Progressive Multiple Sclerosis (PPMS)

– Late-breaking Phase III FENtrepid results presented at ACTRIMS show investigational fenebrutinib met its primary endpoint of non-inferiority compared to the current standard of care, Ocrevus, in reducing disability progression in PPMS –

– Fenebrutinib numerically reduced the risk of disability progression by 12% compared to Ocrevus as early as 24 weeks; additional analysis showed potential benefit in upper limb function –

– Fenebrutinib has the potential to become first-in-class in multiple sclerosis, as an oral, brain-penetrant BTK inhibitor for PPMS and relapsing multiple sclerosis (RMS) –

– Regulatory submission for fenebrutinib in both PPMS and RMS is planned following the Phase III FENhance 1 readout, expected mid first half of 2026 –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new late-breaking data from the Phase III FENtrepid study showing the investigational Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib met its primary endpoint of non-inferiority compared to Ocrevus^® (ocrelizumab) in reducing disability progression in patients with primary progressive multiple sclerosis (PPMS). Fenebrutinib showed a 12% reduction in the risk of disability progression compared to Ocrevus, the only approved medicine for PPMS, as measured by the time to onset of 12-week composite confirmed disability progression (cCDP12) (hazard ratio [HR] 0.88; 95% confidence interval [CI]: 0.75, 1.03) with curves separating as early as 24 weeks. A consistent treatment effect on cCDP12 was observed across patient subgroups and for the entire treatment duration.

The cCDP12 primary endpoint included the confirmed disability progression (CDP) based on the Expanded Disability Status Scale (EDSS) for functional disability, the timed 25-foot walk (T25FW) for walking speed and the nine-hole peg test (9HPT) for upper limb function. The strongest treatment effect was observed on the risk of worsening on the 9HPT by 26% (HR 0.74; 95% CI: 0.56, 0.98) compared to Ocrevus.

“Fenebrutinib showed a consistent clinical benefit as early as week 24, notably in upper limb function, which is essential for preserving independence and daily functioning,” said Professor Amit Bar-Or, Director of the Center for Neuroinflammation and Neurotherapeutics, Perelman School of Medicine, University of Pennsylvania. “With only one disease-modifying therapy available for people with PPMS, fenebrutinib has the potential to be a high-efficacy, oral treatment option that acts directly in the brain, targeting progressive biology, and may slow disability.”

“Fenebrutinib represents the first potential scientific breakthrough for the PPMS community in over a decade, demonstrating a meaningful clinical benefit in reducing disability progression in a study versus the only approved treatment in PPMS,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We look forward to advancing our regulatory submission following the upcoming readout of our second pivotal RMS study, FENhance 1.”

Additionally, a post-hoc analysis showed that fenebrutinib was superior to Ocrevus on a composite endpoint including two of the three components of cCDP12 (EDSS and 9HPT), with a 22% reduction in risk (HR 0.78; 95% CI: 0.64, 0.95).

Adverse events (AEs) commonly (≥10%) observed in the fenebrutinib group were comparable to Ocrevus: infections (67.0% vs 70.9%), nausea (12.0% vs 7.1%) and hemorrhage (10.2% vs 8.1%). Transient and reversible liver enzyme elevations were observed more often in the fenebrutinib group (13.3% vs 2.9%), and all cases resolved after study drug discontinuation. No Hy’s law cases (an indicator for potential severe liver injury) were observed. Serious AEs were reported in 19.1% of patients receiving fenebrutinib (vs 18.9% on Ocrevus) and led to 4.3% withdrawing from treatment (vs 3.0% on Ocrevus). In the FENtrepid study there were 1.4% fatal cases in the fenebrutinib arm vs 0.2% in the Ocrevus arm, all of which were assessed as unrelated to the study treatment by the investigators and no pattern was observed in timing or cause. Epidemiological studies have shown that fatality rates are higher in people living with MS compared to the general population.^1-4

Results were shared today as a late-breaking oral presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026 in San Diego, California. These data follow Genentech’s announcement in November 2025 that the FENtrepid study and the first of two Phase III relapsing multiple sclerosis (RMS) studies (FENhance 2) met their primary endpoints. Once the second RMS study (FENhance 1) has read out, which is expected in the first half of 2026, data from all Phase III fenebrutinib trials will be submitted to regulatory authorities.

About the FENtrepid study

FENtrepid is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of fenebrutinib compared with Ocrevus in 985 adult patients with PPMS. Eligible participants were randomized 1:1 to receive treatment with either daily oral fenebrutinib (and placebo matched to intravenous [IV] Ocrevus) or IV Ocrevus (and placebo matched to oral fenebrutinib) for at least 120 weeks.

