Latest news with #biomarkers
The Australian
3 days ago
- Health
- The Australian
Alterity reports positive trial results
Special Report: Alterity Therapeutics has reported positive topline results from its open-label phase II clinical trial of lead drug ATH434, offering encouraging signs for the treatment of multiple system atrophy (MSA). Alterity reports positive topline data from open-label phase II trial of ATH434 in multiple system atrophy ATH434 demonstrated clinical benefit on Unified MSA Rating Scale and global measures of neurological symptoms Neuroimaging biomarkers showed target engagement and slowed brain atrophy with drug well tolerated and having a favourable safety profile The study, conducted in a patient population with more advanced disease than in the Alterity Therapeutics' (ASX:ATH) double-blind phase II trial, showed ATH434 was well tolerated and provided measurable clinical benefits, including stabilisation of neurological symptoms and slowed brain atrophy. Over the 12-month treatment period, results indicated patients treated with ATH434 showed ~50% less disease progression on the Modified Unified MSA Rating Scale (UMSARS I) compared to historical controls. Notably, 30% of participants reported stable or improved symptoms – an uncommon result in this advanced patient group. In further encouraging results, 30% of participants also stabilised or improved on the Patient Global Impression of Change (PGIC) scale, which asks the patient to evaluate their overall neurological symptoms as compared to immediately before starting therapy. ATH434 also helped stabilise symptoms of orthostatic hypotension, a common and serious drop in blood pressure when standing, in study participants. Notably, the overall results suggest that ATH434 was just as effective in this more advanced group of MSA patients as it was in earlier-stage patients from the previous phase II double-blinded trial. Neuroimaging data provided further support, showing a slowing of brain volume loss in MSA-affected regions and reduced iron accumulation – both consistent with the proposed mechanism of ATH434, which targets excess brain iron thought to drive MSA pathology. Novel approach could provide much-needed therapy Alterity's lead indication, MSA, is a rare and aggressive parkinsonian disorder with up to 50,000 patients in the US, driven by excess iron and aggregation of a protein called alpha-synuclein in the central nervous system. ATH434 takes a novel approach to MSA by addressing iron imbalance and protein aggregation, offering what could be the first disease-modifying therapy. The drug has been granted both fast track and orphan drug designations by the US Food and Drug Administration, as well as orphan drug status in the EU. Backed by promising phase II and open-label phase II results, Alterity is chasing a market opportunity exceeding US$1.1 billion with ATH434. About the open-label study The phase II open label trial (ATH-434-202) was an open-label study in advanced MSA. The trial enrolled participants diagnosed with MSA using a multimodal approach (clinical, neuroimaging, fluid biomarkers), who were treated with oral ATH434 75mg twice daily for 12 months. The study assessed the safety and efficacy of ATH434 treatment on clinical and biomarker endpoints. The pre-specified key clinical endpoints included the modified UMSARS I, the clinical global impression of change, and the patient global impression of change. Enrolled participants were more advanced than those in the double-blind ATH434-201 phase II trial based on baseline variables including duration of motor symptoms, UMSARS I score, frequency of severe orthostatic hypotension, and plasma NFL levels. Based on the observed clinical and neuroimaging data, ATH434 improved overall neurological symptoms and slowed disease progression compared to historical data. 'Strongly support advancing our ATH434 program' CEO Dr David Stamler said he was very encouraged by the positive results from the ATH434-202 trial, as they reinforce the robust efficacy we observed in its phase II study. 'The data from our phase II studies are consistent and strongly support advancing our ATH434 program in MSA,' he said. 'With the favourable clinical and biomarker outcomes we have seen, we continue to believe that ATH434 has the potential to slow the progression of this devastating disease. 'We are committed to bringing this new therapy to patients as soon as possible.' The trial's lead investigator, professor Daniel Claassen from Vanderbilt University Medical Centre said the results were very helpful in establishing the clinical response to therapy. He said the consistent changes in UMSARS, along with quantitative measures in imaging, support the findings noted in the phase II trial. 'Currently, there are no disease modifying medications for the treatment of MSA, and these data encourage the continued development of ATH434 to treat this disease,' he said. 'We are indebted to the study participants and their families who contributed to this study.' This article was developed in collaboration with Alterity Therapeutics, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
National Post
3 days ago
- Business
- National Post
Quanterix Launches Novel p-Tau 205 and p-Tau 212 Assays to Advance Alzheimer's Research at AAIC
