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- Precipio (PRPO) combines clinical laboratory services with proprietary diagnostic product development, with pathology services focused primarily on hematologic cancers. - Biodesix (BDSX) provides blood-based diagnostic testing for lung disease, including tests that assess cancer risk in lung nodules and guide post-diagnosis treatment. - Biodesix has outperformed Precipio over the past three months (up 64.5% vs. 26.4%) and over the past year (up 150.9% vs. 112%). - Both stocks trade below the Zacks Medical sector average EV/S of 2.92X, with PRPO at 1.90X and BDSX at 2.89X.
- Verici Dx has attained Olink Certified Service Provider status, enabling Olink-based proteomics assay services from its CAP-certified/CLIA-accredited laboratory. - The certification allows Verici Dx to support biomarker discovery, algorithm development, validation, and clinical trial applications for both clients and its internal pipeline. - Verici Dx has already applied its Olink-certified capabilities in a collaboration with a major pharmaceutical company evaluating samples from a GLP-1 clinical trial. - The company differentiates itself by offering integrated bioinformatics expertise and multi-omics capabilities within a CAP/CLIA/ISO-compliant quality framework.
- Sangamo Therapeutics, a three-decade-old gene editing pioneer, filed for Chapter 11 bankruptcy with $115 million in debt and just $5.5 million in cash remaining. - Eli Lilly has offered $50 million for Sangamo's core gene editing platforms and an experimental prion disease treatment, while Astellas bid up to $50 million for a Fabry disease gene therapy nearing regulatory approval. - The company's partnership model collapsed after Novartis, Biogen, and Pfizer terminated major collaborations, causing revenues to plummet from $176.2 million in 2023 to $39.6 million in 2025. - A court-supervised auction is scheduled for next month, with 77 employees retained specifically for the asset purchases by Lilly and Astellas.
- Bio-Techne Corporation operates as a high-quality life sciences supplier with 65–70% gross margins and recurring consumables revenue, serving pharmaceutical R&D, biotech, and academic labs globally. - The company benefits from deep customer lock-in driven by experimental reproducibility requirements, where validated reagents are reordered under identical catalog numbers for years. - Near-term performance faces cyclical pressure from reductions in U.S. academic funding, though the larger pharma R&D customer base remains the dominant and more resilient revenue driver. - Analyst consensus maintains Buy ratings with a median price target of $76, implying approximately 28% upside from the $52.65 share price as of June 8th.
- Kincell Bio, a leading cell therapy CDMO, has promoted Lawrence "Larry" Pitcher from COO to Chief Executive Officer effective immediately. - Pitcher succeeds Mark R. Bamforth OBE, who transitions to Executive Chair after guiding the company through a successful growth phase in 2025. - The leadership change comes as Kincell Bio expands its manufacturing capabilities to support clients' cell therapy programs progressing into pivotal studies and commercial launch. - Pitcher brings extensive experience from leadership roles at Catalent, Thermo Fisher, and other major biomanufacturing companies across cell and gene therapy operations.
- The U.S. cell and gene therapy CDMO market is projected to grow from $1.94 billion in 2025 to $10.34 billion by 2033, representing a robust 23.26% compound annual growth rate. - Recent FDA approvals of breakthrough therapies including Casgevy for sickle cell disease and Elevidys for Duchenne muscular dystrophy are driving increased demand for specialized manufacturing partnerships. - Over 2,000 ongoing clinical trials in cell and gene therapies are creating unprecedented demand for viral vectors, plasmids, and clinical-grade cell processing capabilities. - Leading CDMO players including Lonza, Catalent, WuXi Advanced Therapies, and Thermo Fisher are investing heavily in expanding manufacturing capacity to meet surging outsourcing demand.
- Ludwig Enterprises published ASCO abstract detailing a novel non-invasive breast cancer screening test that analyzes mRNA from buccal cheek swab samples collected across 40 U.S. clinical centers. - The study identified six-biomarker combinations using machine learning algorithms that achieved excellent performance metrics with F-scores ≥0.85 for breast cancer detection. - Two top-performing biomarker systems demonstrated high precision (0.888-0.892) and recall (0.902-0.913) values, suggesting potential clinical utility for early breast cancer detection. - The research focuses on mRNA-based cytokine biomarkers associated with inflammatory pathways and cancer development, offering complementary insights to traditional DNA genetic testing.
- Lyndra Therapeutics and Thermo Fisher Scientific have entered a strategic collaboration to advance Lyndra's long-acting oral therapies. - Thermo Fisher will provide global clinical research and commercial manufacturing services for Lyndra, including its lead product, oral weekly risperidone (LYN-005). - LYN-005 demonstrated efficacy compared to daily Risperdal in a Phase III pivotal study, with a safety study planned for early 2025. - The collaboration leverages Thermo Fisher’s Accelerator Drug Development services and aims to bring groundbreaking, long-acting oral therapies to patients.
- FDA's finalized regulations on laboratory-developed tests (LDTs) require 510(k) clearance or premarket approval, with the first phase beginning in May 2024. - Major laboratory organizations, including ACLA and CAP, have mounted legal challenges against the FDA's rule, arguing it could impede innovation and access to essential diagnostic services. - A new stakeholder coalition is working on alternative legislation to replace the failed VALID Act, aiming to establish a more balanced regulatory framework for LDTs.
• Early-phase oncology trials are evolving to incorporate efficacy endpoints alongside safety, driven by novel targeted and immunotherapeutic agents. • Refining trial designs and patient selection is crucial to improve efficiency and maximize therapeutic intent in immunotherapeutic drug development. • Management of treatment-related adverse events from next-generation immunotherapies requires adaptive trial designs and specialized expertise. • Research aims to identify prognostic markers and implement pharmacodynamic markers to better assess novel immunotherapeutic agents.