The primary endpoint is the time to onset of 12-week composite confirmed disability progression (cCDP12). The cCDP incorporates three measures of disability – total functional disability measured by the Expanded Disability Status Scale (EDSS), walking speed measured by the timed 25-foot walk (T25FW), and upper limb function measured by the nine-hole peg test (9HPT). This comprehensive composite endpoint offers greater sensitivity than the EDSS alone, capturing additional aspects of disability and often earlier. Key secondary endpoints include the time to onset of 24-week composite confirmed disability progression (cCDP24), 12-week confirmed disability progression (CDP12) and 24-week confirmed disability progression (CDP24).

Following the double-blind treatment period, patients have the option to enter an open-label extension (OLE) phase, in which all patients receive treatment with fenebrutinib.

About fenebrutinib

Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimized pharmacokinetics (PK) profile and high potency. While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib binds and then eventually releases the enzyme. These design features may help limit off-target effects.

Fenebrutinib has a selectivity for BTK 130 times greater than other kinases which means that it can bind to its intended BTK target without interfering in other kinases. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression.

The fenebrutinib Phase III program includes two similarly designed trials in relapsing multiple sclerosis (RMS) (FENhance 1 and 2) with active comparator teriflunomide and the only trial in primary progressive multiple sclerosis (PPMS) (FENtrepid) in which a BTK inhibitor is being evaluated against Ocrevus.

To date, more than 2,700 patients and healthy volunteers have been treated with fenebrutinib in Phase I, II and III clinical programs across multiple diseases, including multiple sclerosis and other autoimmune disorders.

About Ocrevus^® (ocrelizumab)

Ocrevus is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo^® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both Ocrevus IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months.

About multiple sclerosis

Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.

Approximately 85% of people with multiple sclerosis have a relapsing form of the disease (RMS) characterized by relapses and also worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus^®, there had been no FDA-approved treatments for PPMS and Ocrevus is still the only approved treatment for PPMS.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Genentech

Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Indications and Important Safety Information

What are Ocrevus and Ocrevus Zunovo?

Ocrevus and Ocrevus Zunovo are prescription medicines used to treat:

• Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
• Primary progressive MS, in adults.

It is not known if Ocrevus and Ocrevus Zunovo are safe and effective in children.

Who should not receive Ocrevus or Ocrevus Zunovo?

Do not receive Ocrevus or Ocrevus Zunovo if you:

• have an active hepatitis B virus (HBV) infection.
• have had a life-threatening administration reaction to ocrelizumab.
• have had a life-threatening allergic reaction to ocrelizumab, hyaluronidase, or any of the ingredients of Ocrevus Zunovo. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or Ocrevus Zunovo or any of their ingredients in the past.

What is the most important information I should know about Ocrevus and Ocrevus Zunovo?

Ocrevus and Ocrevus Zunovo can cause serious side effects, including:

• Infusion reactions (Ocrevus): Infusion reactions are a common side effect of Ocrevus, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction.
• Injection reactions (Ocrevus Zunovo): Injection reactions are a common side effect of Ocrevus Zunovo, which can be serious and may require you to be hospitalized. You will be monitored for signs and symptoms of an injection reaction when you receive Ocrevus Zunovo. This will happen during all injections for at least 1 hour after your first injection, and for at least 15 minutes after all injections following the first injection.

Tell your healthcare provider or nurse if you get any of these symptoms:

• Itchy skin
• Rash
• Hives
• Tiredness
• Coughing or wheezing
• Trouble breathing
• Throat irritation or pain
• Feeling faint
• Fever
• Redness on your face (flushing)
• Nausea
• Headache
• Swelling of the throat
• Dizziness
• Shortness of breath
• Fatigue
• Fast heartbeat

Additionally, for Ocrevus Zunovo:

• Injection site pain
• Swelling
• Redness

These infusion and injection reactions can happen during or up to 24 hours after administration. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion or injection.

