Latest Biomarkers News

TrivarX has solidified its regulatory strategy for the pivotal MEB-001 trial with the FDA and unveiled a new algorithm that expands its mental health screening reach beyond sleep clinics.

Advanced Health Intelligence Ltd has locked in a USD$4 million convertible note facility with UAE-based KOR Investments LLC, aiming to raise up to AUD$10 million to fuel its MENA expansion and reduce debt.

Alterity Therapeutics has reported positive Phase 2 results for ATH434, showing significant slowing of Multiple System Atrophy progression and a favorable safety profile. The trial demonstrated clinical benefits alongside reductions in brain iron accumulation, a key disease driver.

Alterity Therapeutics has announced encouraging Phase 2 trial results for ATH434, showing significant slowing of disease progression in multiple system atrophy (MSA) patients and a strong safety profile. These findings mark a potential breakthrough in treating a disease with no approved therapies.

Actinogen Medical accelerates recruitment in its pivotal XanaMIA Alzheimer's trial while securing a strong cash position of $22.9 million, underpinning its late-stage development and commercial readiness.

Pacific Edge announces a two-month delay in the Medicare Local Coverage Determination for its genetic oncology tests, extending the effective date to April 24, 2025. This extension follows the company’s active engagement with US regulatory bodies.

Alterity Therapeutics is poised to release topline data from its pivotal ATH434-201 Phase 2 trial in early-stage Multiple System Atrophy by February 2025, while managing a cash balance of A$4.54 million amid ongoing research expenses.

Cardiex Limited has commenced U.S. deliveries of its CONNEQT Pulse arterial health monitor alongside the launch of its companion CONNEQT App, marking a pivotal expansion into the American digital health market.

Archer Materials has been granted a pivotal US patent for its Biochip technology, safeguarding its intellectual property and positioning the company for strategic entry into the lucrative US medical diagnostics market.

Pacific Edge faces a significant Medicare reimbursement setback as Novitas finalizes a non-coverage decision for its Cxbladder tests, prompting the company to activate legal challenges and operational restructuring.