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YD Bio Business Partner EG Biomed Achieves CAP Accreditation, Advancing U.S. Clinical Testing Capabilities
Globenewswire· 2025-10-10 12:37
Core Insights - YD Bio Limited announced that its partner EG Biomed US Inc. has received accreditation from the College of American Pathologists, enhancing its capabilities in cancer detection and diagnostics [1][2][3] Group 1: Company Achievements - EG BioMed's CAP accreditation confirms its adherence to high standards in laboratory operations, which supports YD Bio's cancer detection programs [2] - The accreditation positions YD Bio and EG BioMed to expand their diagnostic portfolio, particularly in early cancer detection and monitoring [3] Group 2: Scientific Advancements - Ruo-Kai Lin, Chief R&D Officer of EG BioMed, presented new findings on a novel circulating cell-free DNA biomarker at the AACR conference, which could aid in monitoring advanced pancreatic cancer [4] Group 3: Company Overview - YD Bio Limited focuses on clinical trials, new drug development, cancer prevention diagnostics, and therapies for diseases with high unmet medical needs, aiming to improve patient outcomes through scientific innovation [5]
Abeona Therapeutics® and Children's Hospital Colorado Announce Newest Treatment Center for ZEVASKYN® Gene Therapy
Globenewswire· 2025-10-08 11:30
Core Insights - Abeona Therapeutics has activated Children's Hospital Colorado as a Qualified Treatment Center for ZEVASKYN, a gene-modified therapy for recessive dystrophic epidermolysis bullosa (RDEB) [1][2] - ZEVASKYN is the first FDA-approved therapy for treating wounds in RDEB patients, offering a long-lasting treatment option and improved quality of life [2][5] - The collaboration aims to broaden access to ZEVASKYN across a network of established epidermolysis bullosa centers [2] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being its flagship product [11] - The company operates a cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [11] Product Details - ZEVASKYN (prademagene zamikeracel) is an autologous cell sheet-based gene therapy designed to treat wounds in both adult and pediatric patients with RDEB [6][5] - The therapy incorporates the COL7A1 gene into a patient's skin cells to produce functional type VII collagen, which is essential for skin integrity [5][6] - Clinical results have shown meaningful wound healing and pain reduction with a single application of ZEVASKYN [5] Clinical and Research Context - Children's Hospital Colorado is recognized as a center of excellence for epidermolysis bullosa and is part of the EB Clinical Research Consortium, contributing to advanced research and treatment options [2][10] - The hospital's Precision Medicine Institute supports innovative treatments by utilizing patients' unique genetic information [2] Patient Support Services - Abeona offers a comprehensive patient support program called Abeona Assist, which helps patients navigate insurance benefits, financial assistance, and logistical support for treatment [3]
5 Biotech Stocks Worth Adding to Your Portfolio Now
ZACKS· 2025-09-23 14:25
Industry Overview - The biotech industry has shown resilience in 2025 despite ongoing geopolitical tensions and tariff threats, with significant investments in U.S. manufacturing by major pharma and biotech companies [1] - The Zacks Biomedical and Genetics industry includes biopharmaceutical and biotechnology firms that develop innovative drugs using advanced technology [4] - The industry is currently ranked 102 by Zacks, placing it in the top 41% of over 246 Zacks industries, indicating a decent outlook driven by consistent demand for medical treatments [15] Mergers and Acquisitions - 2025 has experienced a surge in mergers and acquisitions, particularly focused on AI-driven drug discovery, as companies seek to expand their product portfolios [2][9] - Notable acquisitions include Roche's purchase of 89bio, Inc. for $3.5 billion and Novartis's acquisition of Tourmaline Bio for $1.4 billion, highlighting a trend towards portfolio expansion in response to changing market dynamics [10] Company Performance - Biotech companies such as Halozyme Therapeutics, Akero Therapeutics, Kiniska Pharmaceuticals, ANI Pharmaceuticals, and Twist BioScience are positioned to outperform the sector [3] - Halozyme Therapeutics has seen a 63.8% increase in shares year-to-date, with a Zacks Consensus Estimate for 2025 EPS rising to $6.18 [25] - Kiniska Pharmaceuticals has experienced an 82.4% share increase, with the Zacks Consensus Estimate for 2025 EPS rising to $1.03 [28] - ANI Pharmaceuticals shares have gained 73.6% this year, with earnings estimates for 2025 increasing by 84 cents [33] - Akero Therapeutics has seen a 66.8% increase in shares, focusing on treatments for metabolic diseases [36] - Twist Bioscience is expanding its technology to include synthetic RNA and antibody proteins, collaborating with Synthetic Design Lab for cancer treatments [41] Market Trends - The focus on innovation and execution is critical, with companies investing heavily in research and development to create breakthrough treatments [6] - The use of AI technology in drug discovery is expected to attract further investment in the biotech sector [11] - New drug approvals have accelerated in 2025, contributing to positive market momentum despite a challenging macro environment [11] Financial Metrics - The Zacks Biomedical and Genetics industry is trading at a trailing 12-month price-to-sales ratio of 2.16X, compared to the S&P 500's 5.95X and the Zacks Medical sector's 2.40X [20] - The industry's stock performance has gained 6% year-to-date, outperforming the Zacks Medical sector, which declined by 0.5% [17]
