Lumaegis Secures $200,000 in Pre-Seed Funding to Accelerate FDA De Novo Certification—Propelling Its Breakthrough Sterilization Technology Toward Market Readiness




Lumaegis Secures $200,000 in Pre-Seed Funding to Accelerate FDA De Novo Certification—Propelling Its Breakthrough Sterilization Technology Toward Market Readiness

AUSTIN, Texas–(BUSINESS WIRE)–Lumaegis, Inc., an emerging leader in medical device innovation, was recently honored as one of the 2024 RadLaunch Challenge Winners by the International Ultraviolet Association, recognizing its groundbreaking contributions to solid-state lighting-based sterilization technologies.

Lumaegis has also successfully closed a $200,000 pre-seed funding round, led by one of their global strategic partners. Lumaegis will use these funds to build the next set of production units and conduct FDA, UL/CE, and longevity testing.

At the heart of Lumaegis’ innovation is the RadBox, a patent-protected sterilization device designed as a fast, energy-efficient alternative to traditional sterilizers. The RadBox has received FDA De Novo classification, a designation reserved for breakthrough technologies with no existing, approved predicate device. This status highlights the RadBox’s significant advantages and its potential to improve patient outcomes, all the while saving the practitioners tens of thousands of dollars per year.

The company is set to begin FDA-required testing later this year. The RadBox utilizes dual-modality approach i.e., combination of germicidal and thermal radiation emitted by Light Emitting Diodes to achieve sterility. With key patent already granted and additional applications nearing completion, Lumaegis is preparing for commercial launch upon FDA De Novo approval.

“We anticipate our first sales in 2026,” said CEO John S. Morreale. “Production will begin that year, and we already have customers lined up. Many dental professionals who collaborated with us during the RadBox design phase will be among our first users, providing essential clinical feedback. Additionally, we’ve secured our first major customer — a global industry partner and investor in the disinfection and sterilization space — representing over 2,000 units in initial sales.”

Lumaegis is poised to redefine sterilization standards across dental and medical practices, offering a transformative solution that combines speed, efficiency, and safety, all the while reducing practitioners’ costs and improving their productivity.

About:

Lumaegis is headquartered in Austin, TX and is a member of University of Texas’ Austin Technology Incubator. Its mission is to support global health security and to reduce the environmental impact of sterilization processes globally. The founders are seasoned serial entrepreneurs with a proven track record of leveraging technology to address sustainability challenges.

Contacts

John S. Morreale

sterilize@lumaegis.com

LeafWorks Launches Industry-First DNA Quantification Test for Mushroom Blends and Beyond




LeafWorks Launches Industry-First DNA Quantification Test for Mushroom Blends and Beyond

New Test Delivers DNA Quantification, Filling a Critical Gap in Botanical and Functional Mushroom Testing

SEBASTOPOL, Calif.–(BUSINESS WIRE)–LeafWorks, a pioneering botanical genomics and testing company for natural products, today announced the immediate availability of DNA-based Quantification Testing for botanicals, starting with a focus on mushroom blends, a purpose-built assay that measures the composition of multi-species functional mushroom products.

Functional mushroom blends are gaining popularity, driving one of the fastest-growing categories in the natural products industry. Booming consumer demand has heightened the call for transparency, expanding pressure on manufacturers to confirm ingredient integrity amid complex supply chains.

LeafWorks’ Ingredient Quantification Testing provides quality control and quality assurance teams, sourcing managers and formulators the ability to validate ingredient composition with confidence—meeting 21 CFR 111 requirements, protecting against costly recalls and strengthening consumer trust.

Verifying mushroom blends can be a major challenge in processed materials—especially when using microscopy or when working with species of overlapping and/or variable metabolic profiles. LeafWorks’ DNA-based approach fills gaps with quantification that stands up to scientific and regulatory scrutiny.

“We’ve been hearing for years that brands struggle to verify what’s in their mushroom blends,” said Eleanor Kuntz, Ph.D., CEO of LeafWorks. “Now, with this new DNA-based quantification option, we’re giving them a tool that cuts through the noise. No guesswork. No ambiguity.”

To serve a wide range of industry needs, LeafWorks’ Ingredient Quantification Testing supports:

• Accuracy: This test uses validated, species-specific markers.
• QA/QC and product integrity checks: Confirm ingredient makeup against specifications.
• Regulatory compliance: Meet 21 CFR 111 label verification requirements with third-party validated results.
• Supplier validation and purchasing confidence: Audit claims in global supply chains with scientific precision.
• Product development and R&D: Monitor blend consistency, guide formulation improvements and ensure purity.
• Mycelium products: Quantify percent mushroom versus percent substrate with accuracy.
• Affordable, rapid tests built to AOAC International standards

What sets LeafWorks apart is its reliance on species-specific DNA regions rather than universal barcodes, which are prone to false positives and negatives, and its use of qPCR to perform highly sensitive quantification. And—critically for mycelium products—this test can distinguish percent substrate versus percent mushroom, delivering a clear picture of product composition.

