Judo Bio’s Megalin-STRIKERs Achieve First Demonstration of Functional Pharmacodynamic Effects from Kidney Selective Gene Silencing in Non-Human Primates




Judo Bio’s Megalin-STRIKERs Achieve First Demonstration of Functional Pharmacodynamic Effects from Kidney Selective Gene Silencing in Non-Human Primates

Data presented at Kidney Week 2025 showed single subcutaneous administration of megalin-STRIKERs resulted in increased excretion of disease-related solute levels lasting for at least 2 months  

Dr. Ravi Thadhani, internationally recognized nephrology leader, joins Judo Bio Advisory Board

CAMBRIDGE, Mass., Nov. 08, 2025 (GLOBE NEWSWIRE) — Judo Bio, a biotechnology company pioneering oligonucleotide medicines delivery to the kidney, today announced the presentation of data in non-human primates showing the first demonstration of a functional effect of its megalin-STRIKER on disease-related solute excretion in the kidney, consistent with target gene silencing by an siRNA therapeutic. The data were presented at the American Society of Nephrology (ASN) Kidney Week 2025 taking place from November 5-9 in Houston, TX. 

Megalin-STRIKERs are ligand-siRNA conjugates that bind to megalin receptors on proximal tubular epithelial cells (PTECs) in the kidney, resulting in cell-specific uptake of oligonucleotide and subsequent gene silencing of the target mRNA. The data presented at ASN demonstrate selective distribution into the PTECs and an increase in the excretion of disease-related solute from the kidney, based on measurement in urine. These data provide translational evidence for developing these siRNA therapeutics for a range of systemic and renal diseases.

“We are excited to share the progress we’ve made in advancing our STRIKE platform, culminating in an important translational milestone — the demonstration of biological change consistent with target gene silencing by an siRNA therapeutic delivered to the kidney,” said Alfica Sehgal, PhD, Chief Scientific Officer of Judo Bio. “We have taken a deliberate, stepwise approach to building a robust and modular platform that enables broad therapeutic application and advancement of our first megalin-STRIKER into the clinic in the near future.”

The data presented by Judo Bio at ASN showed preclinical translation of megalin-STRIKERs from rodents to non-human primates, and from target gene silencing to functional pharmacodynamic effect. Key findings include:

• Megalin-STRIKERs distributed specifically to PTECs in the kidney across both species.
• In rodents, single administration of megalin-STRIKERs achieved approximately 70% target gene knockdown sustained for up to 2 months.
• In non-human primates, single administration of megalin-STRIKERs significantly increased the amount of excreted disease-related solute that lasted for 2 months post dose, based on measurement in urine.
• No adverse effects were observed in both mice and non-human primates, including no change in in hematology and serum chemistry parameters or elevations in markers of kidney injury.

Judo Bio’s ASN poster presentation is available here on the company’s website.

Dr. Ravi Thadhani joins Judo Bio Advisory Board

Judo Bio also announced that Ravi Thadhani, MD, MPH, an internationally recognized leader in nephrology, has joined the company’s Advisory Board. Dr. Thadhani is Executive Vice President of Clinical Affairs and Chief Medical Officer for Cedars-Sinai Medical Center and Cedars-Sinai Health System, and has recently been elected to the National Academy of Medicine.   

“We are thrilled to welcome Dr. Thadhani, whose extensive experience in nephrology, drug development, and regulatory affairs will help guide our transition toward a clinical-stage company.” said Rajiv Patni, MD, Chief Executive Officer of Judo Bio. “He joins us as we are presenting data to the nephrology community at ASN, showing our important translational progress that supports our plans to advance megalin-STRIKERs to the clinic.”

“Judo’s progress in building a novel approach to discover siRNA therapeutics targeted to the kidney and demonstrating potent and selective gene knockdown in specific kidney regions is impressive. It is exciting to be a part of a promising therapeutic approach that has the potential to impact the health and well-being of patients, and I am delighted to join the Judo team at a time when the company is on the cusp of advancing its initial drug candidates toward the clinic.”

Dr. Thadhani has more than 30 years of experience as a general and specialized internal medicine physician, a clinical and translational investigator, and a leader in life sciences and academia. Prior to his current role at Cedars-Sinai, Dr. Thadhani oversaw Emory University’s renowned academic health sciences enterprise which included 11 hospitals and top-tier schools of medicine, nursing, and public health. He serves as a member of the Cardiovascular and Renal Drugs Advisory Panel for the U.S. Food and Drug Administration (FDA). Previously, he worked at Mass General Brigham as chief academic officer and professor of medicine at Harvard Medical School. Thadhani was Chief of the Division of Nephrology at Mass General Hospital, and for more than 20 years he managed a research laboratory with a focus on kidney disease and on developing diagnostics and therapeutics for patients with preeclampsia. He is the recipient of numerous awards and honors. Dr. Thadhani earned his Doctor of Medicine degree from the University of Pennsylvania School of Medicine, his Master of Public Health degree from the Harvard T.H. Chan School of Public Health, and his bachelor’s degree from the University of Notre Dame.

About Judo Bio
Judo Bio is pioneering oligonucleotide medicines delivered to the kidney, opening the way for new genetic medicines for systemic and renal diseases. With its STRIKE (Selectively Targeting RNA Into KidnEy) platform, the company is using a proprietary approach to create ligand-RNA conjugate drugs designed for receptor-mediated uptake by specific kidney cell types, resulting in gene silencing of disease-modifying target genes. Judo Bio’s initial pipeline programs leverage megalin-STRIKERs to selectively deliver siRNA therapeutics to the proximal tubule of the kidney to silence mRNA expression of target proteins, thereby inhibiting the uptake of circulating solutes linked to systemic diseases. Located in Cambridge, MA, Judo Bio’s team, board and advisors include experts in oligonucleotide therapies and innovative drug development. For more information, visit www.judo.bio and follow us on LinkedIn.

CONTACT: Media Contact:
Kathryn Morris, The Yates Network LLC
914-204-6412
kathryn@theyatesnetwork.com

Jade Biosciences Presents New Data Demonstrating a Favorable Preclinical Safety Profile of JADE101 and a Translational Analysis of APRIL Mediated Biomarker Responses at the American Society of Nephrology Kidney Week 2025




Jade Biosciences Presents New Data Demonstrating a Favorable Preclinical Safety Profile of JADE101 and a Translational Analysis of APRIL Mediated Biomarker Responses at the American Society of Nephrology Kidney Week 2025

SAN FRANCISCO and VANCOUVER, British Columbia, Nov. 08, 2025 (GLOBE NEWSWIRE) — Jade Biosciences, Inc. (“the Company” or “Jade”), (Nasdaq: JBIO), a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today presented two posters for JADE101, its investigational anti-A PRoliferation-Inducing Ligand (APRIL) monoclonal antibody for the treatment of immunoglobulin A nephropathy (IgAN), at the American Society of Nephrology (ASN) Kidney Week 2025.

JADE101 is designed to selectively inhibit APRIL, a key driver of pathogenic IgA production in IgAN, a progressive autoimmune disease that frequently leads to end-stage kidney disease over a patient’s lifetime. Jade has engineered JADE101 with properties intended to capture the full efficacy of APRIL pathway inhibition while enabling patient-friendly subcutaneous dosing, supported by a differentiated pharmacokinetic and pharmacodynamic profile demonstrated in non-human primates (NHPs). JADE101 is currently being evaluated in a Phase 1 healthy volunteer trial, with interim data expected in the first half of 2026 that is anticipated to define the dose and dose interval for future studies in IgAN patients.

