Latest Biomarkers News

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.

Pacific Edge reported a steep 47% revenue drop in FY26 following Medicare coverage loss but secured a draft Medicare policy covering its Cxbladder tests and raised NZ$25.4 million to fuel growth and commercial execution.

Cleo Diagnostics has laid out a clear U.S. reimbursement pathway for its ovarian cancer test, leveraging an existing CPT code to enable early market entry and data collection ahead of FDA clearance.

Alterity Therapeutics has showcased compelling Phase 2 data for ATH434 in Multiple System Atrophy, paving the way for a Phase 3 trial with FDA engagement targeted for mid-2026.

Amplia Therapeutics has launched a Phase 2b trial testing a new daily dosing regimen of narmafotinib combined with chemotherapy in advanced pancreatic cancer, aiming to accelerate progress towards a pivotal Phase 3 study.

Pacific Edge edges closer to a Medicare breakthrough with a draft Local Coverage Determination proposing coverage for its Cxbladder Triage and Triage Plus tests, potentially unlocking reimbursement for over 66 million US patients.

Pacific Edge launches a NZ$6 million retail share offer at NZ$0.17 per share following a NZ$25.4 million institutional placement, aiming to strengthen its balance sheet and support Medicare reimbursement efforts for its bladder cancer diagnostics.

Neurizon Therapeutics has gained ethics approval to start a Phase 1 trial of its NUZ-001 oral liquid formulation, aiming to ease treatment for ALS patients with swallowing difficulties.

Pacific Edge is raising NZ$24 million to shore up its finances and support a crucial Medicare re-coverage bid following a steep revenue drop after losing Medicare reimbursement for its bladder cancer test. The company eyes a draft Medicare policy by September 2026 as a potential turning point.

Amplia Therapeutics and ANZGOG have initiated a clinical trial to test narmafotinib combined with chemotherapy in ovarian cancer patients unresponsive to platinum-based treatment, aiming to improve surgical outcomes and explore biomarker insights.

PYC Therapeutics has dosed the first patient in its Phase 1b trial of PYC-003, targeting Polycystic Kidney Disease, aiming to establish safety and efficacy markers ahead of registrational studies.