This rigorous design ensures accuracy even in complex blends, where mushrooms may share overlapping chemistry profiles or appear visually similar.

“This is a major step forward for the industry,” said Nick Batora, Managing Director and Head of R&D at LeafWorks. “Chemistry can show you that certain metabolites are present in a blend, but it can’t always tell you which species they came from. Many plants and mushrooms share overlapping chemistries, and metabolite profiles can shift depending on things like tissue type, growing conditions or environment. With qPCR, we can go straight to the DNA and identify the source species with quantitative accuracy—whether it’s mushrooms or substrates like oats or grain.”

By filling a critical gap in the quantitative verification of blends, LeafWorks is giving sourcing managers, QA/QC professionals, and product developers actionable data to support compliance, protect brand reputation, and strengthen consumer trust.

“Variation in ingredient amounts can cause major risks for companies trying to meet their label claims in complex blend formulations,” said Kerin Law, Ph.D., LeafWorks’ Chief Scientific Officer. “Our Ingredient Quantification Test solves that immediately.”

The LeafWorks® Ingredient Quantification Test, starting in mushroom blends, is available immediately. For more information or to inquire about testing, visit leafworks.com or contact info@leafworks.com.

About LeafWorks

LeafWorks Inc. is a botanical genomics company conducting cutting-edge research and developing commercial DNA testing services for natural products. Co-founded by CEO Eleanor Kuntz, Ph.D., and CSO Kerin Law, Ph.D., the company combines scientific rigor with uncompromising ethics, specializing in DNA identification—from species ID down to trait detection—to protect and empower business operators. The company provides the necessary testing and services that help cultivators preserve their genetic IP, improve efficiency and ultimately evolve their operations. Learn more about LeafWorks Inc. at leafworks.com and connect on Facebook, Instagram, X and LinkedIn.

Contacts

Media Contact

Kerin Law

info@leafworks.com

Genentech and Roche Break Ground on State-of-the-Art Manufacturing Facility in Holly Springs, North Carolina




Genentech and Roche Break Ground on State-of-the-Art Manufacturing Facility in Holly Springs, North Carolina

– The $700 million project is part of Genentech and Roche’s $50 billion investment in U.S. manufacturing, infrastructure and R&D –

– The facility will create more than 1,900 jobs and support the production of next-generation metabolic medicines, including treatments for obesity –

– U.S. Rep. Deborah Ross, Gov. Josh Stein and other local leaders attended the groundbreaking event –

HOLLY SPRINGS, N.C.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today broke ground on its newest U.S. manufacturing site in Holly Springs, North Carolina. This significant development marks the establishment of Genentech’s first manufacturing facility on the East Coast. The 700,000-square-foot facility is strategically designed to support production of the company’s future portfolio of metabolic medicines, including next-generation treatments for obesity. The event was attended by federal, state and local officials, including U.S. Rep. Deborah Ross, North Carolina Gov. Josh Stein, State Sec. of Commerce Lee Lilley, State Sens. Sydney Batch and Lisa Grafstein, State Rep. Erin Paré, Wake County Commissioner Cheryl Stallings and Holly Springs Mayor Sean Mayefskie.

The project will add more than 400 local manufacturing jobs when the site is operational and more than 1,500 construction jobs during the development phase. Genentech’s initial investment in North Carolina is estimated at more than $700 million, part of a larger $50 billion commitment to President Trump’s initiatives to invest in U.S. manufacturing, infrastructure and R&D.

The company selected Holly Springs, a growing hub for biopharmaceutical innovation, for its highly skilled local workforce, strong academic institutions and proximity to other leading life science companies in the Raleigh-Durham area.

The new facility is expected to be completed and operational by 2029, incorporating modern biomanufacturing technologies, as well as advanced automation and digital capabilities. The future facility will increase production capacity for the company’s manufacturing network, while enhancing supply chain resilience through a high-volume, high-efficiency yet sustainable design. The 100-acre lot includes space for future expansion.

Genentech CEO Ashley Magargee:

“We are proud to break ground on our new manufacturing site in Holly Springs, North Carolina, with its world-class biotech talent, top research institutions and a robust infrastructure that will enable our growth for years to come. With this step, we are taking action to deliver more life-changing medicines to patients faster, contribute to the local economy, and bolster manufacturing and innovation in the U.S.,” Magargee said.