Tempus AI Enhances Cancer Research Tools With FDA-Cleared xR IVD
ZACKS· 2025-09-23 13:35
Core Insights - RNA sequencing offers a comprehensive view of biological information, enhancing understanding of disease mechanisms and improving fusion detection [1] - Tempus AI has received FDA clearance for its xR IVD device, which utilizes RNA-based insights to support drug development [2][8] - The xR IVD assay is a next-generation sequencing-based diagnostic tool that detects gene rearrangements in tumor tissues from patients with solid malignancies [3] - Tempus' xR IVD device is part of its broader strategy to advance oncology therapeutic research and development, reinforcing its position in precision medicine [4] Company Updates - Tempus AI's stock has increased by 55.1% over the past year, outperforming the industry growth of 22.7% and the S&P 500's 18.7% [7] - The current forward Price-to-Sales (P/S) ratio for Tempus AI is 10.16X, significantly higher than the industry average of 5.59X, indicating an expensive valuation [9] Peer Updates - Illumina is expanding its NGS oncology portfolio with the TruSight Oncology assay, TSO 500, which is gaining broader adoption and reimbursement [5] - QIAGEN is enhancing its Digital Insights business with AI integration and new QIAseq panels for comprehensive genomic profiling [6]
Myriad Genetics and SOPHiA GENETICS to Develop an Innovative Companion Diagnostic Offering in Liquid Biopsy
Prnewswire· 2025-09-23 12:01
Core Insights - Myriad Genetics and SOPHiA GENETICS have announced a strategic collaboration to develop a global liquid biopsy companion diagnostic test for pharmaceutical companies [1] Company Overview - Myriad Genetics is recognized as a leader in molecular diagnostic testing and precision medicine [1] - SOPHiA GENETICS is an AI technology company focused on transforming precision medicine [1] Collaboration Details - The collaboration aims to innovate and provide pharmaceutical companies with advanced diagnostic solutions [1]
Alnylam Pharmaceuticals joins Alliance for Genomic Discovery, expanding diverse clinical genomic dataset to drive precision medicine
Prnewswire· 2025-09-18 13:15
Core Insights - Alnylam Pharmaceuticals has joined the Alliance for Genomic Discovery (AGD), which aims to accelerate drug discovery through clinical genomic data [1][2][3] - The AGD dataset will enhance Alnylam's ability to identify new therapeutic targets for RNA interference (RNAi) therapeutics, which work by silencing disease-causing genes [4][5] - The AGD now includes nine members, with Alnylam being the latest addition, and plans to expand its dataset by sequencing an additional 31,250 whole genomes, building on an existing cohort of 250,000 [3][5] Company and Industry Developments - The AGD is led by Illumina and Nashville Biosciences, focusing on leveraging genomic data to drive innovation in therapeutics [2][3] - Alnylam's participation is expected to strengthen the AGD's clinical genomic database, which aims to provide diverse and representative data for drug discovery [5][6] - The alliance has already identified novel therapeutic targets, particularly in autoimmune and neurodegenerative diseases, demonstrating the dataset's value to its members [6][8] Technological Advancements - The AGD utilizes advanced sequencing and data analysis technologies, such as DRAGEN and Illumina Connected Analytics, to enhance the accuracy and speed of genomic insights [6][8] - The alliance plans to incorporate multiomic layers into its dataset, which will facilitate faster target discovery and therapy development [8] - The AGD dataset aims to link diverse genomic data with clinical phenotyping to ensure that discoveries benefit a wide range of populations [5][6]
The New Olink Target 48 Neurodegeneration Panel May Boost TMO Stock
ZACKS· 2025-09-16 15:46
Company Overview - Thermo Fisher Scientific (TMO) launched the Olink Target 48 Neurodegeneration panel, a targeted proteomics immunoassay designed to enhance neurodegenerative disease research by measuring 41 key proteins with absolute quantification from as little as 1µL of plasma sample [1][5][8] - The new panel is part of Olink's expanding portfolio of multiplex disease panels, emphasizing the company's commitment to advancing precision medicine and neurology research [2][3] Product Details - The Target 48 Neurodegeneration panel is designed to meet the increasing demand for scalable and reproducible protein measurements in the context of rising neurodegenerative diseases such as Alzheimer's and Parkinson's [5][9] - It is compatible with the Olink Signature Q100 benchtop system, facilitating a simplified workflow and minimal maintenance, which accelerates biomarker research [6][8] Market Insights - The neurodegenerative disease diagnostics market is projected to grow from $4.70 billion in 2025 at a compound annual growth rate of 7.5% through 2030, driven by the increasing prevalence of neurodegenerative disorders and advancements in diagnostic technologies [10] Financial Performance - Thermo Fisher has a market capitalization of $181.05 billion and an earnings yield of 4.7%, significantly higher than the industry's -4.2% yield [4] - Over the past three months, TMO shares have increased by 21.6%, outperforming the industry growth of 1.9% [12]
