C2N Diagnostics Expands the PrecivityAD2™ Alzheimer’s Disease Blood Test Intended Use to Patients 50 Years and Older




C2N Diagnostics Expands the PrecivityAD2™ Alzheimer’s Disease Blood Test Intended Use to Patients 50 Years and Older

Lower Age Limit Addresses Increasing Calls from Clinicians Seeking Access to the PrecivityAD2™ Test for Patients With Earlier Onset of Cognitive Symptoms;

Test Provides Potential to Inform Earlier Intervention

ST. LOUIS–(BUSINESS WIRE)–#Alzheimers–Clinicians worried about early-onset Alzheimer’s disease in patients with cognitive concerns between the ages of 50 and 55 years can now prescribe the PrecivityAD2™ blood test to aid in the diagnosis of the neurological disorder for that expanded population. The test helps healthcare professionals in the detection of amyloid plaques in the brain, a pathological hallmark of Alzheimer’s disease, and helps inform medical management and treatment decisions.

C2N Diagnostics introduced the PrecivityAD2 blood tests two years ago for patients 60 years and older. C2N has now completed additional validation to lower the age limit to 50 and older (meaning those born in 1975 and before).

Alzheimer’s Disease International reports that 75% all dementia cases go undiagnosed across the globe, with the figure rising to 90% in developing countries. C2N believes the expansion of the age range for the PrecivityAD2 test can play a role in reducing these high numbers.

The Journal of the American Medical Association (JAMA) published a large clinical study examining the ability of the PrecivityAD2™ blood test to improve the diagnostic accuracy of Alzheimer’s disease in primary care settings, where most patients with cognitive concerns turn to for initial answers about their memory loss. The study found similar robustness for the PrecivityAD2 test in patients who saw memory care specialists. The PrecivityAD2 test delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis.

The article, “Blood Biomarkers to Detect Alzheimer’s Disease in Primary Care and Secondary Care,” also states that these results involving over 1,200 patients were substantiated despite a relatively high rate of medical comorbidities such as cardiovascular disease, high cholesterol, chronic kidney disease, and diabetes among prospectively enrolled patients in both primary and secondary care. The paper further demonstrated the test’s effectiveness for those between the ages of 50 and 55. Further insights about Precivity’s clinical validity and performance are available on its website.

C2N CEO Dr. Joel Braunstein says, “We’ve been working diligently to meet the need for easy, accessible, and affordable blood tests for those patients and families who want answers in their early 50s, and we’re proud we’ve reached this milestone. We recognize that patients with mild cognitive impairment due to Alzheimer’s disease are very eager to access the new disease-modifying therapies, and scientists have stated these therapies are most successful when they start early. C2N believes it’s uniquely positioned, more than ever, to support the medical community in confirming Alzheimer’s disease pathology with its PrecivityAD2 test.”

Dr. Braunstein also says that C2N technology was used in the clinical trials of some of the latest therapies now available to patients with early Alzheimer’s disease.

In addition, the revised PrecivityAD2 intended use to allow for testing in patients 50 and older has been incorporated into the MHRA Medical Device Certification in the United Kingdom, which C2N announced earlier this year.

Precivity Test Availability and Quality Standards

The Precivity tests are available in 49 states in the U.S., excluding New York (where certification is pending), as well as the District of Columbia and Puerto Rico. C2N also recently signed additional global partners to broaden access in Asia, Latin America, Europe and the Middle East.

C2N’s Precivity tests for patient care are performed under the ISO 13485:2016 standard and in the company’s CAP accredited, CLIA certified laboratory.

About C2N Diagnostics, LLC

C2N is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health.

C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health.

C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums in addition to research and distribution partnerships with leading labs around the world including Grupo Fleury, Healius, Mediford, Unilabs, and Mayo Clinic Laboratories. Over 50,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review.

The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, BrightFocus Foundation, and Alzheimer’s Association. For more information visit www.c2n.com.

Contacts

COMPANY CONTACT:

Joni Henderson

info@C2N.com

MEDIA CONTACT:

Adam Shapiro

Adam.Shapiro@ASPR.bz
202-427-3603

US Narcolepsy Drugs Market Outlook and Company Analysis Report 2025-2033 Featuring Jazz Pharma, Ligand Pharma, Novartis, Takeda Pharma, Teva, Hikma, Harmony Biosciences, Roche – ResearchAndMarkets.com




US Narcolepsy Drugs Market Outlook and Company Analysis Report 2025-2033 Featuring Jazz Pharma, Ligand Pharma, Novartis, Takeda Pharma, Teva, Hikma, Harmony Biosciences, Roche – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “United States Narcolepsy Drugs Market to Reach US$ 2,233.56 Million by 2033 – 7.88% CAGR Driven by Novel Therapies and Better Diagnosis” report has been added to ResearchAndMarkets.com’s offering.

The United States Narcolepsy Drugs Market is expected to reach US$ 2.23 billion by 2033 from US$ 1.12 billion in 2024, with a CAGR of 7.88% from 2025 to 2033. The market is expanding mainly due to the growing prevalence of sleep disorders, improved knowledge and diagnosis of narcolepsy, continuous improvements in medication development, and a supportive regulatory environment.

United States Narcolepsy Drugs Market Overview

The market for narcolepsy medications in the US is expanding steadily due to rising awareness, better diagnostic rates, and continuous developments in treatments for sleep disorders. Between 135,000 and 200,000 Americans suffer from narcolepsy, a chronic neurological disorder that affects the brain’s ability to control sleep-wake cycles.

A growing need for efficient symptom management is driving the market, and drugs like pitolisant, sodium oxybate, armodafinil, and modafinil are essential. In order to improve treatment compliance and efficacy, the U.S. Food and Drug Administration (FDA) keeps approving new formulations and extended-release medications. Clinical trial enrollment and public awareness of the illness have also improved as a result of greater research funding and patient activism.