“We are supportive of President Trump’s goal to bring more pharmaceutical manufacturing to the United States and appreciate the work that Commerce Secretary Lutnick and the Department of Commerce’s U.S. Investment Accelerator are doing to remove regulatory barriers that cause delays in establishing manufacturing sites in the U.S. We also thank the North Carolina, Wake County and Holly Springs officials for their partnership. Their warm welcome and leadership in the life sciences bodes well for great things to come for our company, your communities, and, ultimately, for patients.”

U.S. Rep. Deborah Ross, 2nd North Carolina Congressional District:

“This groundbreaking is a milestone for our community and for North Carolina’s growing role in the biotech economy. Investments like this one mean good-paying jobs for our residents, expanded opportunities for workers with a range of skills and education, and continued growth for the Research Triangle’s innovation ecosystem. I look forward to working with Genentech to ensure this facility helps our region to thrive for decades to come.”

North Carolina Gov. Josh Stein:

“North Carolina has earned its reputation as the best state for business, and Genentech’s decision to put down roots in Holly Springs is further proof of our leadership in the biotech sector. From our top-tier research universities to our world-class workforce, North Carolina has exactly what companies need to succeed. I am pleased to welcome Genentech to Holly Springs as they expand their operations to the East Coast.”

Holly Springs Mayor Sean Mayefskie:

“The groundbreaking of Genentech’s new facility marks a defining step forward for Holly Springs. Not only does it strengthen Holly Springs’ role as a cornerstone in North Carolina’s life sciences manufacturing ecosystem, but we expect to see a powerful boost to our local economy, particularly for small businesses. We are thrilled for Genentech to be part of our community!”

About Genentech

Founded nearly 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.

Contacts

Media Contact: Shirley Dang, (650) 467-6800

Media Contact: Dean Mastrojohn, (650) 467-6800

Advocacy Contact: Danielle Haney, (240) 805-4810

Investor Contacts: Loren Kalm, (650) 225-3217

Apimeds Pharmaceuticals US, Inc. Partners with University of Alabama to Advance Biotech Business Development via ai² Future Labs




Apimeds Pharmaceuticals US, Inc. Partners with University of Alabama to Advance Biotech Business Development via ai² Future Labs

MATAWAN, N.J.–(BUSINESS WIRE)–Apimeds Pharmaceuticals US, Inc. (NYSE American: APUS) (“Apimeds”) today announced the launch of its ai² Future Labs program in partnership with The University of Alabama Culverhouse College of Business’s STEM Path to the MBA program. The initiative aims to identify important assets critical to improving human health and to cultivate the next generation of pharmaceutical industry business leaders.

Future Labs is part of Apimeds’ ai² innovation platform, connecting university students with real-world biopharmaceutical strategy and business development projects. Through this partnership, student teams will work closely with Apimeds mentors to identify and evaluate opportunities to advance development projects previously abandoned by industry.

“We’re excited to welcome The University of Alabama and their STEM Path to the MBA students to the Future Labs program,” said Erik Emerson, CEO of Apimeds. “UA will be the first of a select group of academic institutions we partner with to identify opportunities to improve patient care by reexamining promising projects. Drug development is complex, expensive, and time-consuming, which means many therapies with true potential never reach patients. Future Labs is designed to function as a discovery engine for products and future leaders – we look forward to working with University of Alabama and the students – Roll Tide – until you encounter #goducks.”

Students will gain hands-on experience in market analysis, FDA regulations, clinical development requirements, competitive positioning, intellectual property considerations, and commercialization planning—skills that extend far beyond the classroom. Top-performing teams at each participating institution will be eligible for paid internships or consulting opportunities with Apimeds, providing a direct pathway into the industry.

“We see this program as a way to uncover development opportunities while also giving students a practical look at the business side of biopharma,” said Brian Peters, SVP of the ai² Division at Apimeds Pharmaceuticals.

Rob Morgan, Ph.D., Director of the STEM Path and CREATE Path to the MBA programs at The University of Alabama, added: “Our students will gain unique experience contributing to the success of a biopharma company. This program provides a one-of-a-kind opportunity to bring the business of biotechnology to a new generation of leaders.”

The partnership underscores Apimeds’ commitment to fostering innovation, building industry–academic alliances, and developing the next generation of biotech leaders.

About Apimeds Pharmaceuticals

Apimeds Pharmaceuticals (NYSE American: APUS) is a clinical-stage biopharmaceutical company focused on developing non-opioid, biologic-based therapies for pain management. The company’s lead product candidate, Apitox, is in late-stage clinical development for osteoarthritis of the knee. For more information visit www.apimedsus.com. Information on the Apimeds’ website does not constitute a part of and is not incorporated by reference into this press release.

About Culverhouse College of Business and the STEM Path to the MBA Program

Established in 1919 by Lee Bidgood and currently led by Dean Kay Palan, the Culverhouse College of Business at The University of Alabama is a top-ranked leader in business education, offering bachelor’s, master’s, and doctoral degrees and has been accredited by AACSB since 1929.