“We believe the selective anti-APRIL class will represent the foundational therapeutic approach for treatment of IgAN, and JADE101 has been specifically engineered to deliver the full potential of this mechanism,” said Andrew King, Ph.D., Chief Scientific Officer and Head of R&D at Jade Biosciences. “These new preclinical data in NHPs demonstrate that JADE101 is highly selective, is well tolerated at toxicological doses, and is not broadly immunosuppressive. Additionally, our translational modeling builds further confidence that biomarker responses observed in healthy volunteers are expected to translate into meaningful outcomes for patients with IgAN. Interim biomarker data from our ongoing Phase 1 healthy volunteer study are anticipated to define the dose and dosing interval selection for JADE101, with the goal of supporting rapid advancement into IgAN patient trials with a potentially best-in-class therapy.”

Nonclinical Safety Profile of JADE101 (Poster #SA-PO0255)

New preclinical safety data highlight JADE101’s favorable safety profile and support its potential as a selective, disease-modifying treatment with low risk of toxicity:

• JADE101 was well tolerated in NHPs at all doses tested preclinically, including the highest dose evaluated in GLP toxicology studies, which was established as the no observed adverse effect level (NOAEL). These results provide wide safety margins that support the first-in-human doses being evaluated in the ongoing Phase 1 healthy volunteer trial.
• Across studies, JADE101 showed no off-target binding in a panel of more than 6,000 human proteins, no human tissue cross-reactivity, and no cytokine release in human whole blood assays.
• In NHPs, JADE101 treatment resulted in reversible reductions in serum immunoglobulins consistent with its mechanism of action, including IgA and IgM reductions of approximately 55–68% and 62–75%, respectively, and a more modest IgG reduction of 35–48%, all of which returned toward baseline following JADE101 clearance.
• Despite reductions in circulating immunoglobulins, JADE101-treated NHPs generated antibody responses to a test immunization (KLH) that were comparable to untreated controls, consistent with the preserved vaccination response observed in healthy volunteers following administration of a previous anti-APRIL monoclonal antibody.
• JADE101 administration in NHPs did not impact serum concentrations of BAFF or inflammatory cytokines, resulted in no histological changes in tissues, and had no effect on circulating immune cell populations, including B, T, or NK cells – supporting its potential as a well-tolerated treatment, devoid of broad immune suppression.

Translational Modeling of Biomarker Responses to APRIL Inhibition (Poster #SA-PO0272)

A second presentation described a translational assessment of the consistency of biomarker responses to APRIL inhibition across NHPs, healthy volunteers and IgAN patients, and the associations between these biomarkers and clinical responses in IgAN. Biomarker responses to JADE101 in the ongoing healthy volunteer study are anticipated to define dose and dose interval selection for future clinical trials in IgAN patients:

• Analyses demonstrated that in vitro APRIL binding affinity is predictive of in vivo IgA-lowering potency across NHP and human data sets, supporting that high APRIL binding affinity results in potent IgA reduction in vivo in NHPs and humans.
• Clinical observations from healthy volunteers further demonstrate that high APRIL binding affinity is a key determinant of the magnitude and duration of free APRIL and IgA reduction at a given anti-APRIL dose level.
• Pharmacokinetic and free APRIL suppression profiles of anti-APRIL monoclonal antibodies were consistent between healthy volunteers and patients with IgAN, supporting the use of healthy volunteer PK and biomarker results for dose selection in IgAN patients.
• Trial level analyses indicate the kinetics and magnitude of IgA reduction is highly consistent between healthy volunteers and IgAN patients (r = 0.93), and that the reduction of Gd-IgA1 measured in IgAN patients is highly consistent with the reductions in total IgA (r = 0.96). Furthermore, the early IgA reduction observed in IgAN patients is predictive of subsequent proteinuria reduction (r = 0.89).
• The largest reductions in proteinuria and the highest rates of clinical remission (proteinuria < 0.3 g/day) in IgAN patients were observed with the highest levels of APRIL suppression.

These analyses suggest that pharmacokinetic and biomarker responses observed in healthy volunteers are informative of anticipated therapeutic responses in IgAN patients. The analysis also highlights that the depth and duration of APRIL suppression can be linked to anticipated reductions in total IgA, Gd-IgA1, and proteinuria that are ultimately associated with preserving kidney function and delivering disease-modifying clinical outcomes for patients with IgAN. Based on JADE101’s differentiated NHP pharmacokinetic profile, the Company anticipates the potential for convenient, infrequent, subcutaneous dosing.

About JADE101 

JADE101 is a novel, fully human monoclonal antibody that selectively blocks APRIL with ultra-high binding affinity and is engineered for half-life extension. Preclinical studies demonstrated potent, sustained IgA suppression after a single dose in non-human primates, with a serum half-life of approximately 27 days. JADE101 was designed to avoid formation of high molecular weight immune complexes, with the goal of supporting predictable pharmacokinetics and reduced immunogenicity risk. Its differentiated pharmacokinetic and pharmacodynamic profile supports the potential for infrequent and convenient subcutaneous dosing, an important consideration for a condition often diagnosed in young adulthood and potentially requiring life-long treatment. 

A Phase 1 randomized, double-blind, placebo-controlled clinical trial evaluating single ascending subcutaneous doses of JADE101 in healthy adult volunteers is ongoing. The Company expects data from the Phase 1 trial to define dose and dosing interval selection for later-stage studies, based on biomarker responses associated with optimal clinical activity in IgAN patients. More information on the JADE101 Phase 1 trial is available on ClinicalTrials.gov.

About Jade Biosciences, Inc.  
  
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE-003, an undisclosed antibody discovery program, both currently in preclinical development.  Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.  
  
​​Forward-Looking Statements  
  
Certain statements in this communication, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the “safe harbor” provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Jade’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, the expected timeline for interim data from the Phase 1 clinical trial of JADE101, plans for future clinical trials, the potential for the anti-APRIL class to become the foundational therapeutic approach for treatment of patients with IgAN, the potential of JADE101 and Jade’s other product candidates to become best-in-class therapies and their potential therapeutic uses, efficacy, safety profiles and dosing. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,” “strategy,” “target,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “possible,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Jade will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Jade’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the Phase 1 clinical trial of JADE101 and any future clinical trials may be delayed or may not demonstrate desirable efficacy; adverse events or safety signals may occur; Jade may experience unanticipated difficulties or delays in the product development process; Jade’s product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; enrollment or regulatory challenges; risks associated with Jade’s dependence on third-parties for the development, manufacture and supply of its product candidates; and the other risks, uncertainties and factors more fully described in Jade’s most recent filings with the Securities and Exchange Commission (including the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025). Should one or more of these risks or uncertainties materialize, or should any of Jade’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You should not place undue reliance on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Jade does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Jade.   

Jade Biosciences Contact  

Priyanka Shah  
Media@JadeBiosciences.com  
IR@JadeBiosciences.com  
908-447-6134  
  

MemoMaster Unveiled: How This Memo Master Cutting-Edge Brain Support Supplement Is Redefining Focus and Memory Health for the Digital Era




MemoMaster Unveiled: How This Memo Master Cutting-Edge Brain Support Supplement Is Redefining Focus and Memory Health for the Digital Era

Boost memory, focus & mental clarity with MemoMaster – a clinically inspired brain supplement for sharper thinking, sustained energy & long-term brain health.

New York, Nov. 08, 2025 (GLOBE NEWSWIRE) — Introduction

New York City, Nov. 08, 2025, In a significant development for the global cognitive health industry, MemoMaster, a newly formulated nootropic supplement, has been officially introduced to the U.S. market this quarter, aiming to reshape the standards of memory enhancement and brain performance. Backed by neuro-nutrition research and precision formulation, MemoMaster emerges as one of 2025’s most promising entrants in the natural brain support category, offering users a clinically inspired solution to maintain focus, recall, and long-term cognitive vitality.