In many areas, the prevalence of sleep disorders, including narcolepsy, is generally rising. For example, a Narcolepsy Network article states that approximately one in every 2,000 Americans suffers from narcolepsy. This amounts to about 200,000 Americans and approximately 3 million people worldwide.

A growing number of sleep problems are caused by lifestyle variables such as increasing stress, inconsistent sleep habits, and the rise in late-night technology use. The need for narcolepsy treatments is growing as more people look for solutions to their sleep problems. In the upcoming years, these factors are anticipated to drive the expansion of the narcolepsy medication market.

Leading pharmaceutical firms leading the way in product research and commercialization include Harmony Biosciences, Avadel Pharmaceuticals, and Jazz Pharmaceuticals. Particularly for the treatment of cataplexy and excessive daytime sleepiness, Jazz’s Xyrem and Xywav continue to lead the market.

However, the introduction of novel therapies and generic competition are changing the market dynamics. By providing more convenient dosing and fewer side effects, the introduction of once-nightly sodium oxybate and orexin receptor agonists has the potential to completely change therapy paradigms.

High medication costs and restricted access to specialists continue to be major obstacles in spite of these developments. However, with robust regulatory support and an increasing emphasis on enhancing the quality of life for narcolepsy patients, the U.S. narcolepsy medication market is well-positioned for further innovation.

Key Factors Driving the United States Narcolepsy Drugs Market Growth

Enhanced Awareness and Diagnosis

• Early detection and precise diagnosis of narcolepsy have been greatly aided by the past ten years’ increase in clinical and public awareness of the disorder.
• Broader media coverage and educational campaigns spearheaded by patient advocacy organizations like the Narcolepsy Network have contributed to a decrease in stigma and a greater awareness of the symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy.
• The time between symptom onset and diagnosis has decreased as a result of improved training for clinicians to identify the signs. Patient outcomes and quality of life are enhanced by earlier diagnosis, which enables more prompt management.
• More people are seeking medical attention as a result of this increased knowledge, which is fueling the need for efficient treatment choices in the US.

Developments in Diagnostic Tools

• The precision of narcolepsy diagnosis has increased due to technological developments in sleep medicine.
• Nowadays, sleep clinics all across the United States have access to tools like polysomnography (PSG) and the Multiple Sleep Latency Test (MSLT), which allow clinicians to quantify sleep patterns, REM onset, and sleep latency – all important markers of narcolepsy – objectively.
• These tests are assisting medical professionals in differentiating narcolepsy from other sleep disorders such as insomnia or sleep apnea, in conjunction with enhanced clinical guidelines and diagnostic criteria.
• As a result, more patients are getting the right care, and misdiagnosis rates have dropped.
• In addition to expediting the patient journey, improved diagnostic capabilities are driving market expansion by increasing the number of diagnosed patients in need of medication.

Launch of Novel Therapies

• The launch of novel therapies that cater to unmet clinical needs is drastically altering the market for narcolepsy medications in the United States.
• These days, novel medicines like once-nightly sodium oxybate and non-scheduled drugs like pitolisant are replacing or supplementing traditional stimulants and older formulations like twice-nightly sodium oxybate.
• These new medications provide better long-term adherence, fewer side effects, and more convenient dosage.
• Furthermore, there is promise for even more individualized treatment in the near future thanks to the development of orexin receptor agonists and other targeted medicines.
• In addition to improving patients’ quality of life, these developments set pharmaceutical products apart in a crowded market, promoting both clinical uptake and financial success.

Challenges in the United States Narcolepsy Drugs Market

Regulatory and Reimbursement Obstacles

• Although the FDA in the United States has taken action to encourage the development of orphan medications, such as those for uncommon ailments like narcolepsy, market access is still extremely difficult because of reimbursement obstacles.
• The cost of many narcolepsy treatments is considerable, including those based on sodium oxybate and more recent medications like pitolisant.
• Before granting coverage, insurance companies frequently demand a lot of paperwork, prior permission, or step therapy procedures, which delays patients’ access to treatment.
• Both doctors and patients may become frustrated by these administrative obstacles, which may cause them to stop receiving therapy or avoid it entirely.
• Disparities in access are also brought about by variations in reimbursement practices between government programs and private insurers.
• Navigating reimbursement is a significant barrier to providing the best possible care, which is especially important in a market where prompt and ongoing therapy is necessary for symptom management and quality of life maintenance.

Stigma and Ignorance

• Despite advancements in public health education, the general public and even medical professionals continue to have a poor understanding of narcolepsy.
• Hallucinations, cataplexy, and excessive daytime sleepiness are some symptoms that are frequently confused with sadness, laziness, or other mental health conditions.
• Patients experience severe emotional distress and social humiliation as a result of this misperception.
• Furthermore, many primary care doctors are not familiar with the full clinical presentation of narcolepsy due to its rarity and complexity, which can result in incorrect diagnoses or delayed referrals to sleep specialists.
• Patients may experience significant effects on their education, careers, and interpersonal connections over the several years it takes on average to receive a diagnosis.
• This ignorance impacts research funding and policy attention in addition to impeding early detection and treatment.
• To improve outcomes for people with narcolepsy in the United States, it is imperative to address stigma and enhance clinical education.