• Infection:
  • Infections are a common side effect. Ocrevus and Ocrevus Zunovo increase your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus and Ocrevus Zunovo, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus or Ocrevus Zunovo. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus or Ocrevus Zunovo until your infection is gone.
  • Hepatitis B virus (HBV) reactivation: Before starting treatment with ocrelizumab, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus or Ocrevus Zunovo. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus or Ocrevus Zunovo.
  • Weakened immune system: Ocrevus or Ocrevus Zunovo taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with ocrelizumab. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
  • Thinking
  • Eyesight
  • Strength
  • Balance
  • Weakness on 1 side of your body
  • Using your arms or legs
• Decreased immunoglobulins: Ocrevus and Ocrevus Zunovo may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Before receiving Ocrevus or Ocrevus Zunovo, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection. See “What is the most important information I should know about Ocrevus and Ocrevus Zunovo?”
• have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS. These medicines could increase your risk of getting an infection.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have a history of inflammatory bowel disease or colitis.
• have a history of liver problems.
• have had a recent vaccination or are scheduled to receive any vaccinations.
• You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Ocrevus or Ocrevus Zunovo. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Ocrevus or Ocrevus Zunovo and until your healthcare provider tells you that your immune system is no longer weakened.
• When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Ocrevus or Ocrevus Zunovo. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus or Ocrevus Zunovo, talk to your healthcare provider.
• If you have a baby and you received Ocrevus or Ocrevus Zunovo during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Ocrevus or Ocrevus Zunovo so they can decide when your baby should be vaccinated.
• are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus and Ocrevus Zunovo will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and Ocrevus Zunovo and for 6 months after your last dose of Ocrevus or Ocrevus Zunovo. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider if you become pregnant while receiving Ocrevus or Ocrevus Zunovo.
• are breastfeeding or plan to breastfeed. It is not known if Ocrevus and Ocrevus Zunovo pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus or Ocrevus Zunovo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Ocrevus and Ocrevus Zunovo?

Ocrevus and Ocrevus Zunovo may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer: Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
• Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
  • Diarrhea (loose stools) or more frequent bowel movements than usual
  • Stools that are black, tarry, sticky or have blood or mucus
  • Severe stomach-area (abdomen) pain or tenderness
• Liver damage: Ocrevus and Ocrevus Zunovo may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start Ocrevus or Ocrevus Zunovo and while you take Ocrevus or Ocrevus Zunovo if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as:
  • yellowing of the skin and eyes (jaundice)
  • nausea
  • vomiting
  • unusual darkening of the urine
  • feeling tired or weak

The most common side effects of Ocrevus Zunovo include:

• Injection reactions
• Respiratory tract infections
• Skin infections

These are not all the possible side effects of Ocrevus and Ocrevus Zunovo.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.

For more information, go to https://www.Ocrevus.com or call 1-844-627-3887.

For additional safety information, please see the full Prescribing Information and Medication Guide for Ocrevus.

For additional safety information, please see the full Prescribing Information and Medication Guide for Ocrevus Zunovo.

References

¹ Manouchehrinia A, et al. Mortality in multiple sclerosis: meta-analysis of standardised mortality ratios. J Neurol Neurosurg Psychiatry. 2016;87:324–331.

² Smyrke N, et al. Standardized mortality ratios in multiple sclerosis: Systematic review with meta-analysis. Acta Neurol Scand. 2021;00:1–11.

³ Scalfari A, et al. Mortality in patients with multiple sclerosis. Neurology. 2013;81:184–192.

⁴ Kingwell E, et al. Causes that Contribute to the Excess Mortality Risk in Multiple Sclerosis: A Population-Based Study. Neuroepidemiology. 2020;54:131–139

Contacts

Media Contact:

Michelle McCourt, (650) 467-6800

Advocacy Contact:

Lily Rose Atherton, (202) 713-0083

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 687 5284

Johnson & Johnson Presents Early Outcomes from the OMNY-AF Pilot Study at 2026 AF Symposium




Johnson & Johnson Presents Early Outcomes from the OMNY-AF Pilot Study at 2026 AF Symposium

OMNY-AF pilot study reports 90% 12-month freedom from AFib with zero procedure-related adverse eventsⁱ

Additional data presented further reinforces the favorable and consistent safety and efficiency profile of the VARIPULSE platform^ii,iii,iv,v

IRVINE, Calif.–(BUSINESS WIRE)–Johnson & Johnson today announced 12-month pilot-phase data from the OMNY-AF study, evaluating the investigational OMNYPULSE Platform for the treatment of symptomatic paroxysmal atrial fibrillation (AFib), during the 31st Annual AF Symposium in Boston. Initial results for 12-month outcomes across the 30-patient pilot cohort show investigators achieved 100% acute procedural success with no procedure-associated adverse events, while 56.7% of cases were performed with zero fluoroscopy and 90% of patients achieved primary effectiveness at 12 months.ⁱ

OMNY-AF is a prospective, single-arm, multi-center clinical trial conducted across more than 40 sites in the U.S. and Australia.^vi The study pairs the OMNYPULSE Catheter, a 12 mm large-tip focal catheter featuring contact-force sensing and bipolar, biphasic pulse delivery with the TRUPULSE Generator. This integrated design combines precise mapping, controlled energy delivery and live feedback through the PF index on the CARTO 3 System.^vii The OMNYPULSE Platform is not currently approved in any region of the world.