What sets MemoMaster apart is its fusion of ancient botanical extracts and modern neuro-nutritional science. The formulation incorporates well-researched compounds such as Bacopa Monnieri, Ginkgo Biloba, Lion’s Mane Mushroom, and Phosphatidylserine—ingredients clinically associated with cognitive endurance, memory consolidation, and neural protection. Unlike synthetic stimulants that offer only short bursts of alertness, MemoMaster supports sustained clarity and mental energy through adaptive stress modulation and antioxidant support.

MemoMaster’s launch aligns with broader industry trends identified in 2025 reports by global wellness analysts, highlighting rapid growth in cognitive enhancement products among professionals, students, and aging adults. The formula’s stimulant-free approach, backed by quality manufacturing standards and scientific rationale, positions it as a safe, long-term cognitive companion for individuals seeking natural, data-driven brain performance support.

With this timely launch, MemoMaster is not only introducing a new product—it’s setting a benchmark for how natural supplements can integrate modern neuroscience with practical daily wellness, addressing the core challenges of focus, memory, and cognitive longevity in 2025’s fast-paced digital world.

Visit the Official Memo Master Website

What Is MemoMaster?

MemoMaster is a premium brain support supplement designed to enhance cognitive performance, memory recall, and mental clarity. Developed with a focus on scientific research and natural ingredients, MemoMaster provides a holistic solution for individuals facing cognitive fatigue, mental stress, or challenges in maintaining sustained focus throughout the day. Its formulation is crafted to support both short-term mental alertness and long-term brain health.

At the core of MemoMaster’s effectiveness is its carefully selected blend of natural compounds. Lion’s Mane Mushroom, known for stimulating nerve growth factor (NGF), supports neuron repair and promotes cognitive resilience. Bacopa Monnieri aids memory formation and retention, while Ginkgo Biloba improves cerebral blood flow, delivering oxygen and nutrients efficiently to the brain. Omega-3 DHA supports the structural integrity of brain cells, protecting them against oxidative stress and age-related decline. Rhodiola Rosea works as an adaptogen, reducing mental fatigue and maintaining energy balance under stressful conditions. Each of these ingredients has been chosen for its proven ability to enhance specific aspects of cognitive function.

MemoMaster operates through a synergistic approach, where each ingredient complements the other to optimize memory, focus, and overall brain performance. By enhancing neurotransmitter activity, promoting neuroplasticity, and protecting neurons from oxidative damage, Memo Master supports sharper thinking, quicker recall, and sustained attention. This multifaceted action ensures that users experience tangible cognitive benefits while supporting long-term mental wellness.

MemoMaster represents a proactive approach to brain health. It addresses the increasing demands of modern life by providing natural, science-backed support for cognitive performance. Whether for professionals, students, or adults looking to maintain peak mental function, MemoMaster offers a reliable, research-informed solution for enhancing focus, memory, and overall mental clarity, making it an essential addition to daily cognitive wellness routines.

Experience sustained mental energy and clarity – Visit the Official MemoMaster Website

How MemoMaster Works?

MemoMaster is designed to optimize brain performance through a scientifically formulated blend of natural ingredients that target key cognitive pathways. Unlike temporary stimulants that provide short-lived energy spikes, Memo Master addresses the underlying mechanisms of memory, focus, and mental clarity, ensuring sustainable cognitive support throughout the day. Its approach focuses on three primary areas: neuron health, neurotransmitter activity, and cerebral circulation.

The supplement includes Lion’s Mane Mushroom, a clinically studied ingredient that stimulates Nerve Growth Factor (NGF). NGF is essential for the repair, growth, and maintenance of neurons, which supports long-term cognitive health and improves memory formation. Bacopa Monnieri complements this effect by enhancing neurotransmitter function, facilitating faster information processing and more efficient memory recall. These ingredients work in tandem to improve mental sharpness, allowing users to retain and retrieve information more effectively.

Ginkgo Biloba, another core component, enhances cerebral blood flow, increasing the delivery of oxygen and nutrients to brain cells. Improved circulation supports alertness, concentration, and mental energy, particularly during periods of prolonged cognitive activity. Additionally, Omega-3 DHA nourishes neurons and protects them from oxidative stress, supporting structural integrity and cognitive resilience over time.

MemoMaster also incorporates adaptogenic support through Rhodiola Rosea, which helps regulate stress hormones and reduce mental fatigue. By maintaining a balanced stress response, Memo Master ensures sustained focus and energy, even under high-pressure conditions. Phosphatidylserine is included to enhance cell-to-cell communication within the brain, improving synaptic efficiency and overall cognitive performance.

The synergistic combination of these ingredients means that MemoMaster not only addresses immediate mental performance but also promotes long-term brain health. It enhances memory, supports concentration, reduces fatigue, and protects neurons from age-related decline. Each capsule delivers precise, research-backed doses to maximize effectiveness and ensure consistent cognitive support.

Manufactured in a GMP-certified facility in the United States, MemoMaster maintains strict quality control standards. Its clean-label formulation avoids artificial additives, stimulants, and fillers, making it a reliable daily supplement. Through its multifaceted action on neuron repair, neurotransmitter optimization, and cerebral circulation, Memo Master provides comprehensive brain support designed to keep the mind sharp, focused, and resilient.

Take control of your cognitive health – Visit the Official MemoMaster Website

Memo Master Supplement Key Ingredients

MemoMaster’s effectiveness is rooted in its carefully selected natural ingredients, each chosen for their clinically supported roles in promoting cognitive health. The formulation combines nootropics, adaptogens, and brain-boosting nutrients to enhance memory, focus, and mental clarity while supporting long-term brain function. Every ingredient is included at a research-backed dose to ensure optimal performance and reliability.

Bacopa Monnieri is a cornerstone of MemoMaster, known for its ability to enhance memory formation and recall. It supports neurotransmitter activity, particularly acetylcholine, which is essential for efficient information processing. Additionally, Bacopa Monnieri has antioxidant properties that help protect neurons from oxidative stress, contributing to long-term cognitive resilience.

Lion’s Mane Mushroom stimulates the production of Nerve Growth Factor (NGF), which plays a critical role in neuron repair and growth. By promoting neuroplasticity, Lion’s Mane supports the brain’s ability to adapt, form new connections, and retain information. This ingredient is key to supporting memory retention and cognitive sharpness over time.

Ginkgo Biloba enhances cerebral blood flow, ensuring that brain cells receive adequate oxygen and nutrients. This improved circulation boosts alertness, concentration, and mental energy, making it easier to maintain focus during demanding cognitive tasks. Ginkgo also provides neuroprotective effects, helping to safeguard neurons against environmental stressors and age-related decline.

Phosphatidylserine is essential for maintaining healthy cell membranes and optimizing communication between brain cells. Its inclusion in Memo Master supports faster information processing, sharper focus, and improved memory recall.

Rhodiola Rosea, an adaptogen, helps balance stress hormones and reduces mental fatigue, promoting sustained energy and concentration. It enhances the brain’s resilience to daily stressors, ensuring stable cognitive performance throughout the day.

Omega-3 DHA, a vital fatty acid, supports the structural integrity of brain cells, protects neurons from oxidative damage, and contributes to mood stability. Its neuroprotective benefits complement the overall formula, ensuring both immediate cognitive enhancement and long-term brain health.