Company Analysis: Overviews, Key Persons, Recent Developments, SWOT Analysis, Revenue Analysis

• Jazz Pharmaceuticals
• Ligand Pharmaceuticals
• Novartis AG
• Takeda Pharmaceutical
• Teva Pharmaceutical
• Hikma Pharmaceuticals Plc
• Harmony Biosciences Holdings
• Roche Holding AG
• Johnson & Johnson

Key Attributes:

Key Topics Covered:

1. Introduction

2. Research & Methodology

2.1 Data Source

2.1.1 Primary Sources

2.1.2 Secondary Sources

2.2 Research Approach

2.2.1 Top-Down Approach

2.2.2 Bottom-Up Approach

2.3 Forecast Projection Methodology

3. Executive Summary

4. Market Dynamics

4.1 Growth Drivers

4.2 Challenges

5. United States Narcolepsy Drugs Market

5.1 Historical Market Trends

5.2 Market Forecast

6. Market Share Analysis

6.1 By Disease Type

6.2 By Therapeutic Type

6.3 By End Users

6.4 By States

7. Disease Type

7.1 Daytime Extreme Sleepiness

7.2 Cataplexia

7.3 Other Disease Type

8. Therapeutic Type

8.1 Central Nervous Systems Stimulants

8.2 Tricyclic Antidepressants

8.3 Sodium Oxybate

8.4 Selective Serotonin Reuptake Inhibitor

8.5 Others

9. End Users

9.1 Diagnostics Centers

9.2 Hospitals

9.3 Others

10. Top 10 States

10.1 California

10.2 Texas

10.3 New York

10.4 Florida

10.5 Illinois

10.6 Pennsylvania

10.7 Ohio

10.8 Georgia

10.9 Washington

10.10 New Jersey

10.11 Rest of United States

11. Value Chain Analysis

12. Porter’s Five Forces Analysis

12.1 Bargaining Power of Buyers

12.2 Bargaining Power of Suppliers

12.3 Degree of Competition

12.4 Threat of New Entrants

12.5 Threat of Substitutes

13. SWOT Analysis

13.1 Strength

13.2 Weakness

13.3 Opportunity

13.4 Threats

14. Pricing Benchmark Analysis

14.1 Jazz Pharmaceuticals

14.2 Ligand Pharmaceuticals

14.3 Novartis AG

14.4 Takeda Pharmaceutical

14.5 Teva Pharmaceutical

14.6 Hikma Pharmaceuticals Plc

14.7 Harmony Biosciences Holdings

14.8 Roche Holding AG

14.9 Johnson & Johnson

15. Key Players Analysis

For more information about this report visit https://www.researchandmarkets.com/r/phpu4s

About ResearchAndMarkets.com

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

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Varian Completes Enrollment and Treatment in FAST-02 Clinical Trial of Flash Therapy in Treating Thoracic Bone Metastases




Varian Completes Enrollment and Treatment in FAST-02 Clinical Trial of Flash Therapy in Treating Thoracic Bone Metastases

• Flash ultra-high dose rate therapy enabled by Varian proton and planning technologies
• Collaboration between Varian and leading institutions drives progress toward next-generation cancer treatments
• Flash delivers treatment over 100 times faster than conventional radiation therapy

PALO ALTO, Calif.–(BUSINESS WIRE)–#varian–Varian, a Siemens Healthineers company, has announced the successful completion of enrollment and treatment in its FAST-02 (Flash Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax) clinical trial. The FAST-02 study targets painful bone metastases in the thoracic region and represents a significant step toward bringing this investigational radiotherapy treatment into clinical practice.

The trial was conducted at Cincinnati Children’s Hospital/UC Health Proton Therapy Center and enrolled 10 participants. It focused on evaluating treatment-related side effects and the efficacy of treatment, which was assessed using trial participants’ reported pain relief. FAST-02 builds upon findings from Varian’s FAST-01 trial, which evaluated clinical workflow feasibility of Flash therapy and treatment-related side effects for participants with bone metastases in the extremities. The trial is led by Principal Investigator John Perentesis, M.D., Professor and Director, Cancer and Blood Disease Institute, Cincinnati Children’s Hospital, and lead Co-Investigator Emily Daugherty, M.D., Associate Professor of Radiation Oncology, University of Cincinnati Cancer Center.

Flash therapy delivers treatment at ultra-high dose rates in typically less than one second – over 100 times faster than conventional radiation therapy—and has demonstrated potential in preclinical studies to reduce damage to surrounding healthy tissues while maintaining effective tumor control.

“Completing treatments for FAST-02 is a pivotal and progressive step in our effort to establish the safety and effectiveness of Flash radiotherapy,” said John Perentesis, M.D., Professor and Director, Cancer and Blood Disease Institute, Cincinnati Children’s Hospital Medical Center (CCHMC). “This trial helps lay the groundwork needed to move Flash into more advanced clinical settings—an innovation that could redefine radiation oncology and meaningfully improve patient outcomes.”

As part of the FAST-02 trial, Varian’s ProBeam proton therapy system was modified to enable ultra-high dose rate delivery for Flash treatments. In parallel, the Eclipse treatment planning system was enhanced to support planning for Flash therapy. Varian is advancing Flash therapy as an integrated system, encompassing planning, quality assurance, and treatment delivery technologies.

“The integration of treatment and planning represents a major technological achievement,” said Anthony Mascia, executive director and director of medical physics of the CCHMC Proton Therapy Center. “From a physics standpoint, we’re pushing the boundaries of both planning and delivering ultra-high dose rates, and we’re doing it safely.”

OSF HealthCare, a multi-site healthcare system with locations across Illinois and Michigan, collaborated in the trial and referred participants for enrollment.

James McGee, MD, founding director of the OSF Cancer Institute, stated: “We’re proud to have supported the FAST-02 trial. It is rewarding to contribute to research that further advances Flash therapy.”

Added Deepak “Dee” Khuntia, MD, senior vice president and chief medical officer at Varian: “This is an exciting time for radiation oncology; completing enrollment in FAST-02 underscores our commitment to develop the evidence needed to advance technologies that have the potential to transform the future of cancer care. We are proud to collaborate with institutions that share our vision for patient-centered innovation.”

Now that participant treatment is complete, data analysis of the results will inform future clinical studies and further evaluation of the potential of Flash therapy across broader treatment applications.

For information about the FAST-02 clinical trial, go to: Study Details | FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax | ClinicalTrials.gov

© 2025 VARIAN MEDICAL SYSTEMS, INC. All trademarks are the property of their respective owners.