Article content Company highlights expanded capabilities following Akoya Biosciences Acquisition and Simoa ® technology included in more than 55 posters and oral presentations at the annual conference demonstrating its impact on neurodegenerative disease research Article content BILLERICA, Mass. — Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced the first to market, commercial launch of two novel phospho-tau assays: p‑Tau 205 and p‑Tau 212, expanding its market-leading portfolio of blood-based biomarkers for Alzheimer's disease and neurodegeneration. The announcement comes alongside Quanterix's robust presence at the Alzheimer's Association International Conference (AAIC) 2025, with more than 55 posters and presentations featuring data generated using its Simoa ® technology. Article content These new assays enable the precise detection of tau phosphorylation sites, biomarkers increasingly associated with early and progressive stages of Alzheimer's disease. Developed on Quanterix's ultra-sensitive Simoa ® platform, our p‑Tau 205 and 212 assays empower researchers to explore novel disease mechanisms, refine patient stratification, and support therapeutic development through fluid-based biomarkers. Article content Quanterix's growing leadership in neurobiology was further reinforced by its recent acquisition of Akoya Biosciences, bringing advanced spatial proteomics into its scientific ecosystem. The Human FFPE Neurobiology Panel, originally developed by Akoya, complements the Simoa ® platform by enabling high-plex, spatially resolved analysis of disease-specific protein expression in brain tissue. Together, these platforms offer researchers a powerful combination of tissue- and fluid-based biomarker discovery to accelerate translation from bench to bedside. Article content 'The addition of p‑Tau 205 and 212 strengthens our ability to support the scientific community in its pursuit of earlier detection, deeper understanding, and more personalized treatment approaches for Alzheimer's,' said Masoud Toloue, PhD, CEO of Quanterix. 'Combined with the recent integration of Akoya's spatial biology platform, we are now uniquely positioned to offer researchers a multi-dimensional view of pathobiology—bridging the gap between soluble protein dynamics and spatial tissue context. By uniting two best-in-class technologies, we're advancing the future of precision diagnostics across neurology, oncology, and immunology.' Article content The newly launched p-Tau 205 and p-Tau 212 assays are now available to customers for use on the HD-X or SR-X instruments or testing directly through Quanterix's in-house Accelerator Lab, a CLIA-licensed, ISO 15189-accredited facility providing contract biomarker testing services to global partners in pharma, biotech, and academia. Article content To learn more about the new assays or Quanterix's expanded capabilities, visit or stop by the Quanterix booth at AAIC 2025. Article content About Quanterix Article content Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa ® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company ®, adding multiplexed tissue imaging with single-cell resolution to its portfolio and 1,396 installed instruments. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics. Learn more at Article content Article content Article content Article content Contacts Article content Media Contact: Marissa Klaassen (781) 913.8036 media@ Article content
Globe and Mail
4 days ago
- Business
- Globe and Mail
Bayer AG's Exploratory Study on Sepsis and DIC: A Potential Game-Changer?
Bayer AG ((BAYRY)), Bayer Ag (UK) ((GB:0P6S)) announced an update on their ongoing clinical study. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Bayer AG is conducting an exploratory study titled 'Exploratory Study to Investigate the Association Between the Onset of Disseminated Intravascular Coagulation (DIC) and Disease Progression With Different Biomarker Candidates as Well as Standard Clinical and Demographic Parameters in Adult Patients With Sepsis.' The study aims to understand how sepsis progresses to DIC, a severe blood disorder, by identifying biomarkers in patients admitted to intensive care units across Europe. This research is significant due to the limited treatment options for DIC, especially in sepsis patients. The study involves no investigational treatments; instead, participants receive standard medical care for sepsis. The focus is on collecting blood samples and clinical data to identify biomarkers indicative of DIC development. Designed as an interventional study with a single-group model, this research does not involve masking and primarily seeks to gather observational data. The study's primary purpose is to explore the progression of sepsis to DIC. The study began on January 29, 2025, with primary completion expected within 56 days for each participant. The latest update was submitted on July 22, 2025, indicating ongoing recruitment and data collection. This study could impact Bayer's stock performance by potentially enhancing its reputation in the medical research field, especially if the findings lead to improved understanding and treatment of sepsis-related DIC. Investors may view this as a positive development, although the absence of new drug interventions limits immediate commercial implications. The study is ongoing, with further details available on the ClinicalTrials portal.