Together, these ingredients create a synergistic formula designed to deliver measurable cognitive benefits. MemoMaster’s clean-label, stimulant-free formulation ensures safe and reliable use, making it an effective daily solution for memory support, focus, mental clarity, and long-term brain wellness.

MemoMaster Formula Benefits

MemoMaster is designed to deliver a comprehensive suite of cognitive benefits, targeting memory, focus, mental clarity, and overall brain health. Its scientifically formulated blend of natural ingredients works synergistically to address multiple aspects of cognitive performance, offering measurable enhancements for daily mental function.

The primary benefit of Memo Master is enhanced memory recall. Ingredients like Bacopa Monnieri and Phosphatidylserine support the formation and retrieval of memories by optimizing neurotransmitter activity. This ensures that information is processed efficiently and can be recalled quickly when needed, improving overall mental performance. Lion’s Mane Mushroom contributes to neuron growth and neuroplasticity, further enhancing the brain’s capacity to retain and recall information over time.

Memo Master also delivers improved focus and attention. Ginkgo Biloba increases blood flow to the brain, providing essential oxygen and nutrients to support alertness and sustained concentration. Rhodiola Rosea balances stress hormones and combats mental fatigue, helping users maintain consistent attention during demanding cognitive tasks. These combined effects result in sharper focus and heightened mental clarity throughout the day.

Another significant benefit is neuroprotection and long-term brain support. Omega-3 DHA and antioxidant-rich compounds protect neurons from oxidative stress and age-related decline, maintaining brain structure and function. This not only supports immediate cognitive performance but also contributes to long-term mental resilience and overall brain health.

MemoMaster also helps balance mood and mental energy. By supporting neurotransmitter function and reducing the impact of stress, the supplement helps maintain mental stability, ensuring users can think clearly, make decisions effectively, and perform at their best.

Finally, MemoMaster’s clean-label, stimulant-free formula ensures safe daily use without jitters or energy crashes. With consistent use, the supplement can help optimize memory, improve focus, reduce fatigue, and enhance mental clarity, providing a complete solution for modern cognitive demands.

Unlock sharper memory and laser-like focus with MemoMaster – the brain support supplement designed for modern life.

How to Use Memo Master

For optimal results, MemoMaster is recommended for daily use, following a simple, consistent routine. Ideally taken with a meal, provides the body and brain with precise doses of key ingredients to support memory, focus, and overall cognitive function. Daily supplementation ensures that the active compounds work cumulatively, enhancing both short-term mental performance and long-term brain health.

MemoMaster integrates seamlessly into a balanced lifestyle. Adequate hydration, proper nutrition, regular physical activity, and sufficient sleep complement the supplement’s effects, creating an environment for maximal cognitive efficiency. The formula is free from stimulants, fillers, or artificial additives, making it safe for long-term use without causing energy spikes or crashes.

Consistency is essential. Regular intake over weeks ensures that the brain receives ongoing support, allowing ingredients like Bacopa Monnieri, Lion’s Mane Mushroom, and Omega-3 DHA to strengthen neural pathways, support neuron growth, and enhance memory retention. Combining MemoMaster with stress management practices, such as mindfulness or light exercise, can further amplify its benefits.

While MemoMaster is designed for general adult use, consulting a healthcare professional is recommended for individuals with pre-existing medical conditions or those taking prescription medications. By following the recommended dosage and maintaining a healthy routine, MemoMaster can serve as a reliable and effective daily cognitive support solution, promoting sharper focus, improved memory recall, and sustained mental clarity.

Who Needs the MemoMaster Supplement?

MemoMaster is ideal for anyone looking to maintain and enhance their cognitive performance. Its formulation supports memory, focus, and mental clarity, making it suitable for a wide range of individuals facing different mental challenges.

Professionals in demanding work environments benefit from MemoMaster’s focus-enhancing properties, maintaining productivity and mental sharpness throughout long workdays. Its neuroprotective ingredients help reduce mental fatigue and sustain alertness during high-pressure tasks.

Students can use MemoMaster to improve memory retention, accelerate learning, and maintain concentration during study sessions or examinations. Bacopa Monnieri and Phosphatidylserine support efficient information processing, while Ginkgo Biloba enhances focus and attention span.

Adults experiencing age-related cognitive changes gain support for memory and long-term brain health. Omega-3 DHA and Lion’s Mane Mushroom contribute to neuron protection, repair, and growth, reducing the risk of cognitive decline.

MemoMaster is also suitable for any adult seeking enhanced mental clarity and sustained energy. Rhodiola Rosea balances stress hormones and reduces fatigue, making it easier to remain mentally agile in daily life.

By addressing memory, focus, and neuroprotection simultaneously, MemoMaster serves as a proactive solution for maintaining mental performance, supporting cognitive health, and promoting overall brain wellness, making it relevant for a broad audience in today’s cognitively demanding environment.

Pricing, Packages & Official Website – Where to Buy Memo Master Safely Online

MemoMaster is available exclusively through its official website to ensure authenticity, quality, and access to promotional offers. The supplement is offered in multiple packages to meet different user needs:

• Single Bottle: Ideal for first-time users looking to experience MemoMaster’s benefits without commitment.
• Multi-Bottle Packages: Offer significant cost savings and ensure uninterrupted daily supplementation for optimal results.

Purchasing directly from the official website guarantees product authenticity and access to a 90-day money-back guarantee, allowing users to try MemoMaster risk-free. All orders are fulfilled through secure payment processing, ensuring privacy and convenience.

The official website also provides guidance on recommended usage, detailed ingredient information, and additional resources for supporting cognitive health. By buying from authorized channels, users avoid counterfeit products and receive a formula that meets strict quality standards.

MemoMaster’s pricing structure and availability are designed to support long-term cognitive wellness, offering flexibility and value for those seeking sustained brain health support.

The Science or Technical Framework Behind Brain Health Supplements

MemoMaster formulation is based on extensive research into the biological mechanisms of cognition, memory, and neuronal health. Brain health depends on effective neurotransmission, optimal blood flow, neuron protection, and neuroplasticity.

• Neuroplasticity and Nerve Growth: Ingredients like Lion’s Mane Mushroom stimulate Nerve Growth Factor (NGF), enhancing neuron repair and synaptic connectivity.
• Neurotransmitter Optimization: Bacopa Monnieri and Phosphatidylserine support acetylcholine activity, essential for memory formation, learning, and recall.
• Cerebral Circulation: Ginkgo Biloba improves blood flow to the brain, ensuring that neurons receive oxygen and nutrients necessary for energy and focus.
• Oxidative Protection: Omega-3 DHA and antioxidant compounds protect neurons from oxidative stress, reducing age-related cognitive decline.
• Stress Regulation: Rhodiola Rosea modulates stress hormones, preventing fatigue and supporting sustained mental energy.

By addressing these critical pathways simultaneously, MemoMaster provides a comprehensive, science-backed framework for cognitive enhancement and long-term brain wellness.

Visit The Official MemoMaster Website To Read Customer Reviews About MemoMaster!

Why MemoMaster Is an Emerging Trend in 2025

MemoMaster is gaining attention in 2025 due to increasing awareness of cognitive health, mental wellness, and the effects of digital fatigue on brain performance. Its combination of natural, research-backed ingredients positions it as a reliable supplement for modern cognitive demands.

The trend toward preventive mental wellness highlights the importance of neuroprotection, memory support, and focus enhancement. MemoMaster aligns with this by offering a clean-label, stimulant-free formula, appealing to health-conscious individuals seeking effective, long-term brain support.

Its scientifically inspired approach, quality manufacturing standards, and comprehensive benefits make MemoMaster a standout solution, reflecting broader shifts toward natural, clinically validated cognitive supplements in 2025.

