Latest Biomarkers News

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.

BlinkLab has completed onboarding all clinical sites for its pivotal FDA autism trial, enrolled the first participant, and launched a nationwide autism screening program in Morocco. A recent A$17.7 million capital raise will fund further trials and expansion into ADHD diagnostics.

Cleo Diagnostics (ASX:COV) has hit a major milestone by completing sample collection for its pivotal U.S. ovarian cancer trial, while progressing manufacturing and analytical validation steps toward FDA 510(k) submission.

CONNEQT Health’s Pulse device sales surged to a $7 million annualised run-rate despite a temporary supply hiccup, while the company manages a tight cash runway supported by new R&D loans and related-party funding.

Entropy Neurodynamics has reported encouraging early clinical outcomes from its pioneering intravenous psilocin therapy for Binge Eating Disorder, alongside a patent grant that strengthens its intellectual property moat.

Cleo Diagnostics has kicked off a staged manufacturing program with Bio-Techne to produce ovarian cancer test kits, moving from clinical sample collection to analytical validation and FDA submission preparation.

Paradigm Biopharmaceuticals has upsized a $14 million placement and launched a $2 million SPP, boosting its cash runway to around $45 million. This capital injection supports the ongoing Phase 3 trial for knee osteoarthritis, with interim results expected in Q3 2026.