CAUTION: The Flash-enabled ProBeam system is an investigational device and is limited by United States law for investigational use.

QR700027418

About Varian

At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help care providers around the globe treat millions of patients each year. Today, as a Siemens Healthineers company, we support every step of the cancer care journey – from screening to survivorship. From advanced imaging and radiation therapy to comprehensive software and services, to interventional radiology, we are harnessing the power of our perspective while also pursuing clinical research to create a more efficient, and more personalized care pathway. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com.

Contacts

Varian Press Contact

Kristin Corey

Varian Corporate Communications

Kristin.Corey@varian.com

Aditxt’s Subsidiary Adimune Highlights Its Approach to Reprogramming the Immune System Through DNA Instructions, Now with 96 Granted and 22 Pending Patents Targeting Autoimmunity Market Estimated at Over $160 Billion by 2030




Aditxt’s Subsidiary Adimune Highlights Its Approach to Reprogramming the Immune System Through DNA Instructions, Now with 96 Granted and 22 Pending Patents Targeting Autoimmunity Market Estimated at Over $160 Billion by 2030

Plans to seek FDA submission and approval for first-in-human trials in type 1 diabetes and stiff person syndrome targeted for early 2026

MOUNTAIN VIEW, Calif.–(BUSINESS WIRE)–Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt”, or the “Company”), a social innovation platform accelerating promising health innovations, today announced an update on its wholly owned subsidiary Adimune, Inc. (“Adimune”), which is pioneering a DNA-based therapeutic platform designed to reprogram the immune system. Adimune’s intellectual property portfolio now includes 96 granted and 22 pending patents that are owned or exclusively licensed by Aditxt, supporting the company’s strategy to address the global autoimmune therapeutics market, which is estimated at over $160 billion by 2030.

“We believe Adimune has the potential to represent a fundamental shift in how we think about the immune system and biology in general,” said Amro Albanna, Co-founder and Chief Executive Officer of Aditxt. “If successful in harnessing DNA instructions and a proprietary delivery platform to reprogram the immune system, Adimune has the potential to lead a new era of addressing diseases through programming instructions designed to create innovative treatments that have the potential to build significant long-term value. With a robust patent portfolio and a focus on a multi-billion-dollar global market, Adimune is central to our mission of making promising innovations possible.”

“Autoimmunity is one of the most complex and urgent challenges in medicine,” said Friedrich Kapp, Co-Chief Executive Officer of Adimune. “Our platform is designed to reprogram the immune system, restoring tolerance without the burden of chronic immunosuppression. By combining DNA instructions with our proprietary delivery platform, we are aiming for digital-like precision in how the immune system is retrained. With the first ADI product candidate ADI-100, we are targeting high-need conditions such as type 1 diabetes, psoriasis, and stiff person syndrome. Our plan to seek FDA submission and approval for first-in-human trials in early 2026 represents a critical milestone toward translating this vision into real solutions for patients.”

About Aditxt

Aditxt, Inc. is a social innovation platform accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model that democratizes innovation, ensures every stakeholder’s voice is heard and valued, and empowers collective progress. The Company currently operates two programs focused on immune health and precision health. Through the proposed acquisition of Evofem under the July 2024 Amended and Restated Merger Agreement between Evofem, Aditxt and Adifem, as amended (the “A&R Merger Agreement”), Aditxt aims to introduce an additional program dedicated to women’s health. The companies are working toward a targeted close in the second half of 2025. The closing of the transaction with Evofem is subject to several conditions, including but not limited to approval of the transaction by Evofem’s shareholders and Aditxt raising sufficient capital to fund its obligations at closing. These obligations include cash payments of approximately $17 million for Evofem, which includes approximately $15.0 million required to satisfy Evofem’s senior secured noteholder; should Aditxt fail to secure these funds, Evofem’s senior secured noteholder is expected to seek to prevent the closing of the merger with Evofem. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close.

About Adimune

Adimune is a pre-clinical stage biopharmaceutical company pioneering a new class of immune modulation therapies designed to restore natural immune tolerance. Our mission is to advance immune health by providing targeted, long-term solutions that minimize reliance on chronic immunosuppression—transforming treatment for autoimmune diseases and organ transplantation.

Forward-looking statements

This press release includes “forward-looking statements,” within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, “achieving,” “advancing”, “aim,” “are working to,” “believe,” “completing,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “suggest,” “strategy,” “target,” “will,” “would,” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to the merit of the patent applications and the potential benefits of such patents, if awarded; the size of the markets which Adimune is targeting; Adimune’s ability to commence in-human clinical trials for type 1 diabetes and stiff person syndrome; ADI-100’s potential to become a viable treatment option for autoimmune disease; Aditxt’s ability to successfully execute its mission to accelerate and monetize promising health innovations, and magnitude thereof. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in each company’s SEC filings, including Aditxt’s Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent Form 10-Q filings, including the most recent filed on August 14, 2025. All forward-looking statements are expressly qualified in their entirety by such factors. Aditxt undertakes no duty to update any forward-looking statement except as required by law.

Contacts

Aditxt, Inc.

Investor Relations

ir@aditxt.com

Merck Demonstrates Ongoing Commitment to Advancing Cardiovascular Disease Management and Patient Care with New Data at the European Society of Cardiology Congress 2025




Merck Demonstrates Ongoing Commitment to Advancing Cardiovascular Disease Management and Patient Care with New Data at the European Society of Cardiology Congress 2025

New real-world evidence and clinical trial data provide insights into treatment patterns for several serious cardiovascular diseases, including ASCVD, PH, and HFrEF

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that new clinical trial and outcomes research data will be presented at the European Society of Cardiology Congress (ESC) 2025 in Madrid, Spain from August 29 – September 1. Data presented at ESC include Merck’s latest research focusing on atherosclerotic cardiovascular disease (ASCVD), pulmonary hypertension (PH), and heart failure with reduced ejection fraction (HFrEF).