Final Verdict: MemoMaster

Memo Master is a clinically formulated brain support supplement that delivers measurable cognitive benefits, including improved memory recall, enhanced focus, sustained mental clarity, and long-term brain health protection. Its blend of natural nootropics, adaptogens, and nutrients targets multiple cognitive pathways, providing a reliable, safe, and effective solution for adults facing cognitive fatigue, stress, or age-related memory challenges.

Manufactured in a GMP-certified facility and free from artificial stimulants, MemoMaster ensures quality, safety, and consistent performance. With regular use, it supports both immediate mental performance and long-term neuroprotection, making it a proactive solution for maintaining peak cognitive function. For anyone seeking natural, science-backed support for memory, focus, and overall brain wellness, MemoMaster offers a comprehensive, high-quality option designed for daily use.

For more information on MemoMaster, educational content, and direct purchasing, visit the official MemoMaster website.

Company: MemoMaster
555 Republic Dr, Plano, Texas, 75074
Email: support@cartpanda.com
Phone Support: +1-866-637-2482
Website: https://memomaster.cloud/

Disclaimers

The information in this article is provided for general educational purposes only. MemoMaster is marketed as a dietary supplement, not as a prescription medication or medical treatment. It is not intended to diagnose, treat, cure, or prevent any disease. Individual results vary, and readers should consult with a licensed healthcare professional before starting Memo Master or any other supplement, especially if pregnant, nursing, under 18, have a medical condition, or are taking prescription medications.

Consumers are encouraged to use these official channels for customer service requests, refund inquiries, or product-related questions. For the most accurate details on current offers and guarantees, always refer to the official MemoMaster website.

This content is not financial, medical, or legal advice. Readers are responsible for making their own decisions based on official product information and consultation with qualified professionals.

Prices, packages, guarantees, and availability for Memo Master are subject to change at any time. For the most accurate, up-to-date details, consumers should visit the official MemoMaster website directly.

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Novo Nordisk will not increase its proposal to acquire Metsera, Inc. 




Novo Nordisk will not increase its proposal to acquire Metsera, Inc. 

Bagsværd, Denmark, 8 November 2025 – Novo Nordisk today confirms that it does not intend to make an increased offer to acquire Metsera. 

On 30 October 2025, Novo Nordisk announced the submission of an unsolicited proposal to acquire Metsera, Inc. (Metsera) which was declared superior by Metsera’s board of directors.  

On 4 November 2025, Novo Nordisk confirmed that it had submitted an updated unsolicited proposal to acquire Metsera price of 62.20 USD per share in cash (equal to an approximate aggregated equity value of 7.2 billion USD or approximate enterprise value of 6.7 billion USD) and contingent value rights (CVRs) for up to 24.00 USD per share in cash (or an approximate aggregated value of up to 2.8 billion USD) based on the achievement of certain clinical and regulatory milestones which was declared superior by Metsera’s board of directors.  

On 6 November 2025, Novo Nordisk submitted a revised unsolicited proposal at a price of 65.60 USD per share in cash (equal to an approximate aggregated equity value of 7.6 billion USD or approximate enterprise value of 7.1 billion USD) and contingent value rights (CVRs) for up to 20.65 USD per share in cash (or an approximate aggregated value of up to 2.4 billion USD) based on the achievement of certain clinical and regulatory milestones.

We believe that the structure of our potential merger agreement is compliant with antitrust laws. Following a competitive process and after careful consideration, Novo Nordisk will not increase its offer to acquire Metsera consistent with its commitment to financial discipline and shareholder value.  

Novo Nordisk is advancing a pipeline of diverse treatment options for obesity and continues to invest in its promising portfolio of next-generation assets, with the ambition of meeting the needs of millions of people living with diabetes, obesity and their associated comorbidities. It will continue to assess opportunities for business development and acquisitions that meet its criteria for returns and capital allocation and that further its strategic objectives.  

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 78,500 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.

Contacts for further information

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Fangzhou Awarded “Golden Bull Award” for Leadership in AI-Powered Chronic Disease Management




Fangzhou Awarded “Golden Bull Award” for Leadership in AI-Powered Chronic Disease Management

XIAMEN, China, Nov. 08, 2025 (GLOBE NEWSWIRE) — Fangzhou Inc. (“Fangzhou” or the “Company”) (HKEX: 06086), a leading provider of AI-driven Internet healthcare solutions, was recognized with the “Social Responsibility Golden Bull Award” at the 2025 Xiamen Industry Development Conference and Listed Companies (Hong Kong) Golden Bull Awards Ceremony, organized by China Securities Journal.

The conference brought together corporate leaders and investors to discuss how Hong Kong-listed enterprises can leverage innovation and governance to achieve sustainable global growth. This year marked the inaugural edition of the Golden Bull Awards for Hong Kong-listed companies.

Fangzhou was recognized with the “Social Responsibility Golden Bull Award”

Fangzhou distinguished itself among the field of Hong Kong-listed companies to receive the honor, demonstrating not only strong revenue growth and solid profitability, but also leadership in technological innovation and sustained social value creation. The award underscores growing confidence in the company’s “AI + chronic disease management” strategy — a high-growth and high-impact field that is reshaping China’s digital healthcare landscape.

Dr. Xie Fangmin, Founder, Chairman and CEO of Fangzhou, remarked: “We are honored to receive the award and will continue to advance AI-driven chronic disease management and deliver lasting benefits for public health.”

The award comes as China’s National Health Commission recently released policy guidance promoting the application of “AI + Healthcare” as a key national development priority. In line with this direction, Fangzhou has built an AI + H2H (Hospital-to-Home) ecosystem that integrates its proprietary XJ LLM and XS LLM to enhance precision, efficiency, and accessibility in chronic disease management.

In April of this year, Fangzhou and the Guangdong Provincial Institute of Liver Disease jointly established the “AI + Hepatitis Prevention and Control Training Center” to enhance liver disease management through AI technology. In June, the Company joined a rural revitalization initiative led by the Guangdong Communications Administration, advancing digital healthcare infrastructure in rural areas. And more recently in October, Fangzhou launched the “AI + Psoriasis Management New Horizons” public education week, leveraging AI to expand the reach and enhance the quality of health awareness campaigns.

Fangzhou has also let efforts in responsible AI governance, becoming the first Internet healthcare enterprise to join the “Human-Centered AI Development and Governance Initiative” this past July, contributing to high-level policy dialogue on AI–Internet integration. In October, the Company’s XJ LLM received official national registration, highlighting Fangzhou’s commitment to regulatory compliance, and establishing best practices across the medical AI field.

The Company continues to strengthen its leadership position in “AI + weight management”, working with the China Food and Drug Institutions Quality and Safety Promotion Association to develop national standards for AI-enabled weight management. Fangzhou also deepened its strategic collaboration with global pharmaceutical leader Novo Nordisk to jointly develop a digital intelligence ecosystem, combining medical expertise with AI-driven insights to advance the quality and accessibility of chronic disease management across China.

Looking ahead, Fangzhou will continue to build on its leadership as a leading Internet healthcare enterprise, advancing AI-powered chronic disease management while driving forward the industry’s development.

About China Securities Journal Golden Bull Awards
Established by China Securities Journal and approved by national authorities, the Golden Bull Awards are recognized for their rigorous, transparent evaluation system and have become one of China’s most authoritative platforms for fostering positive interaction between industry and capital markets.

About Fangzhou Inc.
Fangzhou Inc. (HKEX: 06086) is China’s leading online chronic disease management platform, serving 52.8 million registered users and 229,000 physicians (as of June 30, 2025). The Company specializes in delivering tailored medical care and AI-enabled precision medicine solutions. For more information, visit https://investors.jianke.com.

