Latest Biomarkers News

Neurizon Therapeutics reports encouraging topline results from its Phase 1 Open-Label Extension study of NUZ-001, demonstrating long-term safety and a significant survival advantage in ALS patients. These findings pave the way for the pivotal HEALEY ALS Platform Trial planned for late 2025.

Cleo Diagnostics has launched a health economic study in partnership with EntityRisk and Norstella to support the U.S. market entry of its Ovarian Cancer Pre-Surgical Test, aiming to refine reimbursement strategies and accelerate commercialisation.

Anatara Lifesciences reported a 35% rise in net loss to $1.95 million for FY25, following pivotal Phase II trial results for its GaRP product that missed the primary efficacy endpoint but showed promising secondary benefits. The company is advancing commercialisation efforts and launching a new anti-obesity project amid tightened cash reserves.

Invex Therapeutics reports a significantly reduced net loss for FY25, driven by lower R&D costs after closing its Phase III trial, while advancing promising pre-clinical Alzheimer’s research through a collaboration with Tessara Therapeutics.

Rhythm Biosciences has advanced its ColoSTAT® diagnostic kits to final production validation, demonstrating consistent detection of colorectal cancer across all stages in a pivotal study. The company is gearing up for regulatory submission and commercial launch later this year.

Chimeric Therapeutics has progressed its CHM CDH17 CAR-T cell therapy to dose level 2 in its Phase 1/2 trial, showing promising early anti-tumor activity and a strong safety profile in gastrointestinal and neuroendocrine cancers.

4DMedical reports a 56% revenue surge in FY25 alongside a strategic $10 million investment from Pro Medicus, advancing its CT, VQ™ lung imaging technology towards FDA clearance.

INOVIQ Limited reports breakthrough results for its ovarian cancer screening test achieving perfect early-stage detection, alongside promising advances in its CAR-exosome cancer therapy program.

Alterity Therapeutics has secured U.S. FDA Fast Track designation for its drug ATH434 targeting Multiple System Atrophy, supported by promising Phase 2 clinical trial data showing slowed disease progression and a solid safety profile.

Actinogen Medical has reached a key milestone in its XanaMIA phase 2b/3 Alzheimer’s trial with over 100 participants enrolled, setting the stage for an interim analysis in January 2026. The company also secured a $13.8 million non-dilutive R&D funding facility to support ongoing development.

BCAL Diagnostics has reported strong early commercial uptake of its BREASTEST plus non-invasive breast cancer diagnostic test, alongside a new partnership with Cancer Care Associates to expand market reach.

Paradigm Biopharmaceuticals has advanced its global Phase 3 trial for knee osteoarthritis pain with active patient recruitment in Australia and the US, backed by a $41.2 million convertible note facility. The company also expanded its osteoarthritis portfolio through the acquisition of Proteobioactives and the Pentacoxib™ oral therapy.