Latest Biomarkers News

Racura Oncology has launched patient enrolment at its first Korean site for the CPACS Phase 1 trial, aiming to accelerate recruitment and validate RC220’s safety and efficacy in a key oncology market.

Invex Therapeutics posted a $1.35 million net loss for FY2026, driven by expanded R&D efforts and a deepening collaboration with Tessara Therapeutics targeting neurological diseases including Alzheimer’s. The company renewed its orphan drug status in Europe and restructured its board during the year.

PYC Therapeutics strengthened its financial footing with a $600 million capital raise and made notable clinical progress across four RNA therapeutic programs targeting genetic diseases.

Entropy Neurodynamics (ASX:ENP) reported a 30% rise in income and a narrower loss for FY26, driven by clinical progress in its IV-infused psilocin therapy TRP-8803, including promising Phase 2 results in Binge Eating Disorder and a new multi-indication basket study.

Pacific Edge’s draft Medicare Local Coverage Determination for its Cxbladder bladder cancer tests marks a pivotal step toward unlocking a $10.2 billion global market. Despite FY26 setbacks, the company is poised for growth with improved reimbursement prospects and strategic cost management.

Proteomics International has achieved a key patent acceptance in Australia for its PromarkerEndo blood test, reinforcing its intellectual property portfolio and commercialisation strategy in a major healthcare market.

Clarity Pharmaceuticals reveals encouraging early results from the SECuRE trial, with substantial PSA reductions and multiple complete responses at the 8 GBq 67Cu-SAR-bisPSMA dose level in advanced prostate cancer patients.

Alterity Therapeutics has cleared a major regulatory hurdle with the FDA endorsing a single pivotal Phase 3 trial for its ATH434 drug in Multiple System Atrophy, setting the stage for trial initiation by the end of 2026.

Cleo Diagnostics has entered the critical Analytical Validation phase for its ovarian cancer blood test, progressing toward an FDA 510(k) submission targeted for the first half of 2027. The company also secured a U.S. reimbursement pathway to support early market entry post-clearance, backed by a cash balance of A$6.2 million.

Amplia Therapeutics reported encouraging mature data from its ACCENT trial, initiated a Phase 2b pancreatic cancer study, launched an ovarian cancer trial, and refreshed its board leadership while maintaining a solid cash balance of A$24 million.

Proteomics International Laboratories has streamlined operations, secured a key US patent for its endometriosis test, and inked a three-year exclusive distribution deal with Healius for its Promarker diagnostics in Australia.

Nyrada has dosed the first patient in its Phase IIa trial of Xolatryp targeting heart attack recovery, while strengthening its cash reserves and receiving a US patent allowance for its lead drug.