Spectral Medical Announces Publication of EDEN Observational Study
Globenewswire· 2025-09-16 11:30
Core Insights - A new study identifies endotoxic septic shock (ESS) as a distinct and high-risk form of septic shock, with a significantly higher mortality rate compared to other septic shock patients [1][2][4] - The study found that patients with ESS had a 28-day mortality rate of 57.1%, more than three times the 15.9% rate observed in other septic shock patients [2] - The findings support Spectral Medical's precision medicine approach, which combines the Endotoxin Activity Assay (EAA) diagnostic with the PMX hemoadsorption device to target high-risk patients [3][4] Company Overview - Spectral Medical Inc. is a late-stage theranostic company focused on developing therapeutic options for sepsis and septic shock, currently seeking FDA approval for its PMX device [1][6] - PMX is a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream and has been approved for use in Japan and Europe, with over 360,000 units sold globally [7] - The company has received Breakthrough Device Designation from the FDA for PMX in treating endotoxic septic shock, with approximately 330,000 patients diagnosed with septic shock annually in North America [7] Clinical Study Insights - The study titled "Organ Failure, Endotoxin Activity, and Mortality in Septic Shock" involved a multicenter observational analysis of 90 patients, establishing criteria for identifying ESS [2][5] - The criteria for ESS included an endotoxin activity assay (EAA) score of ≥ 0.6 combined with a Multiple Organ Dysfunction Score (MODS) > 9 or a Sequential Organ Failure Assessment (SOFA) > 11 [2] - The results align with the enrollment parameters of Spectral's recently completed Tigris trial, which tested PMX therapy in patients with high endotoxin levels and significant organ dysfunction [3][4][8]
Kazia Therapeutics Reports Complete Ex Vivo Disruption of Large Circulating Tumor Cell Clusters in Stage IV HER2-Positive Breast Cancer with Paxalisib Monotherapy
Prnewswire· 2025-09-11 12:00
Core Insights - Kazia Therapeutics Limited announced new findings from a collaborative research program indicating that paxalisib, an investigational PI3K–mTOR inhibitor, significantly reduces circulating tumor cells (CTCs) in Stage IV HER2-positive metastatic breast cancer patients [2][3] Company Overview - Kazia Therapeutics is an oncology-focused drug development company based in Sydney, Australia, with a lead program centered on paxalisib, which targets multiple forms of cancer [5] - The company has been developing paxalisib since it was licensed from Genentech in late 2016, and it has been involved in ten clinical trials for various cancers [5] Research Findings - In an ex vivo study, paxalisib monotherapy achieved a complete (100%) disruption of CTC clusters containing three or more cells, which are associated with metastasis and poor prognosis [2][6] - The results extend the understanding of paxalisib's potential beyond triple-negative breast cancer into HER2-positive disease, highlighting its ability to disrupt CTC clusters [3][6] - The findings complement ongoing Phase 1b trials in Stage IV triple-negative breast cancer, where significant reductions in CTCs and clusters have been observed [3] Future Directions - Detailed datasets regarding metastatic signatures and disrupted progenitor populations in Stage IV HER2-positive breast cancer have been submitted for presentation at an upcoming global oncology meeting in 2025 [4]
Why Relay Therapeutics Stock Rocketed Nearly 15% Higher This Week
The Motley Fool· 2025-09-05 22:42
Core Viewpoint - Relay Therapeutics is experiencing a positive market response, with a significant increase in share price attributed to a bullish analyst note and promising developments in its drug pipeline [1][2]. Group 1: Analyst Coverage and Price Target - Guggenheim Securities initiated coverage of Relay Therapeutics, designating it as a buy with a price target of $15 per share, which is nearly four times its recent closing price [2]. - The stock has been labeled as the firm's Best Idea, indicating strong confidence in its potential [2]. Group 2: Drug Development and Clinical Trials - The company is currently conducting a late-stage trial for its orally administered drug RLY-2608, which shows promise in treating breast cancer [4]. - The drug has a clean safety profile and has performed well in clinical studies, with additional potential for treating vascular malformations, an orphan disease affecting children [4]. Group 3: Financial Performance - Relay Therapeutics is trading below its cash position, which may attract stock bargain hunters [5]. - In the second quarter, the company reported earnings of $677,000, a significant improvement from $0 in the same period last year, and narrowed its per-share net loss by almost 41% to $0.41 [6].