“Cardiovascular disease remains the leading cause of death worldwide, and Merck is committed to addressing this urgent public health challenge through research and innovative science,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “At this year’s congress, the data we are presenting reflect our continued commitment to advancing cardiovascular research with the goal of improving outcomes for patients at risk around the world.”

Merck will share two oral presentations focused on the treatment patterns and burdens for patients living with ASCVD. The first presentation evaluates the clinical and economic burden on patients with and without myocardial infarction using a nationwide 10-year registry; the second explores temporal trends in lipid-lowering therapy utilization in a large-scale patient population with ASCVD. These data demonstrate Merck’s commitment to advancing research focused on patients living with ASCVD and highlight opportunities for improved disease management in a real-world setting.

Key details on clinical trial research for WINREVAIR™ (sotatercept-csrk) in PH will be shared. The rationale and design of the Phase 2 study CADENCE in adults with combined post- and precapillary pulmonary hypertension (Cpc-PH) associated with heart failure with preserved ejection fraction (HFpEF) will be featured. Additionally, results from the ZENITH trial describing the effect of WINREVAIR on hemodynamics in high-risk pulmonary arterial hypertension (PAH) will also be presented.

Merck will also share two hot line oral presentations and two supplementary poster presentations evaluating VERQUVO^® (vericiguat) in adult patients with HFrEF from the VICTOR trial and a pooled-analysis of the VICTOR and VICTORIA trials, along with real-world analyses.

Details on Merck-sponsored symposia at ESC in Madrid:

Merck will host three symposia throughout the congress. A symposium on Sunday, August 31 from 9:15 – 10:00 a.m. ET/15:15 – 16:00 p.m. CEST (Room Yerevan, North Convention Center) will focus on how learnings from LDL-C cumulative exposure and ASCVD risk continuum perspective could impact clinical practice in hyperlipidemia management. The importance of early and lower LDL-C goal attainment in ASCVD to prevent CV outcomes will also be discussed. Other Merck-hosted symposia focus on treating PAH by reverse remodeling and RV function improvement (Sunday, August 31 from 9:15 – 10:00 a.m. ET/15:15 – 16:00 p.m. CEST in Room Algiers, Hall 7) and a patient advocacy event discussing barriers and challenges in CVD (Friday, August 29 from 4:00 – 4:45 a.m. ET/10:00 – 10:45 a.m. CEST in Room Nicosia, North Convention Center).

In addition to the three symposia, Merck is one of the sponsors of the ESC Cardiovascular Health Check, an opportunity for on-site attendees to participate in a free cardiovascular risk screening via comprehensive blood testing including total cholesterol, LDL-cholesterol, Lp(a), triglycerides, HbA1c as well as BMI, blood pressure and more.

Details on Merck abstracts at ESC:

Merck’s focus on cardiovascular disease

Merck has a long history of making an impact in cardiovascular disease. More than 60 years ago, we introduced our first cardiovascular therapy – and our scientific efforts to understand cardiovascular-related disorders have continued. Cardiovascular disease continues to be one of the most serious health challenges, and approximately 19 million people across the globe die every year.

At Merck, we strive for scientific excellence and innovation in all stages of research, from discovery through approval and life cycle management. We work with experts throughout the cardiovascular and pulmonary community to advance research that can help improve the lives of patients globally.

About atherosclerotic cardiovascular disease

Atherosclerotic cardiovascular disease (ASCVD) is a condition caused by the buildup of plaque within the arteries, leading to narrowed or blocked blood vessels that can result in serious cardiovascular events. ASCVD includes conditions such as coronary artery disease, peripheral artery disease, and cerebrovascular disease. It is a leading cause of death worldwide, contributing to the majority of heart attacks and strokes. Despite advances in prevention and treatment, ASCVD continues to pose a significant public health burden, underscoring the need for early identification, lifestyle modification, and medical management.

About WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg

WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1 PH) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.

WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

Selected Safety Information for WINREVAIR in the U.S.

WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.

WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm³. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required.

In clinical studies, serious bleeding (eg, gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or with low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding.

WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment.

Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility.

The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%).

Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.

About PAH

Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 90,000 people worldwide are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%.

About VERQUVO^® (vericiguat)

VERQUVO is an oral once daily stimulator of soluble guanylate cyclase (sGC), an important enzyme in the nitric oxide (NO) signaling pathway. When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. Heart failure is associated with impaired synthesis of NO and decreased activity of sGC, which may contribute to myocardial and vascular dysfunction. By directly stimulating sGC, independently of and synergistically with NO, VERQUVO augments levels of intracellular cGMP, leading to smooth muscle relaxation and vasodilation.

VERQUVO is FDA-approved to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for HF or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%.

Selected Safety Information for VERQUVO tablets (2.5 mg, 5 mg and 10 mg)

WARNING: EMBRYO-FETAL TOXICITY

Females of reproductive potential: Exclude pregnancy before the start of treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. Do not administer VERQUVO to a pregnant female because it may cause fetal harm.

VERQUVO is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. VERQUVO is contraindicated in pregnancy. Based on data from animal reproduction studies, VERQUVO may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment. Advise females of reproductive potential to use effective contraception during treatment with VERQUVO and for at least one month after the final dose.

In a clinical trial, the most commonly observed adverse events with VERQUVO vs placebo, occurring at a frequency greater than or equal to 5%, were hypotension (16% vs 15%) and anemia (10% vs 7%).

Concomitant use of VERQUVO with PDE-5 inhibitors is not recommended because of the potential for hypotension.

There are no data on the presence of VERQUVO in human milk, the effects on the breastfed infant, or effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from VERQUVO, advise women not to breastfeed during treatment with VERQUVO.