Media Contact
For further inquiries or interviews, please reach out to:
Xingwei Zhao Associate Director of Public Relations Email: pr@jianke.com

Disclaimer: This press release contains forward-looking statements. Actual results may differ materially from those anticipated due to various factors. Readers are cautioned not to place undue reliance on these statements

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0e287d87-2e8c-48dd-89d8-66a52c319d55

Smile Spa Camarillo Officially Opens its Doors, Offering State-of-the-Art Dental Care in Ventura County




Smile Spa Camarillo Officially Opens its Doors, Offering State-of-the-Art Dental Care in Ventura County

Camarillo, CA, Nov. 07, 2025 (GLOBE NEWSWIRE) — Smile Spa Camarillo, a modern dental office led by Dr. Joelle Abed Elahad and Dr. Shawn Nguyen, is proud to announce that it has officially opened its doors at 400 W Ventura Blvd, Suite 240, in Camarillo, California. Conveniently located in the heart of Ventura County with easy access from Highway 101, the practice is now fully operational and welcoming patients from Camarillo and neighboring communities looking for patient-centered and tech-driven dental care.

Dr. Joelle Abed Elahad and Dr. Shawn Nguyen

Smile Spa Camarillo was established to provide patients with a modern integrated approach to dental care in a setting that supports both clinical efficiency and patient comfort. Dr. Joelle and Dr. Nguyen aim to meet a wide range of dental health needs while emphasizing clear communication, evidence-based treatment protocols, and a streamlined care experience, making even complex dental procedures approachable.

“We established Smile Spa Camarillo to provide patients with consistent, comprehensive care supported by modern dental technology,” said Dr. Joelle. “Our approach emphasizes clear communication, accurate diagnostics, and efficient treatment planning, so patients can feel confident that their care is both clinically sound and tailored to their individual needs.”

Dr. Joelle and Dr. Nguyen oversee Smile Spa Camarillo with a shared focus on clinical precision, modern technology, and individualized care. Together, they bring years of combined experience and advanced training across multiple areas of dentistry. Their approach emphasizes ongoing education, evidence-based practices, and a commitment to delivering consistent, patient-centered outcomes.

Comprehensive Services and Continuity of Care

Smile Spa Camarillo is equipped to provide a full spectrum of services ranging from general, cosmetic, surgical, and emergency dental services. This all-in-one approach reduces the need for external referrals and allows for consistent, streamlined care throughout the patient journey.

“By offering comprehensive services internally, we reduce delays and simplify the communication between doctor and patient,” explained Dr. Nguyen. “It’s a more efficient, effective model that supports long-term outcomes and stronger patient relationships.”

With advanced tools like CBCT scanners and laser technology, the clinic supports more accurate diagnostics and minimally invasive treatment protocols. In addition to routine check-ups and cleanings, patients have access to restorative treatments like crowns and implants as well as specialized offerings such as TMD therapy, Botox for clenching and grinding, and even IV drip therapy.

Key features and offerings:

• Modern Dental Technology: Features CBT imaging, digital X-rays, intraoral scanners, and soft-laser equipment to support accurate diagnostics and efficient treatment.
• Comprehensive Service Offering: Includes preventive, restorative, cosmetic, surgical, implant, and emergency dental care.
• Specialized Procedures: Offers services such as TMD management, Botox for bruxism, sedation options, laser-assisted treatments, and IV hydration support.
• Multilingual Staff: Team members are proficient in English, Spanish, Arabic, Vietnamese, and Russian to accommodate a diverse patient population.
• Emergency Availability: Provides weekend support for urgent dental needs outside of regular office hours.
• Patient-Centered Care: Clinic prioritizes patient comfort while maintaining a high standard of clinical care.

Accessible Dentistry Through Flexible Payment Options

In line with its commitment to inclusivity, Smile Spa Camarillo has adopted a patient-friendly approach to financial accessibility. It accepts most major dental insurance plans and offers flexible financing options for uninsured or underinsured patients. This allows for individuals and families to prioritize their oral health without undue financial stress.

“Our goal is to remove barriers to care, whether through language support, flexible scheduling, or financing. We want every patient to feel confident that high-quality dental care is within reach,” added Dr. Joelle.

To learn more about available services, treatment options, or to schedule an appointment, please visit https://camarillocosmeticdentistry.com/ or call 805-243-9588. The clinic is currently accepting new patients, and it is open from Monday to Friday for routine appointments and on weekends for emergencies.

About Smile Spa Camarillo

The Smile Spa Camarillo is a modern dental practice located at 400 W Ventura Blvd, Suite 240, in Camarillo, California. Under the leadership of Dr. Joelle Abed Elahad and Dr. Shawn Nguyen, the clinic offers a full range of general, cosmetic, restorative, surgical, and emergency dental services. The practice integrates advanced technology such as CBCT imaging, digital X-rays, and intraoral scanning to support accurate diagnostics and efficient treatment. With a multilingual team and a patient-centered approach, The Smile Spa Camarillo serves individuals and families throughout Ventura County in a professional, inclusive, and comfort-focused environment.

Media Contact
Company Name: Smile Spa Camarillo
Contact Person: Amin Nassiri
Contact Number: (310) 592-6293
Email: amin@dentistnerds.com
Country: United States
Website: https://camarillocosmeticdentistry.com/
Socials: https://www.instagram.com/thedentalcouple/

CONTACT: Media Contact
Company Name: Smile Spa Camarillo
Contact Person: Amin Nassiri
Contact Number: (310) 592-6293
Email: amin@dentistnerds.com
Country: United States
Website: https://camarillocosmeticdentistry.com/
Socials: https://www.instagram.com/thedentalcouple/

Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy




Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy

• Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgAN
• ORIGIN Phase 3 trial met its primary endpoint at the prespecified interim analysis of proteinuria reduction with 46% reduction from baseline and 42% reduction vs placebo at week 36 (p<0.0001)
• If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN; potential FDA approval in 2026

BRISBANE, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN).

The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial, which met the primary endpoint of reduction in proteinuria at week 36. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. The safety profile of atacicept across the ORIGIN program appears favorable, and comparable to placebo. Results of the interim analysis were presented as a late-breaking oral presentation at the opening plenary session of the American Society of Nephrology Kidney Week meeting and published in a manuscript in the New England Journal of Medicine on November 6.

“The submission of our first BLA marks an inflection point in our journey as a company, bringing us closer to delivering a breakthrough treatment that could change the standard of care for patients with IgAN and other autoimmune kidney diseases,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Atacicept has the potential to address the unmet medical need in IgAN as the first dual BAFF/APRIL inhibitor. We look forward to working with the U.S. regulatory authorities to bring this treatment to patients. We are energized about the path forward and thankful to the patients, caregivers, HCPs, and the Vera Therapeutics team, whose contributions made this submission possible.”

IgAN is a serious and progressive autoimmune disease of the kidney, for which there remains a high unmet need for new disease-modifying treatments that target the upstream source of the disease. In at least 50% of patients, IgAN can lead to end-stage kidney disease or kidney failure, which has considerable morbidity and impact on patients’ lives. Atacicept is being developed as an at-home self-administered subcutaneous once-weekly injection that inhibits B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), cytokines that drive B-cell production of autoantibodies associated with IgAN and potentially other autoimmune kidney diseases.

ORIGIN 3 (NCT04716231) is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint of the prespecified 36-week interim analysis was the change in 24-hour UPCR compared to placebo. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR and is expected to complete in 2027. For more information about ORIGIN 3, please visit http://www.clinicaltrials.gov.