Yahoo
23-07-2025
- Business
- Yahoo
Next-Generation Sequencing Enhancing Accuracy, Precision Medicine Advancements Propel Growth
The global companion diagnostics market is set to surge from USD 7.03 Billion in 2024 to USD 22.83 Billion by 2034, driven by rising cancer prevalence and precision medicine advancements. Key trends include enhanced diagnostic technologies like NGS and PCR, regulatory approvals, and growing targeted therapies demand. Companion Diagnostics Market Dublin, July 23, 2025 (GLOBE NEWSWIRE) -- The "Companion Diagnostics Market Report and Forecast 2025-2034" report has been added to global companion diagnostics market was valued at USD 7.03 Billion in 2024, driven by the rising prevalence of cancer across the globe. The market is anticipated to grow at a CAGR of 12.50% during the forecast period of 2025-2034 to achieve a value of USD 22.83 Billion by 2034. Companion diagnostic tests help in the diagnosis of diseases and determines the most effective drug for a specific patient. These tests are crucial in cancer treatment, identifying biomarkers that indicate a patient's suitability for individualised treatment. Pharmaceutical companies integrate companion diagnostics into drug development to enhance efficacy, ensuring that only patients most likely to benefit receive targeted global companion diagnostics market is witnessing robust growth due to advancements in precision medicine and increasing demand for targeted therapies. Rising cancer prevalence, the need for biomarker-based diagnostics, and regulatory support for new test approvals drive market expansion. Moreover, the growing adoption of next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies further enhances diagnostic accuracy, enabling personalised treatment Drivers and Adoption TrendsThe companion diagnostic market is expanding due to rising demand for precision cancer treatments. Companies like Foundation Medicine lead innovations with products like FOUNDATIONONE CDx, which analyses cancer-related genes in solid tumors. Increasing regulatory approvals and advancements in companion diagnostic tests further support market growth. The rising prevalence of cancer has prompted greater adoption of companion diagnostics, ensuring effective treatment Approvals and COVID-19 ImpactThe U.S. FDA is approving novel companion diagnostic (CDx) tests, such as the Oncomine Dx Target Test by Thermo Fisher Scientific Inc., designed to detect HER2 (ERBB2) activating mutations in non-small cell lung cancer. However, the COVID-19 pandemic initially reduced demand for companion diagnostics products, delaying novel diagnostic tests. Despite this, the global companion diagnostics market is expected to recover and expand significantly during the forecast Companion Diagnostics Market TrendsExpanding IndicationsThe market is broadening beyond oncology to include neurological, cardiovascular, and infectious diseases. Regulatory approvals for new indications enable the development of biomarker-driven therapies, improving patient outcomes. This trend enhances diagnostic applications, supporting pharmaceutical innovations and expanding the market's potential across diverse therapeutic on Precision MedicineThe shift towards precision medicine is driving the demand for companion diagnostics, ensuring targeted drug selection. Advances in genomic profiling allow for personalised treatment plans, reducing adverse reactions and enhancing efficacy. Pharmaceutical companies increasingly integrate biomarker-based diagnostics to develop tailored therapies, improving patient care and optimising treatment Healthcare ExpendituresIncreasing healthcare investments globally support the growth of companion diagnostics, with governments and private entities funding research and development. The demand for early disease detection and advanced diagnostics drives higher spending, ensuring improved diagnostic capabilities and expanding access to innovative treatments, particularly in emerging in TechnologiesCutting-edge technologies like next-generation sequencing (NGS), artificial intelligence (AI), and digital pathology enhance the efficiency of companion diagnostics. Automated platforms enable faster, more accurate biomarker detection, supporting precision medicine. Continuous innovation in diagnostic tools strengthens the market, improving patient outcomes through highly specialised, data-driven Diagnostics Market Growth Factors Rising Cancer Incidence to Drive the Demand for Companion DiagnosticsThe increasing global burden of cancer is a key factor propelling the growth of the companion diagnostics market. According to the American Cancer Society, cancer cases are projected to reach 35 million by 2050, primarily due to population growth and ageing demographics. This surge in cases necessitates advanced diagnostic