About Heart Failure with Reduced Ejection Fraction

Heart failure with reduced ejection fraction (HFrEF), formerly known as systolic heart failure, is characterized by the compromised ability of the heart to pump blood sufficiently during its contraction phase. In the U.S., approximately 6.2 million adults (20 years of age and older) have heart failure, and approximately 50% of heart failure patients have HFrEF. An observational, cohort analysis of PINNACLE registry data showed that approximately half of patients with worsening chronic HFrEF are rehospitalized within 30 days of a worsening event, and an estimated one in five patients with worsening chronic HFrEF will die within two years.

About the Worldwide Collaboration Between Bayer and Merck

Since October 2014, Bayer and Merck (known as MSD outside of the United States and Canada) have pursued a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and Merck. Merck has the commercial rights to vericiguat in the U.S. and Bayer has the exclusive commercial rights in the rest of world. The companies share equally the costs of the development of vericiguat.

About Merck

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

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

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

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

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for WINREVAIR (sotatercept-csrk) at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_pi.pdf, Patient Information for WINREVAIR at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ppi.pdf, and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at https://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ifu_1-vial_2-vial_kits.pdf.

Please see Prescribing Information, including Boxed Warning, for VERQUVO (vericiguat) at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_pi.pdf and Medication Guide at https://www.merck.com/product/usa/pi_circulars/v/verquvo/verquvo_mg.pdf.

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Elizabeth Sell

(484) 698-9978

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

BeOne Medicines Announces IMDELLTRA Royalty Purchase Agreement for up to $950 Million




BeOne Medicines Announces IMDELLTRA Royalty Purchase Agreement for up to $950 Million

• Royalty Pharma to acquire rights to BeOne’s royalties on IMDELLTRA® (tarlatamab-dlle) worldwide (ex-China) sales for up to $950 million
• IMDELLTRA is a first-in-class DLL-3 targeting bispecific T-cell engager, indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne—BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced it has entered into an agreement to sell its royalty rights on the worldwide sales, excluding China, of Amgen’s IMDELLTRA® (tarlatamab-dlle) for up to $950 million to Royalty Pharma (Nasdaq: RPRX).

Under the terms of the agreement, BeOne will receive an upfront payment of $885 million, with the option to sell remaining royalties within 12 months for up to $65 million. BeOne will share in a portion of the royalty on annual sales above $1.5 billion, and will maintain royalty and all other rights to other assets under the terms of the existing collaboration with Amgen, including xaluritamig, a first-in-class STEAP1 x CD3 XmAb currently being studied in patients with metastatic castration-resistant prostate cancer (mCRPC).

IMDELLTRA is a first-in-class immunotherapy that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing cells. IMDELLTRA is approved in the United States for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after receiving platinum-based chemotherapy.

“Today’s announcement is testament to the value of our long-term collaboration with Amgen, the developer of IMDELLTRA, who recognized the potential of BeOne in advancing their oncology pipeline,” said John V. Oyler, Co-Founder, Chairman and CEO of BeOne. “In the five years since entering into this collaboration, we have executed with purpose in advancing our mission to deliver multiple transformative medicines to more patients worldwide.”

“This agreement meaningfully accelerates value realization for BeOne, while preserving continued participation in the long-term potential of IMDELLTRA,” said Aaron Rosenberg, Chief Financial Officer, BeOne. “A strong balance sheet is a hallmark of the most successful companies in our industry, and this transaction provides increased operational and strategic flexibility as we continue to execute our business strategy for the long term.”

About IMDELLTRA® (tarlatamab-dlle)

IMDELLTRA is a first-in-class immunotherapy that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell. DLL3 is a protein that is expressed on the surface of SCLC cells in the vast majority of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.

Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study evaluating tarlatamab in combination with standard of care therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 trial comparing tarlatamab monotherapy with standard of care chemotherapy in second-line treatment of ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 trial of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second line or later ES-SCLC; and DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding: the total amount of proceeds that BeOne will receive from the sale of IMDELLTRA royalty rights; the exercise of BeOne’s option to sell the remaining IMDELLTRA royalty rights; the benefits of the transaction; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom site.

Contacts

Investor Contact
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact
Navneet Miller

+1 857-301-6440

media@beonemed.com

Spotlight Medical Announces Publication in Journal of Clinical Oncology Validating AI Pathology Assay That Identifies Low-Risk Subgroup Within Clinically High-Risk Early ER+/HER2- Breast Cancer




Spotlight Medical Announces Publication in Journal of Clinical Oncology Validating AI Pathology Assay That Identifies Low-Risk Subgroup Within Clinically High-Risk Early ER+/HER2- Breast Cancer

The assay identifies a biologically low-risk subgroup within clinically high-risk patients, with outcomes similar to stage I disease, potentially sparing 30,000 women each year from unnecessary treatment intensification.

PARIS–(BUSINESS WIRE)–Spotlight Medical today announced that the Journal of Clinical Oncology has published a peer-reviewed study describing a clinicopathologic assay that identifies a sizeable subgroup of patients labelled clinical high risk (ER-positive, HER2-negative early breast cancer) who have a favourable long term prognosis after standard chemo-endocrine therapy alone. The study reports blinded validation on two prospective cohorts from the CANTO and UNIRAD trials.

Unmet need. Current guidelines recommend adjuvant escalation with CDK4/6 inhibitors for clinically high-risk ER+/HER2− disease, yet no routinely available tool reliably distinguishes patients who may do well with endocrine therapy plus chemotherapy alone. The newly published work addresses this clinical gap by combining routine clinical variables with human-interpretable morphology descriptors derived from a single H&E slide. The model integrates 4 clinicopathologic variables and 10 quantitative digital pathology descriptors.

“Escalating therapy for every clinically defined high-risk case exposes many women to toxicity without benefit. This assay provides actionable insight that lets us target treatment where it truly helps, potentially sparing 30,000 women each year from unnecessary toxicity,” said Prof. Fabrice André, MD, PhD, Chief Scientific Officer of Gustave Roussy.

