Latest Biomarkers News

Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.

Proteomics International has unveiled new clinical data confirming its PromarkerEso blood test can accurately detect early stages of esophageal adenocarcinoma, potentially transforming screening for a cancer with poor prognosis.

Cardiex Limited reported a 10% revenue increase in FY25, driven by new product launches and significant cost reductions, positioning the company for growth in FY26 with strong backing from C2 Ventures.

Resonance Health Limited reported a 29% revenue increase to $11.07 million for FY25 but posted a net loss of $1.73 million, reflecting strategic investments and expansion in clinical trial services.

Alterity Therapeutics reported a reduced net loss of A$12.15 million for FY2025, buoyed by positive Phase 2 clinical trial results for its lead drug ATH434 in Multiple System Atrophy and a successful A$40 million capital raising.

Tryptamine Therapeutics reported a $5.33 million loss for FY25 while progressing key clinical trials of its psychedelic therapies and strengthening its leadership team. The company secured $6 million in funding and launched a world-first trial targeting Binge Eating Disorder.

PYC Therapeutics has reported promising safety data from the initial phase of its clinical trial for PYC-003, an RNA therapy targeting the root cause of Polycystic Kidney Disease. The findings, presented at the ANZSN conference, highlight the drug’s tolerability in healthy volunteers, paving the way for further clinical development.

Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.

INOVIQ Limited reported a $6.9 million net loss for FY25 while making significant strides in its exosome-based cancer diagnostics and therapeutics pipeline, including a breakthrough ovarian cancer screening test and promising CAR-exosome therapy results.

Tryptamine Therapeutics has secured an exclusive agreement with leading neuroscientists to develop a novel EEG-based brain entropy biomarker aimed at enhancing precision psychiatry for its psychedelic drug TRP-8803.

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.