“The 12-month data provide encouraging early evidence on the OMNY-AF study with promising safety outcomes – no procedure-related adverse events or MRI-detected cerebral lesions – across eight centers in the pilot phase ⁱ. In my cases during the ongoing OMNY-AF trial, the seamless integration of advanced mapping, ultrasound, and PF Index with contact force were valuable for precise and efficient pulsed field energy delivery,” said Dinesh Sharma, M.D.¹, Section Head of Cardiac Electrophysiology at the Naples Heart Institute, the study presenting author.

Alongside the OMNY-AF data, Johnson & Johnson is highlighting new findings related to the VARIPULSE Platform. Data presented by Andrea Natale, M.D.², and simultaneously published in JACC Clin Electrophysiology, by Moussa Mansour, M.D.³ examined the incidence of neurovascular events following the workflow enhancements and the introduction of an optimized irrigation flow rate. Notably, the platform sustained a low neurovascular event rate of 0.22% in 6,811 patients after implementation of both workflow enhancements and the updated irrigation rate.ⁱⁱ

Additional VARIPULSE Platform data presented at AF Symposium adds to the growing body of evidence underscoring the platform’s consistent and favorable safety profile across a range of clinical and real-world settings, including:

• VARISURE Safety survey data presented by Christopher Porterfield, M.D.⁴: Early results from this physician survey on 850 procedures indicated low complication rates with a 1.9% rate of primary adverse events, a 0.2% incidence of neurovascular events and no reported cases of coronary spasm or death. Same-day discharge was achieved in 87.9% of patients.ⁱⁱⁱ
• REAL AF registry analysis presented by Mohammad-Ali Jazayeri, M.D.⁵: Results from the REAL AF registry showed excellent acute safety outcomes of the VARIPULSE Catheter, with a low overall acute safety event rate of 0.5% with no neurovascular events, high rates of same-day discharge and no observed differences in safety outcomes across AFib classifications.^iv
• Irrigation Flow Optimization research presented by Fengwei Zou, M.D.⁶: Preclinical data demonstrated parity between the 4 mL/min and 30 mL/min irrigation rates in microbubble generation, hemolysis and lesion depth when using the VARIPULSE Catheter, while confirming that higher irrigation significantly reduced electrode surface heating.^v

“These data reinforce confidence in the consistency of safety outcomes observed across Johnson & Johnson’s electrophysiology portfolio. As a relatively new energy modality, pulse field ablation technologies should be individually evaluated for safety and reproducibility in atrial fibrillation ablation,” said Gregory Michaud, M.D., Chief Medical and Scientific Officer, Electrophysiology, MedTech, Johnson & Johnson. “As pulsed field ablation continues to evolve, rigorous evidence generation and transparent data sharing will be essential to advancing the science and enabling the next wave of innovation with this technology.”

Johnson & Johnson remains committed to evidence-driven innovation that advances patient care and informs clinical decision-making across its electrophysiology portfolio. These efforts are supported by the CARTO 3 System, the world’s leading cardiac mapping system⁷.

About The OMNY-AF Study

The OMNY-AF study is a prospective, single-arm, multi-center study evaluating the clinical safety and effectiveness of the OMNYPULSE Catheter for the treatment of symptomatic paroxysmal AFib. Up to 440 enrolled subjects will undergo an ablation procedure with the OMNYPULSE Platform. The primary safety endpoint in the study is the occurrence of Primary Adverse Events within seven days of the ablation procedure. The primary effectiveness endpoint is freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia episodes based on electrocardiographic data and additional failure modes during the effectiveness evaluation period over a 12-month period.

About the VARIPULSE Platform

The VARIPULSE Platform is Johnson & Johnson MedTech’s Pulsed Field ablation system. The fully integrated platform includes the VARIPULSE Catheter, TRUPULSE Generator, and CARTO 3 Mapping System VARIPULSE Software. The Platform is now approved for use in the United States, Europe, Asia Pacific, Canada, and Latin America.

Cardiovascular Solutions from Johnson & Johnson MedTech

Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration, and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more, visit biosensewebster.com.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more about our MedTech sector’s global scale and deep expertise in surgery, orthopaedics, vision, and cardiovascular solutions at https://thenext.jnjmedtech.com. Follow us at @JNJMedTech and on LinkedIn.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to Collaborative Outcomes Registry for Evidence in Ventricular Arrhythmias. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: competition, including technological advances, new products and patents attained by competitors; uncertainty of commercial success for new products; the ability of the company to successfully execute strategic plans; impact of business combinations and divestitures; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and global health care reforms and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

© Johnson & Johnson and its affiliates 2026. All rights reserved. US_ELP_THER_411898

Contacts

Media Contacts:
Erin Farley

Efarley1@its.jnj.com

Majo Echeverria

MEchever@its.jnj.com

Geneoscopy Wins Second Patent Trial and Appeal Board Decision, Invalidating All Challenged Claims of Exact Sciences’ ’746 Patent