Culverhouse launched the STEM Path to the MBA program in 2011, providing students from technical and scientific disciplines with unique exposure to business education throughout their undergraduate studies, culminating in the earning of an MBA with one additional year of study.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “anticipate”, “believe”, “expect”, “plan” and “will” are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, management. These statements relate only to events as of the date on which the statements are made, and Apimeds undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. All of the forward-looking statements made in this press release are qualified by these cautionary statements, and there can be no assurance that the actual results anticipated by Apimeds will be realized or, even if substantially realized, that they will have the expected consequences to or effects on the company or its business or operations. Readers are cautioned that certain important factors may affect Apimeds’ actual results and could cause such results to differ materially from any forward-looking statements that may be made in this press release. Factors that may affect Apimeds’ results include, but are not limited to, the ability of Apimeds to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to Apimeds’ ability to advance its product candidate and successfully complete clinical trials; risks relating to its ability to hire and retain qualified personnel; and the additional risk factors described in Apimeds’ filings with the U.S. Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2024 as filed with the SEC on April 15, 2025 (as amended on May 2, 2025).

Contacts

Media:
Brian Peters

Apimeds Pharmaceuticals

919-602-6557

jCyte Announces Publication of Phase I/IIa Safety Study of Retinal Progenitor Cells in Retinitis Pigmentosa in Frontiers in Cellular Neuroscience




jCyte Announces Publication of Phase I/IIa Safety Study of Retinal Progenitor Cells in Retinitis Pigmentosa in Frontiers in Cellular Neuroscience

IRVINE, Calif.–(BUSINESS WIRE)–jCyte, a clinical-stage biotechnology company developing transformative cell therapies for retinal diseases, today announced the publication “Retinal Progenitor Cells (jCell) for Retinitis Pigmentosa” containing results from its Phase I/IIa clinical trial evaluating the safety and tolerability of intravitreal injection of retinal progenitor cells (RPCs) in adults with non-syndromic retinitis pigmentosa (RP).

The prospective, multicenter, open-label, single-arm study enrolled 28 adults with RP across two vision cohorts. Participants received a single intravitreal injection of allogeneic RPCs at escalating dose levels (0.5, 1.0, 2.0, or 3.0 million cells). The primary objective was safety, with exploratory efficacy endpoints including best-corrected visual acuity (BCVA) and patient-reported outcomes.

Key findings include:

• Intravitreal RPC injection was well tolerated at all dose levels. The majority of adverse events were mild to moderate and transient in nature. Importantly, there were no signs of graft rejection.
• While designed as a safety study, exploratory efficacy data suggested potential vision benefits. At Month 12, mean BCVA changes (treated vs. untreated eyes) were:
  • 0.5M dose: +1.4 letters
  • 1.0M dose: +1.0 letters
  • 2.0M dose: +4.8 letters
  • 3.0M dose: +9.0 letters
• Patients also reported improvements in light sensitivity, object recognition, color discrimination, and reading ability.

“These encouraging results demonstrate that a single intravitreal injection of RPCs was safe and well tolerated, with exploratory signals suggesting a potential dose-related treatment effect,” said Henry Klassen MD, PhD and Co-Founder of jCyte. “While these findings must be interpreted with caution, they provide important rationale for advancing into later-stage controlled studies.”

The RPC technology has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, underscoring its potential to address a serious unmet medical need. Ongoing and planned future trials will further evaluate the therapy’s efficacy and durability in a larger RP population.

The activities described were made possible by grant funding from the California Institute of Regenerative Medicine (CIRM).

About Retinitis Pigmentosa

Retinitis pigmentosa (RP) is a group of rare inherited retinal diseases that cause progressive vision loss due to degeneration of photoreceptor cells. There are currently no broadly available disease-modifying therapies for RP, and patients face inevitable decline in visual function.

About the Gavin Herbert Eye Institute

The Gavin Herbert Eye Institute is dedicated to advancing the understanding and treatment of eye diseases through innovative research and clinical care.

About the California Institute for Regenerative Medicine (CIRM)

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world’s largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality.

About jCyte

jCyte, Inc. is a clinical-stage biotech company focused on developing its first-in-class allogeneic cell therapy, jCell, for retinitis pigmentosa (RP) and other retinal degenerative disorders. The treatment has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation and is administered as a minimally invasive intravitreal injection. Currently there are no FDA approved therapies for over 99% of RP patients. The company is pioneering a new era of regenerative therapies to address the significant unmet medical needs of patients suffering from a broad set of retinal degenerative diseases and is currently recruiting for its JC02-88 trial. For more information, visit www.jcyte.com.

Contacts

jCyte, Inc.

Victor Chao

Vice President Commercial Strategy and Operations

Media@jcyte.com

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