solutions for early detection, effective treatment, and improved patient outcomes. Companion diagnostics play a crucial role in guiding targeted therapies, ensuring personalised treatment strategies, and enhancing the efficacy of cancer technological advancements such as next-generation sequencing (NGS) and liquid biopsy techniques have further bolstered market expansion. These innovations facilitate rapid genetic profiling, helping oncologists identify specific biomarkers associated with different cancer types. The rising adoption of precision medicine by healthcare providers and pharmaceutical companies is also a significant growth driver. As demand for customised cancer treatments increases, the market for companion diagnostics is expected to expand Approvals for Novel Diagnostic Tests to Fuel Market ExpansionThe approval of new companion diagnostic tests for various indications is another critical factor driving market growth. Regulatory bodies such as the U.S. FDA, European Medicines Agency (EMA), and other global health authorities continue to approve innovative diagnostic solutions for targeted therapies. These approvals validate the clinical efficacy of companion diagnostics, increasing their adoption across healthcare facilities. The expanding pipeline of biomarker-driven therapies further encourages diagnostic companies to develop novel tests, contributing to overall market regulatory support ensures that new diagnostics meet stringent safety and accuracy standards, enhancing physician confidence in their effectiveness. Recent approvals of companion diagnostic assays for lung, breast, and colorectal cancers have provided patients with access to personalised treatment options. As pharmaceutical firms continue to collaborate with diagnostic developers, the market is poised for sustained growth, driven by innovation and regulatory Factors Challenges in Reimbursement Policies and Strict Regulatory Requirements Hindering Market GrowthThe companion diagnostics market faces significant challenges due to complex reimbursement policies. Many healthcare systems lack well-defined reimbursement frameworks for companion diagnostic tests, making it difficult for patients and healthcare providers to afford these tests. The high cost of developing and validating these diagnostics further complicates accessibility, limiting their widespread adoption. Additionally, variations in reimbursement policies across different countries create inconsistencies in market regulatory requirements act as another major barrier, as companion diagnostics must undergo rigorous approval processes to ensure accuracy and efficacy. Regulatory bodies such as the U.S. FDA, EMA, and other global agencies enforce strict guidelines, leading to prolonged approval timelines. Compliance with these complex regulations requires substantial investment and expertise, delaying market entry for new high cost of companion diagnostics is another critical factor restricting market expansion. Next-generation sequencing (NGS) and polymerase chain reaction (PCR) technologies involve expensive equipment and specialised expertise, making these diagnostics unaffordable for many healthcare institutions. The financial burden on smaller laboratories and emerging markets further limits accessibility, restricting the overall growth of the limited awareness and adoption rates in developing regions pose additional challenges. A lack of trained professionals, inadequate infrastructure, and limited integration of precision medicine hinder the widespread implementation of companion diagnostics. Addressing these barriers requires increased investment in education, regulatory simplifications, and improved reimbursement models to unlock the market's full potential. Key Industry Developments In October 2024, Roche secured FDA approval for its VENTANA Claudin 18 (43-14A) RxDx Assay, making it the first immunohistochemistry (IHC) companion diagnostic for CLDN18 protein expression in gastric and gastroesophageal junction adenocarcinoma patients. This breakthrough enabled eligible patients to receive Astellas' targeted therapy VYLOY (zolbetuximab), enhancing treatment precision in gastrointestinal cancers. In August 2024, Illumina, Inc. announced FDA approval of its TruSightT Oncology (TSO) Comprehensive test, a single in vitro diagnostic (IVD) that can profile over 500 genes in solid tumors. This test is designed to identify both adult and pediatric patients with solid tumors that have neurotrophic tyrosine receptor kinase (NTRK) gene fusions. If the test detects this, the patient may benefit from Bayer's VITRAKVI (larotrectinib). The test is also approved for identifying adult patients with advanced or metastatic non-small-cell lung cancer (NSCLC) that has rearranged during transfection (RET) gene fusions. These