Geneoscopy Wins Second Patent Trial and Appeal Board Decision, Invalidating All Challenged Claims of Exact Sciences’ ’746 Patent

Decision removes last patent hurdle as Geneoscopy advances ColoSense®, its RNA-based noninvasive colorectal cancer screening test

ST. LOUIS–(BUSINESS WIRE)–Geneoscopy, Inc., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has issued a Final Written Decision following inter partes review (IPR), finding all 10 challenged claims of Exact Sciences’ U.S. Patent No. 11,970,746 (the ’746 patent) unpatentable. This decision follows the PTAB’s July 2025 Final Written Decision invalidating all 20 claims of Exact Sciences’ U.S. Patent No. 11,634,781 (the ‘781 patent). As a result, all patent claims asserted by Exact Sciences against the company in the parties’ ongoing litigation have now been invalidated by the PTAB.

The PTAB’s ruling concluded that all claims of the ’746 patent challenged by the company before the PTAB are unpatentable in view of prior art describing stool sample collection and processing. The PTAB’s decision to invalidate all challenged claims of the ‘746 patent, following its final decision invalidating all claims of the ‘781 patent, further confirms Geneoscopy’s long-held position and clears the path for the continued commercialization of ColoSense.

“The PTAB’s final decisions on these two patents validate what we have believed all along—that the claims in both the ’781 patent and the ‘746 patent being asserted by Exact Sciences against the company should never have been issued,” said Andrew Barnell, CEO and co-founder of Geneoscopy. “This outcome underscores that invalid patents cannot be used to limit patient access to life-saving colorectal cancer screening options like ColoSense. These final decisions are also a critical step toward protecting patient choice and advancing high-quality, innovative, noninvasive screening solutions.”

Geneoscopy filed the IPR petition after Exact Sciences initiated a patent infringement suit against the company in the U.S. District Court for the District of Delaware. The PTAB’s ruling on the ‘746 patent removes all of Exact Sciences’ patent challenges against ColoSense in that case, as all patent claims asserted against the company in the litigation have now been invalidated by the PTAB.

As part of the litigation, Geneoscopy has filed counterclaims against Exact Sciences alleging breach of contract, misappropriation of trade secrets, false advertising, and unfair competition (Exact Sciences Corporation v. Geneoscopy, Inc., C.A. No. 23-1319-MN (D. Del.)).

About ColoSense

ColoSense is intended for the qualitative detection of colorectal neoplasia-associated RNA markers and for the presence of occult hemoglobin in human stool. ColoSense is for use with the ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense Software, and the following instruments: Polymedco iFOBT Analyzer; bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx ddPCR System. ColoSense is a single-site test performed at Geneoscopy, Inc. A positive ColoSense result may indicate the presence of colorectal cancer (CRC), advanced adenomas (AA), or serrated precancerous lesions (SPL) and should be followed by a colonoscopy. ColoSense is indicated as a screening test for adults aged 45 years or older who are at the typical average risk for developing CRC. ColoSense is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Results from Geneoscopy’s pivotal CRC-PREVENT trial were published in The Journal of the American Medical Association (JAMA) in October 2023. For more information, visit www.colosense.com.

About Geneoscopy, Inc.

Geneoscopy, Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company’s FDA-approved ColoSense test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other areas of gastrointestinal health. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

Contacts

Investor Contact:
Amit Bhalla

Chief Financial Officer

314 887 7777

Amit.Bhalla@geneoscopy.com

Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2025




Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2025

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today reported fourth quarter and full-year 2025 financial results.

Visit the company’s Investor Relations website at http://investor.bms.com to view the detailed fourth quarter and full-year 2025 earnings press release and investor presentation.

The company will host a conference call and live audio webcast for analysts and investors at 8:00 a.m. ET today, February 5, 2026, which is accessible here. Company executives will review financial results with the investment community during the call.

A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes.

About Bristol Myers Squibb: Transforming Patients’ Lives Through Science

At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

corporatefinancial-news

Contacts

For more information, contact:
Media Relations: media@bms.com
Investor Relations: investor.relations@bms.com

Omnicell Announces Fiscal Year and Fourth Quarter 2025 Financial Results




Omnicell Announces Fiscal Year and Fourth Quarter 2025 Financial Results

Omnicell delivers solid fourth quarter 2025 financial results

Announces major step toward autonomous medication management with the launch of its next generation dispensing system, Titan XT, at the American Society of Health-System Pharmacists (ASHP) 2025 Midyear Clinical Meeting & Exhibition

FORT WORTH, Texas–(BUSINESS WIRE)–Omnicell, Inc. (NASDAQ:OMCL) (“Omnicell,” “we,” “our,” “us,” “management,” or the “Company”), a leading healthcare technology provider focused on empowering autonomous medication management, today announced results for its fiscal year and fourth quarter ended December 31, 2025.