About Atacicept
Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases. 

About the Atacicept Clinical Program
The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. 

The ORIGIN Phase 3 trial met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36. Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo. 

Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera Therapeutics believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. 

The ORIGIN Extend study provides ORIGIN study participants with extended access to atacicept until its potential commercial availability in their region and captures longer-term safety and efficacy data. Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial.

About Vera Therapeutics
Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell–mediated diseases. Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please visit www.veratx.com.

Forward-looking Statements
Statements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the potential approval of atacicept by the FDA and related timing of such approval; Vera Therapeutics’ ability to change the standard of care for patients with IgAN and other autoimmune kidney diseases; atacicept’s potential to address the unmet medical need in IgAN; the expected completion date of ORIGIN 3; the potential for atacicept to be best-in-class; and the plans, commitments, aspirations and goals under the caption “About Vera Therapeutics”. Words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera Therapeutics’ business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera Therapeutics’ filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

For more information, please contact:

Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com

Media Contact:
Debra Charlesworth
Vera Therapeutics
415-854-8051
corporatecommunications@veratx.com

Data for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025




Data for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025

– Late-breaking presentation of Explore-CKD trial at ASN Kidney Week –

– Pivotal Phase 3 Launch-HTN trial featured in the “Best of JAMA and NEJM” session –

RADNOR, Pa., Nov. 07, 2025 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company developing therapies to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that clinical data for lorundrostat were presented at the American Society of Nephrology (ASN) Kidney Week 2025. Findings included a late-breaking oral presentation of the Phase 2 Explore-CKD trial and recognition of the pivotal Phase 3 Launch-HTN trial in the “Best of the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine (NEJM)” session.

“The presentations at ASN Kidney Week demonstrated the breadth and strength of lorundrostat’s clinical program. As previously announced, the compelling results from multiple trials in this program have positioned us well for the planned filing of a New Drug Application to the FDA in the fourth quarter of 2025 or the first quarter of 2026,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “In Explore-CKD, lorundrostat reduced both blood pressure and albuminuria in participants with chronic kidney disease. We are pleased that the significant and consistent blood pressure reduction previously reported with lorundrostat in the Launch-HTN trial was selected for the “Best of JAMA” presentation at ASN’s Kidney Week 2025. With consistent benefits across blood pressure and kidney outcomes, lorundrostat is uniquely positioned to address the growing burden of cardio-renal-metabolic disease.”

Late-breaking presentation on the Explore-CKD trial (NCT06150924) of lorundrostat 25 mg once daily added to standard-of-care therapy, including sodium-glucose cotransporter-2 (SGLT2) inhibitors, demonstrated statistically significant and clinically meaningful reductions in blood pressure and albuminuria in participants with uncontrolled hypertension and CKD at four weeks of treatment. The trial met its primary endpoint, showing a reduction of 9.3 mmHg in automated office systolic blood pressure (AOSBP), and a placebo adjusted reduction of 7.5 mmHg (p-value=0.0024) at week four. Lorundrostat also achieved a reduction in spot urinary albumin-to-creatinine ratio (UACR), a marker of kidney protection, of 25.6% placebo-adjusted reduction (p=0.0015) at week four.

In Explore-CKD, lorundrostat demonstrated a favorable safety and tolerability profile. Serious adverse events occurred in two participants (3%) during lorundrostat treatment and none on placebo. Discontinuations due to treatment-emergent adverse events occurred in two participants (3%) during the lorundrostat treatment period and one participant (2%) during the placebo treatment period.

“These results are important because they show that lorundrostat, when added to standard-of-care therapy, reduced both blood pressure and proteinuria in patients with hypertension and chronic kidney disease,” said Dr. Matthew Weir, Director of the Division of Nephrology at the University of Maryland Medical Center, Professor of Medicine at the University of Maryland School of Medicine, and a scientific consultant to Mineralys Therapeutics. “The parallel reductions in systolic blood pressure and albuminuria underscore the potential of lorundrostat to improve cardio-renal outcomes in this high-risk population.”

In addition, the pivotal Phase 3 Launch-HTN trial was recognized in ASN’s “Best of JAMA and NEJM” session following publication earlier this year in JAMA. Lorundrostat demonstrated a statistically significant 16.9 mmHg absolute reduction in systolic blood pressure (SBP) at week 6 (9.1 mmHg placebo-adjusted, p<0.0001) and a 19 mmHg reduction in SBP at week 12 (11.6 mmHg placebo-adjusted, p<0.0001) in participants with uncontrolled and resistant hypertension, with a blood pressure-lowering effect observed as early as 2 weeks.

“Across trials, lorundrostat showed efficacy in diverse and difficult-to-treat patient groups, including those with confirmed uncontrolled and resistant hypertension, chronic kidney disease, obesity, and in Black or African American participants. Launch-HTN results demonstrated that lorundrostat lowers blood pressure with a persistent, clinically meaningful benefit a full 24-hours following administration,” said Dr. Manish Saxena, MBBS, Hypertension Specialist and Clinical Co-Director at William Harvey Heart Centre, Barts Health NHS Trust and QMUL. “Taken together with Advance-HTN and Explore-CKD, these results show lorundrostat has broad clinical potential across some of the most challenging patient populations.”

Lorundrostat continues to be evaluated in the ongoing Transform-HTN open-label extension study, which is assessing long-term safety and durability of response. The Company also completed enrollment in Explore-OSA, the first trial to evaluate lorundrostat in participants with hypertension and moderate-to-severe obstructive sleep apnea (OSA). Lorundrostat is the only ASI being studied to address both apnea-hypopnea index (AHI) and nighttime systolic blood pressure in this population, with data anticipated in the first quarter of 2026.

About Explore-CKD

The Explore-CKD trial (NCT06150924) was a randomized, double-blind, placebo-controlled, two-period, two-sequence (2×2) crossover trial. This Phase 2 trial was designed to evaluate BP reduction and safety of 25 mg QD lorundrostat when added to background treatment with an ACEi or ARB and an SGLT2 inhibitor for the treatment of hypertension in subjects with CKD subjects with an estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 and albuminuria (UACR of 200-5,000 mg/g). The primary efficacy endpoint of the trial was change from baseline in systolic BP at week four in the active versus placebo treatment period. Exploratory endpoints included change from baseline in UACR and eGFR at week four in the active versus placebo treatment period.

About Chronic Kidney Disease (CKD)

CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than 10% of the global population and is one of the leading causes of mortality worldwide. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 1-in-7 (approximately 37 million) U.S. adults have CKD, and approximately 22 million people in the United States are living with both hypertension and CKD. The relationship between these conditions is tightly linked: sustained hypertension may contribute to impaired kidney function, and progressive decrease in kidney function may lead to worsening BP control. When CKD is present in patients with hypertension, the risk of cardiovascular disease and mortality rises significantly.

Emerging evidence points to dysregulated aldosterone as a key driver of both diseases. Excess aldosterone promotes sodium retention, vascular inflammation, and fibrosis, contributing to both uncontrolled BP and kidney injury. Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated. Early detection and targeted interventions that address underlying mechanisms, such as aldosterone dysregulation, may offer the potential to slow CKD progression, reduce cardiovascular risk, and improve long-term outcomes. Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation.

About Launch-HTN

Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic blood pressure at six weeks versus placebo, measured by automated office blood pressure monitoring.

About Hypertension

Having sustained, elevated blood pressure (or hypertension) (BP) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.

Less than 50% of hypertension patients achieve their BP goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.

About Lorundrostat

Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants.

The Company has now completed four successful clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The Company has completed two pivotal, registrational trials, including the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.