Key results (prespecified, blinded validation). On the combined CANTO+UNIRAD validation cohorts (n = 633), the assay classified about one in five patients as low-risk; 95.4% of these remained free of distant relapse at 9 years, a 79% relative reduction in metastatic events compared to the remaining patients (sHR 0.21; p < 0.001).

Context. The 9-year freedom from distant recurrence in this low-risk subgroup is comparable to outcomes reported in TAILORx for node-negative, intermediate-risk patients treated with endocrine therapy alone (≈94.5%), for whom escalation was not considered beneficial.

How it works. The fully locked model uses routinely collected clinicopathologic inputs and quantitative, human-interpretable morphology from a single H&E slide; multivariable analyses in the paper indicate the assay provides independent prognostic information beyond standard factors. Analytical validation showed 96–100% reproducibility across tumor heterogeneity, scanners, and lab protocols, enabling robust deployment in multicenter settings.

“Our study shows that routine tumor slides contain new, robust, and clinically meaningful prognostic signals that can be extracted with transparent quantitative methods,” said Marvin Lerousseau, PhD, Chief Scientific Officer at Spotlight Medical. “The major strength of this work lies in demonstrating a fully locked assay validated under blinded conditions in two prospective trials, with results that were consistent across distinct patient populations.”

Article details

Title: “Identifying patients with low relapse rate despite high-risk ER +/ HER2- early breast cancer: development and validation of a clinicopathological assay”

Journal: Journal of Clinical Oncology (online 25 August 2025). Read the article here

***

About Spotlight Medical

Spotlight Medical is a French oncology diagnostics company developing evidence-driven, clinical-grade AI assays to support more precise treatment selection in cancer. The company’s science-first approach emphasises rigorous clinical validation and transparent algorithms that extend pathology expertise.

For more information, visit spotlightmedical.com and follow Spotlight Medical on LinkedIn.

Contacts

For media enquiries: press@spotlightmedical.com

MAARC – Press Relations

Bruno Arabian / +33 6 87 88 47 26 / bruno.arabian@maarc.fr
Nicolas Entz / +33 6 33 67 31 54 / nicolas.entz@maarc.fr

Abcuro Appoints George Eldridge as Chief Financial Officer




Abcuro Appoints George Eldridge as Chief Financial Officer

• Company further strengthens leadership team, with Mr. Eldridge bringing over 30 years of finance experience across biotechnology industry

NEWTON, Mass.–(BUSINESS WIRE)–Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, today announced the appointment of George Eldridge as Chief Financial Officer (CFO). Mr. Eldridge brings more than 30 years of executive leadership experience in finance and business operations across the biotechnology industry.

“George brings industry-leading financial expertise that will be essential to Abcuro as we prepare for a pivotal clinical data readout for our lead asset, ulviprubart,” said Alex Martin, Chief Executive Officer. “We are delighted to further strengthen our leadership team with George’s appointment and look forward to working with him and build on our strong financial position to advance ulviprubart.”

Mr. Eldridge has more than three decades of experience fundraising, taking companies public, facilitating mergers and acquisitions, and establishing critical financial operations throughout his career. He most recently served as CFO of Aerovate Therapeutics, notably guiding the company though its successful initial public offering (IPO) in 2021 and subsequent reverse merger with Jade Biosciences in 2025. He has also previously served as CFO at Proteon Therapeutics, Targanta Therapeutics, Therion Biologics, Curis (formerly Ontogeny), and Boston Life Sciences. He has also worked as an independent consultant, providing counsel to many early-stage biotechnology companies. Mr. Eldridge holds a Master of Business Administration from the University of Chicago Booth School of Business and a Bachelor of Arts from Dartmouth College.

“I am honored to join Abcuro and look forward to working closely with the leadership team to deliver on our mission to develop potentially life-transforming treatments for patients with devastating diseases like IBM,” said Mr. Eldridge. “This is also a pivotal time for Abcuro, and we will continue to focus on execution as we approach key milestones including initial data readout from the ongoing MUSCLE study next year.”

About Ulviprubart

Ulviprubart (ABC008) is a first-in-class anti-KLRG1 antibody product candidate capable of selectively depleting highly cytotoxic T cells, while sparing naïve, regulatory and central memory T cells. Ulviprubart is designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia (T-LGLL). The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have each granted orphan drug designation to ulviprubart for the treatment of IBM. The FDA has also granted Fast Track designation for ulviprubart in IBM.

About Inclusion Body Myositis (IBM)

IBM is a rare and debilitating autoimmune disease in which highly cytotoxic T cells chronically attack muscle tissue leading to progressive weakness and limb muscle atrophy. People living with IBM progressively lose muscle function, including loss of grip, dexterity and mobility. There are currently no available disease-modifying treatment options and no cure for IBM. Based on published epidemiology literature, it is estimated that there are more than 50,000 people with IBM across the US and Europe.

About Abcuro

Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia.

For more information, visit us on LinkedIn and at abcuro.com.

Contacts

Matthew DeYoung

Investor Relations and Media

Argot Partners

abcuro@argotpartners.com

IMvigor011 Bladder Cancer Trial Achieves Positive Results, with Signatera™ Strongly Predicting Adjuvant Immunotherapy Benefit




IMvigor011 Bladder Cancer Trial Achieves Positive Results, with Signatera™ Strongly Predicting Adjuvant Immunotherapy Benefit

Topline results from the trial show that Signatera-positive patients treated with atezolizumab (Tecentriq®) had statistically significant and clinically meaningful improvements in disease-free survival and overall survival

IMvigor011 is the first prospective phase III study in muscle-invasive bladder cancer to read out that uses a personalized, ctDNA MRD*-guided approach

AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced positive topline results from the randomized, phase III IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The trial is sponsored by Genentech, a member of the Roche Group.