“We finished 2025 with solid fourth quarter financial results, delivering full year 2025 total revenues, product bookings and annual recurring revenues (‘ARR’) all above the mid-point of our previously issued guidance ranges,” stated Randall Lipps, chairman, president, chief executive officer, and founder of Omnicell. “As we look ahead, we are focused on delivering long-term, sustainable, and profitable growth. The launch of Titan XT intends to address a significant need for an enhanced and more efficient medication management experience that combines proven automation with powerful intelligence and extends beyond the pharmacy into nursing care areas. We believe that our innovation roadmap continues to resonate with our customers, and I am optimistic for what the future holds for Omnicell in 2026 and beyond.”

Financial Results

Total revenues for the fourth quarter of 2025 were $314 million, up $7 million, or 2%, from the fourth quarter of 2024. The quarter-over-quarter increase in total revenues was driven by strength in our technical service offerings and SaaS and Expert Services revenues, as well as increases in our consumables revenues. Total revenues for the year ended December 31, 2025 were $1.185 billion, up $73 million, or 7%, from the year ended December 31, 2024. The year-over-year increase in total revenues was driven by strength in our connected devices and technical service offerings, as well as increases in our SaaS and Expert Services and consumables revenues.

Total GAAP net loss for the fourth quarter of 2025 was $2 million, or $0.05 per diluted share. This compares to GAAP net income of $16 million, or $0.34 per diluted share, for the fourth quarter of 2024. Total GAAP net income for the year ended December 31, 2025 was $2 million, or $0.04 per diluted share. This compares to GAAP net income of $13 million, or $0.27 per diluted share, for the year ended December 31, 2024.

Total non-GAAP net income for the fourth quarter of 2025 was $18 million, or $0.40 per diluted share. This compares to non-GAAP net income of $28 million, or $0.60 per diluted share, for the fourth quarter of 2024. Total non-GAAP net income for the year ended December 31, 2025 was $75 million, or $1.62 per diluted share. This compares to non-GAAP net income of $79 million, or $1.71 per diluted share, for the year ended December 31, 2024.

Total non-GAAP EBITDA for the fourth quarter of 2025 was $37 million. This compares to non-GAAP EBITDA of $46 million for the fourth quarter of 2024. Total non-GAAP EBITDA for the year ended December 31, 2025 was $140 million. This compares to non-GAAP EBITDA of $136 million for the year ended December 31, 2024.

Product Bookings, Product Backlog and Annual Recurring Revenue

We utilize product bookings⁽¹⁾ and Annual Recurring Revenue (“ARR”), each as further described below, as key performance metrics for our business. For the year ended December 31, 2025, product bookings were $535 million compared to $558 million for the year ended December 31, 2024, or a decrease of 4% year-over-year, as we are in the late stage of the XT upgrade cycle. The chart below summarizes our total product backlog ⁽²⁾ and ARR ⁽³⁾:

Balance Sheet

As of December 31, 2025, Omnicell’s balance sheet reflected cash and cash equivalents of $197 million, total debt (net of unamortized debt issuance costs) of $168 million, and total assets of $1.97 billion. Cash flows provided by operating activities in the fourth quarter of 2025 totaled $30 million. This compares to cash flows provided by operating activities totaling $56 million in the fourth quarter of 2024.

As of December 31, 2025, the Company had $350 million of availability under its revolving credit facility with no outstanding balance.

Corporate Highlights

• In December 2025, the Company announced Omnicell Titan XT, a transformational, enterprise version of automated dispensing systems (ADS). Designed to unify proven automation and powerful intelligence, Titan XT is built to deliver an enhanced and more efficient medication management experience to support a growing health system. With this launch, the power of OmniSphere is meant to extend to nursing care areas, designed to deliver greater control of medication inventory management for pharmacy, while providing nurses with more confidence when administering medications.

• More than 4,000 pharmacy leaders connected with Omnicell during December’s American Society of Health-System Pharmacists (ASHP) Midyear 2025 Clinical Meeting and Exhibition, where they had the opportunity to explore how Omnicell is working to empower autonomous medication management to drive intelligent outcomes, deliver a better clinician experience, expand visibility and oversight for pharmacy enterprise, enhance safety and accuracy in the IV cleanroom, and transform outpatient care delivery.

• Omnicell was once again recognized as one of the Top 50 Healthcare Technology Companies by the Healthcare Technology Report for continuous focus on innovation designed to help healthcare organizations deliver better, more precise care. Randall Lipps was also named one of the Top Healthcare Technology CEOs of 2025 by the Healthcare Technology Report.