patients may benefit from treatment with Lilly's RETEVMO (selpercatinib). In August 2024, QIAGEN expanded its collaboration with AstraZeneca to develop companion diagnostics (CDx) for chronic diseases. Using QIAGEN's QIAstat-Dx platform, the partnership aimed at create a genotyping assay that facilitates real-time patient screening, helping healthcare providers determine patient eligibility for AstraZeneca's genomically targeted medicines, ultimately improving treatment accessibility and clinical decision-making. In July 2024, BD and Quest Diagnostics entered a global collaboration to develop flow cytometry-based companion diagnostics (CDx) for cancer and other diseases. This partnership aimed at providing an end-to-end CDx solution pharmaceutical companies. It ranged from exploratory panel development to FDA-approved diagnostic kit distribution, so as to advance precision medicine for better treatment selection. Key Attributes: Report Attribute Details No. of Pages 400 Forecast Period 2025 - 2034 Estimated Market Value (USD) in 2025 $7.03 Billion Forecasted Market Value (USD) by 2034 $22.83 Billion Compound Annual Growth Rate 12.5% Regions Covered Global Supplier Landscape Abbott F. Hoffmann-La Roche Ltd. Agilent Technologies, Inc. Illumina, Inc. Guardant Health Thermo Fisher Scientific Inc. BIOMERIEUX QIAGEN Myriad Genetics, Inc. Global Companion Diagnostics Market SegmentationMarket Breakup by Offerings Products Assays, Kits and Reagents Instruments & Systems Software Services Market Breakup by Technology Polymerase Chain Reaction Immunohistochemistry In Situ Hybridization Next-Generation Sequencing Others Market Breakup by Indication Cancer Neurological Diseases Infectious Diseases Others Market Breakup by End User Pharmaceutical & Biopharmaceutical Companies Reference Laboratories Contract Research Organizations Others Market Breakup by Region North America Europe Asia Pacific Latin America Middle East and Africa For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Companion Diagnostics Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Yahoo
22-07-2025
- Health
- Yahoo
NewAmsterdam Pharma to Present Alzheimer's Biomarker Data from BROADWAY Trial at AAIC 2025
– NewAmsterdam to host conference call at 10:00 a.m. ET on Wednesday, July 30th – NAARDEN, the Netherlands and MIAMI, July 22, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or 'NewAmsterdam' or the 'Company'), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that it will present full data from the prespecified Alzheimer's Disease (AD) biomarker analyses in the BROADWAY clinical trial (NCT05142722) in a late-breaking oral presentation at the Alzheimer's Association International Conference (AAIC), being held July 30, 2025 in Toronto, Canada. Details of the presentation are as follows: Presentation Title: Effects of Obicetrapib, a Potent Oral CETP Inhibitor, on Alzheimer's Disease Biomarkers in 1727 Patients with Cardiovascular DiseaseSession Title: Developing Topics on Innovative Therapeutic ApproachesPresentation Date and Time: Wednesday, July 30, 2025, 8:21-8:28 AM ETPresenter: Philip Scheltens M.D., Room 718 Conference Call and Webcast Information NewAmsterdam will host a live webcast and conference call at 10:00 a.m. ET on July 30, 2025 to review the full AD biomarker data presented at AAIC. The call will include remarks from featured speakers including: Philip Scheltens, M.D., Ph.D., professor of Neurology at the Vrije Universiteit Amsterdam and partner and head of EQT Life Sciences Dementia Fund; Kellyann Niotis, M.D., director of Parkinson's and Lewy Body Dementia Research at The Institute for Neurogenerative Diseases - Parkinson's and Alzheimer's Research Education Foundation; and Nathaniel Chin, M.D., medical director and Clinical Core Co-Leader for the Wisconsin Alzheimer's Disease Research Center (ADRC) and medical director for the Wisconsin Registry for Alzheimer's Prevention (WRAP). To access the live webcast, participants may register here. The live webcast will be available under the 'Events & Presentations' section of the Investor Relations page of the Company's website at To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archived replay of the webcast will be available on NewAmsterdam's website following the live event. About ObicetrapibObicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company's Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company's Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company. About NewAmsterdamNewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage, clinical biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company ContactMatthew PhilippeP: Media ContactReal Chemistry on behalf of NewAmsterdamChristian EdgingtonP: 1-513-310-6410cedgington@ Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