IMvigor011 utilizes the Signatera ctDNA test in patients with MIBC to detect molecular residual disease (MRD) in the bloodstream after surgery and predict who will benefit from adjuvant treatment with the cancer immunotherapy atezolizumab (Tecentriq®). Approximately 760 patients were enrolled in the surveillance phase of the trial and underwent serial Signatera testing for up to 12 months post surgery. Patients were randomized to treatment with atezolizumab or placebo if they tested Signatera-positive and remained free of cancer recurrence on imaging with treatment administered every 4 weeks for 12 cycles or up to one year. Patients who consistently tested Signatera-negative were not randomized to treatment but continued to be followed up with radiographic imaging and ctDNA MRD testing.

Topline results from IMvigor011 demonstrated a statistically significant and clinically meaningful improvement in disease-free survival and overall survival for Signatera-positive patients treated with atezolizumab. Natera expects trial data to be presented at an upcoming medical conference.

“The results of IMvigor011 are very significant, opening the door for a new treatment paradigm for bladder cancer patients who are positive for recurrence on a molecular level but have no evidence of disease on imaging,” said Professor Thomas Powles, MBBS, MRCP, M.D., lead principal investigator of the study; Barts Cancer Institute QMUL. “We look forward to presenting the positive results later this year.”

“Importantly, IMvigor011 could change how resectable bladder cancer is managed for the tens of thousands of patients diagnosed with MIBC each year,” said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera.

Natera will finalize its premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for the selection of patients with MIBC to be treated with atezolizumab after cystectomy.

In addition to the topline result released today, a preliminary analysis of Signatera-negative patients from IMvigor011 was presented at the European Association of Urology in April 2024. The data highlighted that post-operative patients who remain Signatera-negative on serial testing had excellent outcomes without adjuvant treatment. The analysis showed that 171 patients who remained Signatera-negative during the surveillance window had overall survival rates of 100% at 12 months and 98% at 18 months, and disease-free survival rates of 92% at 12 months and 88% at 18 months after surgery.

Notes

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

*ctDNA MRD = circulating tumor DNA molecular residual disease

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

LEO Pharma Delivers 7% Revenue Growth at CER in H1 2025 and Achieves Key Milestones Enabling Future Growth




LEO Pharma Delivers 7% Revenue Growth at CER in H1 2025 and Achieves Key Milestones Enabling Future Growth

BALLERUP, Denmark–(BUSINESS WIRE)–In H1 2025, LEO Pharma delivered robust growth and significantly improved profitability, enabling an increase to the financial outlook for sales growth and adjusted EBITDA margin in 2025 towards the upper-end of previously communicated expectations. In July, the FDA approval of Anzupgo® and partnership with Boehringer Ingelheim for SPEVIGO®, marked major strategic milestones demonstrating LEO Pharma’s commitment to advancing innovation in dermatology.

Highlights

• LEO Pharma’s revenue increased by 6% year-on-year to DKK 6,789 million, and by 7% at constant exchange rates (CER) entirely driven by organic growth. The revenue growth was led by North America (+28% at CER), with Europe (+1% at CER) and Rest of World (+4% at CER) also contributing to the overall growth.
• Revenue from the Dermatology portfolio grew by 8% (CER) year-on-year, driven by the Strategic brands Adtralza^®/Adbry^® and Anzupgo^®, which combined had a revenue increase of 51% (CER). Sales in the Critical Care portfolio (formerly called ‘Thrombosis’) declined by 3% (CER) year-on-year, affected by the reversal of sales discounts in the same period last year.
• Operating profit improved significantly, with adjusted EBITDA reaching DKK 1,456 million in H1 2025, reflecting a margin of 21% (H1 2024: 9%) excluding the STAT6 partnership upfront payment from Gilead received in January and other non-recurring items.
• Net profit for H1 2025 was DKK 1,977 million (H1 2024: negative DKK 761 million), including non-recurring items.
• Free cash flow was DKK 1,469 million for H1 2025 (H1 2024: negative DKK 779 million), and net interest-bearing debt was reduced to DKK 9,676 million (YE 2024: DKK 11,115 million). Excluding M&A, free cash flow was negative DKK 158 million driven by timing and non-recurring one-offs.
• On 23 July, LEO Pharma received FDA approval of Anzupgo® (delgocitinib) for the treatment of chronic hand eczema, enabling launch of the product in the U.S. by Q3 2025 as the first and only topical pan-JAK inhibitor. Additionally, LEO Pharma on 9 July announced positive interim results from the phase 3 ADHAND trial for Adtralza®/Adbry® (tralokinumab).
• On 14 July, LEO Pharma announced a partnership with Boehringer Ingelheim, granting LEO Pharma an exclusive global license for the development and commercialization of SPEVIGO® (spesolimab), a first-in-class IL-36R antagonist already approved and marketed for generalized pustular psoriasis (GPP). The partnership aims to accelerate and broaden access for patients by leveraging LEO Pharma’s global dermatology platform. The transaction is expected to close in H2 2025 with SPEVIGO® set to become the third Strategic brand in LEO Pharma’s portfolio, alongside Adtralza®/Adbry® and Anzupgo®.
• For the 2025 outlook, group revenue growth is now expected to be 7-9% at CER (previously: 6-9%) and the adjusted EBITDA margin is now expected to be 16-18% (previously: 15-18%). This reflects the FDA approval of Anzupgo® and year-to-date business performance. The outlook does not include any impact from the partnership for SPEVIGO®, pending closing of the transaction.

LEO Pharma is in its strongest position in years – financially, strategically, and in terms of our portfolio and pipeline activities. The FDA approval of Anzupgo® represents a major step forward, and together with the addition of SPEVIGO® to our portfolio, we are further unlocking the value of our global platform, highlighting our commitment to driving innovation for patients.”

CEO Christophe Bourdon.

About LEO Pharma

LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Head-quartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com.

Contacts

For further information please contact:


Investor Relations:
Christian Sørup Ryom, telephone +45 4494 5888

Media:
Jeppe Ilkjær, telephone +45 3050 2014