2026 Guidance

The table below summarizes Omnicell’s first quarter and full year 2026 guidance:

The Company does not provide guidance for GAAP net income or GAAP earnings per share, nor a reconciliation of any forward-looking non-GAAP financial measures to the most directly comparable GAAP financial measures on a forward-looking basis because it is unable to predict certain items contained in the GAAP measures without unreasonable efforts. These forward-looking non-GAAP financial measures do not include certain items, which may be significant, including, but not limited to, unusual gains and losses, costs associated with future restructurings, acquisition-related expenses, and certain tax and litigation outcomes.

Omnicell Conference Call Information

Omnicell will hold a conference call today, Thursday, February 5, 2026, at 8:30 a.m. ET to discuss fiscal year and fourth quarter 2025 financial results. The conference call can be monitored by dialing (800) 715-9871 in the U.S. or (646) 307-1963 in international locations. The Conference ID is 4203777. A link to the live and archived webcast will also be available on the Investor Relations section of Omnicell’s website at https://ir.omnicell.com/events-and-presentations/.

About Omnicell

Since 1992, Omnicell has been committed to delivering innovative, outcomes-centric pharmacy and nursing solutions for all settings of care. As an intelligent medication management technology company, Omnicell empowers autonomous medication management by unifying automation and AI-enabled intelligence, optimized by expert services, to drive clinical and business outcomes that are helping to improve efficiency and enhance patient safety for healthcare facilities worldwide. Learn more at omnicell.com.

From time to time, Omnicell may use the Company’s investor relations website and other online social media channels, including its LinkedIn page www.linkedin.com/company/omnicell, and Facebook page www.facebook.com/omnicellinc, to disclose material non-public information and comply with its disclosure obligations under Regulation Fair Disclosure (“Reg FD”).

OMNICELL and the Omnicell logo are registered trademarks of Omnicell, Inc. or one of its subsidiaries. This press release may also include the trademarks and service marks of other companies. Such trademarks and service marks are the marks of their respective owners.

Forward-Looking Statements

To the extent any statements contained in this press release deal with information that is not historical, these statements are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, statements including the words “expect,” “intend,” “may,” “will,” “should,” “would,” “could,” “plan,” “potential,” “anticipate,” “believe,” “forecast,” “guidance,” “outlook,” “goals,” “target,” “estimate,” “seek,” “predict,” “project,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to the occurrence of many events outside Omnicell’s control. Such statements include, but are not limited to, Omnicell’s projected product bookings, revenues, including product, service, technical services and SaaS and Expert Services revenues, annual recurring revenue, non-GAAP EBITDA, and non-GAAP earnings per share; expectations regarding our products and services and developing new or enhancing existing products and solutions and the related objectives and expected benefits (and any implied financial impact); our customers’ receptivity to our innovation roadmap; our ability to deliver innovations that are designed to provide an enhanced and more efficient medication management experience extending beyond the pharmacy into nursing care areas; our customers’ expectations regarding tariffs and regulations; our ability to deliver sustainable and profitable growth, and statements about Omnicell’s strategy, plans, objectives, promise and purpose, vision, goals, opportunities, and market or Company outlook. Actual results and other events may differ significantly from those contemplated by forward-looking statements due to numerous factors that involve substantial known and unknown risks and uncertainties. These risks and uncertainties include, among other things, (i) unfavorable general economic and market conditions, including the impact and duration of inflationary pressures, (ii) Omnicell’s ability to take advantage of growth opportunities and develop and commercialize new solutions and enhance existing solutions, (iii) reduction in demand in the capital equipment market or reduction in the demand for or adoption of our solutions, systems, or services, (iv) delays in installations of our medication management solutions or our more complex medication packaging systems, (v) our international operations may subject us to additional risks, including from the impact of tariffs, (vi) risks related to Omnicell’s investments in new business strategies or initiatives, including its transition to selling more products and services on a subscription basis, and its ability to acquire companies, businesses, or technologies and successfully integrate such acquisitions, (vii) risks related to failing to maintain expected service levels when providing our SaaS and Expert Services or retaining our SaaS and Expert Services customers, (viii) Omnicell’s ability to meet the demands of, or maintain relationships with, its institutional, retail, and specialty pharmacy customers, (ix) risks related to climate change, legal, regulatory or market measures to address climate change and related emphasis on ESG matters by various stakeholders, (x) changes to the 340B Program, (xi) risks related to the incorporation of artificial intelligence technologies, including generative or agentic AI technologies, into our products, services and processes or our vendors offerings, (xii) Omnicell’s substantial debt, which could impair its financial flexibility and access to capital, (xiii) covenants in our credit agreement could restrict our business and operations, (xiv) continued and increased competition from current and future competitors in the medication management automation solutions market and the medication adherence solutions market, (xv) risks presented by government regulations, legislative changes, fraud and anti-kickback statues, products liability claims, the outcome of legal proceedings, and other legal obligations related to healthcare, privacy, data protection, and information security, and the costs of compliance with, and potential liability associated with, our actual or perceived failure to comply with such obligations, including any potential governmental investigations and enforcement actions, litigation, fines and penalties, exposure to indemnification obligations or other liabilities, and adverse publicity related to the same; (xvi) any disruption in Omnicell’s information technology systems and breaches of data security or cyber-attacks on its systems or solutions, including the previously disclosed ransomware incident and any potential adverse legal, reputational, and financial effects that may result from it and/or additional cybersecurity incidents, as well as the effectiveness of business continuity plans during any future cybersecurity incidents, (xvii) risks associated with operating in foreign countries, (xviii) Omnicell’s ability to recruit and retain skilled and motivated personnel, (xix) Omnicell’s ability to protect its intellectual property, (xx) risks related to the availability and sources of raw materials and components or price fluctuations, shortages, or interruptions of supply, (xxi) Omnicell’s dependence on a limited number of suppliers for certain components, equipment, and raw materials, as well as technologies provided by third-party vendors, (xxii) fluctuations in quarterly and annual operating results may make our future operating results difficult to predict, (xxiii) failing to meet (or significantly exceeding) our publicly announced financial guidance, and (xxiv) other risks and uncertainties further described in the “Risk Factors” section of Omnicell’s most recent Annual Report on Form 10-K, as well as in Omnicell’s other reports filed with or furnished to the United States Securities and Exchange Commission (“SEC”), available at www.sec.gov. Forward-looking statements should be considered in light of these risks and uncertainties. Readers are encouraged to review this press release in conjunction with our most recent Annual Report on Form 10-K and our other reports filed with or furnished to the SEC. Investors and others are cautioned not to place undue reliance on forward-looking statements. All forward-looking statements contained in this press release speak only as of the date of this press release. Omnicell assumes no obligation to update any such statements publicly, or to update the reasons actual results could differ materially from those expressed or implied in any forward-looking statements, whether as a result of changed circumstances, new information, future events, or otherwise, except as required by law.

