Latest Biomarkers News

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.

4DMedical has made significant strides in commercial adoption of its CT:VQ™ lung imaging technology, securing top US hospital contracts, regulatory approvals in Europe and the UK, and a major pharmaceutical partnership, all backed by strong capital raises and inclusion in the S&P/ASX 200.

Percheron Therapeutics has secured $2.2 million through an entitlement offer to fund the next stage of its HMBD-002 oncology program, with manufacturing underway and key data presentations lined up at major cancer conferences.