Latest Biomarkers News

Proteomics International has won a key US patent for its PromarkerEndo blood test, bolstering its commercial foothold in the world’s largest healthcare market. The patented technology offers a non-invasive, accurate diagnosis of endometriosis, a condition that currently takes years to detect.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

CONNEQT Health Limited is offering eligible shareholders a share purchase plan to raise up to $0.5 million at a 24.3% discount, aiming to fund its next growth phase in vascular health technology.

Lumos Diagnostics has received a A$709,837 cash refund from the Australian Government’s R&D Tax Incentive, bolstering its investment in proprietary point-of-care diagnostic technologies.

Pacific Edge reported a $35.8 million loss in FY26 amid a 47% revenue drop following Medicare coverage loss, but a draft Medicare policy and $36.1 million capital raise set the stage for recovery.

CONNEQT Health has lodged an FDA Pre-Submission for SphygmoCor Cloud, aiming to shift its arterial health analytics from hardware to a scalable software platform with broad commercial potential.

Actinogen Medical’s pivotal XanaMIA Alzheimer’s trial has passed a third independent safety review, endorsing continuation without changes. Final topline efficacy data is expected in November 2026.

Resonance Health is progressing its MRI Liver Fibrosis device through late-stage clinical validation, targeting FDA biomarker qualification, while maintaining a profitable SaaMD platform and forecasting $16 million revenue for FY26.

Alterity Therapeutics has clinched FDA agreement on the pivotal Phase 3 trial design for ATH434, targeting Multiple System Atrophy, with the trial set to begin by the end of 2026.

Chimeric Therapeutics reports encouraging Phase 1/2 data for its CHM CDH17 CAR-T therapy in advanced gastrointestinal cancers, with 82% of evaluable patients achieving stable disease and durable responses lasting over a year.

Actinogen Medical has obtained positive scientific advice from the European Medicines Agency that aligns with prior FDA guidance, clarifying regulatory requirements for its Alzheimer’s drug Xanamem and paving the way for a streamlined approval process in major markets.

Neurizon Therapeutics has boosted the participant count in its HEALEY ALS Platform Trial Regimen I from 160 to 240, capitalising on faster enrolment and philanthropic support to maintain costs and accelerate topline results to early Q3 2027.