Use of Non-GAAP Financial Information

This press release contains financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). Management evaluates and makes operating decisions using various performance measures. In addition to Omnicell’s GAAP results, we also consider non-GAAP product gross profit, non-GAAP product gross margin, non-GAAP service gross profit, non-GAAP service gross margin, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating expenses, non-GAAP income from operations, non-GAAP operating margin, non-GAAP net income, non-GAAP net income per diluted share, non-GAAP diluted shares, non-GAAP EBITDA, non-GAAP EBITDA margin, and non-GAAP free cash flow. These non-GAAP results and metrics should not be considered as an alternative to revenues, product gross profit, service gross profit, gross profit, operating expenses, income from operations, net income, net income per diluted share, diluted shares, net cash provided by operating activities, or any other performance measure derived in accordance with GAAP. We present these non-GAAP results and metrics because management considers them to be important supplemental measures of Omnicell’s performance and refers to such measures when analyzing Omnicell’s strategy and operations.

Our non-GAAP product gross profit, non-GAAP product gross margin, non-GAAP service gross profit, non-GAAP service gross margin, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating expenses, non-GAAP income from operations, non-GAAP operating margin, non-GAAP net income, non-GAAP net income per diluted share, non-GAAP EBITDA, and non-GAAP EBITDA margin are exclusive of certain items to facilitate management’s review of the comparability of Omnicell’s core operating results on a period-to-period basis because such items are not related to Omnicell’s ongoing core operating results as viewed by management. We define our “core operating results” as those revenues recorded in a particular period and the expenses incurred within such period that directly drive operating income in such period. Management uses these non-GAAP financial measures in making operating decisions because, in addition to meaningful supplemental information regarding operating performance, the measures give us a better understanding of how we believe we should invest in research and development, fund infrastructure growth, and evaluate the effectiveness of marketing strategies. In calculating the above non-GAAP results: non-GAAP product gross profit and non-GAAP product gross margin exclude from their GAAP equivalents items a), b), and f) below; non-GAAP service gross profit, non-GAAP service gross margin, non-GAAP gross profit and non-GAAP gross margin exclude from their GAAP equivalents items a), b), e), and f) below; non-GAAP operating expenses, non-GAAP income from operations and non-GAAP operating margin exclude from their GAAP equivalents items a), b), c), e), f), g), h), and i) below; and non-GAAP net income and non-GAAP net income per diluted share exclude from their GAAP equivalents items a) through j) below.

Contacts

Kathleen Nemeth

Senior Vice President, Investor Relations

650-435-3318

Kathleen.Nemeth@Omnicell.com

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