About Mineralys

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky.

Forward Looking Statements

Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company’s expectation that aldosterone synthase inhibitors with an SGLT2 inhibitor may provide additive clinical benefits to patients; the Company’s expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA); the anticipated timing of NDA submission and the FDA’s review of the same; the Company’s ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; the planned future clinical development of lorundrostat and the timing thereof; and the expected timing of commencement and enrollment of participants in clinical trials and topline results from clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; any delays in the FDA’s review of our planned NDA submission, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:

Investor Relations
investorrelations@mineralystx.com

Media Relations
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com

AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets Demonstrate Positive Real-world Impact, with Patients Reporting Improvement in Involuntary Movements and Activities of Daily Living




AUSTEDO® (deutetrabenazine) tablets and AUSTEDO XR® (deutetrabenazine) extended-release tablets Demonstrate Positive Real-world Impact, with Patients Reporting Improvement in Involuntary Movements and Activities of Daily Living

• In a new cohort of 27 adults from the IMPACT-TD Registry, up to 77% of participants reported improvements in aspects of their lives impacted by tardive dyskinesia (TD) while taking AUSTEDO or AUSTEDO XR
• Most (85%) participants taking AUSTEDO or AUSTEDO XR in conjunction with their mental health medications reported that their mental health condition remained stable or improved
• Teva is committed to truly understanding and empowering individuals living with TD to help improve their TD and regain their independence

PARSIPPANY, N.J., and TEL AVIV, Israel, Nov. 07, 2025 (GLOBE NEWSWIRE) — Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the presentation of new data from the ongoing, real-world IMPACT-TD Registry. The findings demonstrate that treatment with AUSTEDO (deutetrabenazine) tablets or AUSTEDO XR (deutetrabenazine) extended-release tablets for tardive dyskinesia (TD) led to reductions in the severity of involuntary movements and improvements in patient-reported quality of life. The data were presented at the 2025 Neuroscience Education Institute Fall Congress, taking place November 6 – 9, 2025 in Colorado Springs, Colorado.

“The silent struggle of tardive dyskinesia, with its relentless, involuntary movements, can deprive patients of their quality of life and independence—real-world findings are so critical to inform how we innovate and improve the everyday lives of individuals living with this disease,” said Stacy Finkbeiner, Senior Medical Director, Movement Disorders & Psychiatry at Teva. “These data articulate patient experience and further validate clinical research showing how AUSTEDO or AUSTEDO XR can help people living with tardive dyskinesia improve their symptoms while maintaining their mental health, something we care deeply about in our mission at Teva to improve the lives of patients.”

The interim analysis of the IMPACT-TD Registry, a Phase 4 study, evaluated 27 adults with TD treated with AUSTEDO or AUSTEDO XR after a three-month period using IMPACT-TD PRO, a 30-question scale measuring patient-reported impact across 5 key areas. The study included patients with common comorbid psychiatric disorders, such as bipolar disorder (41%), anxiety disorder (37%), depression (26%), and schizophrenia (19%), reflecting a diverse, real-world patient population.

Key results revealed:

• Patient-reported meaningful improvement after three months on AUSTEDO or AUSTEDO XR across several areas, including speech/communication (77%), eating (75%), psychosocial impact (65%), activities of daily living (59%), and sleep/pain (50%).
• At three months, the total motor score on the Abnormal Involuntary Movement Scale (AIMS) showed a mean decrease of -2.9, indicating a notable reduction in the severity of uncontrolled movements consistent with what was previously seen in pivotal trials.
• Most (85%) participants taking AUSTEDO or AUSTEDO XR in conjunction with their mental health medications reported that their underlying mental health condition remained stable or improved based on the Patient Global Impression of Severity (PGIS) scale.

While Part A of the IMPACT-TD Registry demonstrated the broad impact TD has on individuals beyond physical movements, these initial findings from Part B reflect patient-reported improvements in everyday tasks like speaking, eating, and other activities of daily living as a result of movement reduction with AUSTEDO or AUSTEDO XR.

About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD) is a highly debilitating, chronic movement disorder that affects one in four people who take certain mental health treatments and is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals.^1,2,3

About AUSTEDO XR Extended-Release Tablets and AUSTEDO Tablets
AUSTEDO XR and AUSTEDO are the first vesicular monoamine transporter 2 (VMAT2) inhibitors approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.

INDICATIONS AND USAGE
AUSTEDO XR (deutetrabenazine) extended-release tablets and AUSTEDO (deutetrabenazine) tablets are indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION 

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO XR and AUSTEDO are contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression. 

Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO XR and AUSTEDO are also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine or valbenazine.   

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO XR and AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO XR or AUSTEDO in their patients by assessing the effect on chorea and possible adverse effects. 

QTc Prolongation: AUSTEDO XR and AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO XR or AUSTEDO is administered within the recommended dosage range. AUSTEDO XR and AUSTEDO should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.  

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.   

Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. 

Parkinsonism: AUSTEDO XR and AUSTEDO may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO XR or AUSTEDO dose should be reduced; some patients may require discontinuation of therapy. 

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO XR and AUSTEDO. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO XR or AUSTEDO and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence. 

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO XR and AUSTEDO.   

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects. 

Common Adverse Reactions: The most common adverse reactions for AUSTEDO (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.  Adverse reactions with AUSTEDO XR extended-release tablets are expected to be similar to AUSTEDO tablets. 

Please see accompanying full Prescribing Information, including Boxed Warning. 

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Teva Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AUSTEDO and AUSTEDO XR for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

References:

1. Warikoo N, Schwartz T, Citrome L. Tardive dyskinesia. In: Schwartz TL, Megna J, Topel ME, eds. Antipsychotic Drugs. Hauppauge, NY: Nova Science Publishers. 2013:235-258.
2. Waln O, Jankovic J. An Update on Tardive Dyskinesia: From Phenomenology to Treatment. Tremor Other Hyperkinet Mov. 2013;3:1-11.
3. Tardive dyskinesia. National Alliance on Mental Illness website. https://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Tardive-Dyskinesia. Accessed May 4, 2023.

Evaxion presents new immune data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01




Evaxion presents new immune data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01

• New biomarker and immune data presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting
• Following the recent presentation of unprecedented two-year clinical efficacy data from the phase 2 trial, the new data further adds to EVX-01’s already strong data package

COPENHAGEN, Denmark, November 7, 2025 – Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces new data exploring immune responses following treatment with AI-designed personalized cancer vaccine EVX-01. The data was presented today in a poster session at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting taking place in National Harbor, Maryland.

Developed with Evaxion’s AI-Immunology™ platform, EVX-01 is designed to target multiple neoantigens – cancer unique proteins arising from mutations – and to induce a clinically relevant immune response. The new biomarker and immune data stems from the phase 2 trial evaluating EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer).

Longitudinal patient blood samples were collected before, during and after treatment to unravel treatment-induced changes in specific immune cell populations. More specifically, circulating T-cell subsets were characterized aiming at increasing the understanding of the immune responses induced by EVX-01. In subsets of analyzed patients, clinical responses were accompanied by a rapid and sustained induction of EVX-01-specific T-cells.

“We are pleased with the opportunity to present these exploratory translational data at a conference as important as SITC as we continue to add to EVX-01’s strong data package. Having presented the two-year clinical efficacy data from the phase 2 trial just last month at the European Society for Medical Oncology 2025 congress, we are encouraged by the interest in EVX-01 from the medical community”, says Birgitte Rønø, CSO and interim CEO of Evaxion.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Contact information 
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai

About Evaxion
Evaxion is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website.

Forward-looking statement 
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.