Latest Clinical Evidence News

Cleo Diagnostics (ASX:COV) posted a 48% jump in annual loss to $5.9 million amid key progress in its ovarian cancer diagnostic test, including completion of a pivotal US trial and preparations for FDA 510(k) submission.

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.

Artrya Limited marked its first full year of US commercial operations with a $25.18 million loss, driven by regulatory clearances, customer contracts, and an $80 million capital raise.

Entropy Neurodynamics has partnered with BioCina to establish GMP manufacturing for its intravenous psilocin formulation TRP-8803, a critical step toward late-stage clinical trials and commercialisation.

Imricor Medical Systems has ignited its US commercial operations with rapid adoption by top pediatric hospitals, buoyed by FDA pediatric clearances and clinical trial progress.

ReNerve has secured marketing approval for its NervAlign® Nerve Cuff in the Philippines, tapping into a major Southeast Asian market with significant nerve injury demand.

Clarity Pharmaceuticals has presented compelling clinical evidence that its investigational 64Cu-SAR-bisPSMA diagnostic and 67Cu-SAR-bisPSMA therapeutic candidates outperform current standards in prostate cancer care, positioning the company for regulatory and commercial milestones.

AdAlta’s lead CAR-T therapy EW-001 has achieved a rare clinical milestone with one mesothelioma patient remaining cancer-free two years after treatment, and a second reaching one-year survival, underscoring the therapy’s potential durability in a notoriously difficult cancer.

4DMedical has secured a pivotal three-year contract with SimonMed Imaging to deploy its CT:VQ™ lung imaging technology across over 170 US outpatient centres, while FY26 revenue rose 23% to $7.2 million on record scan volumes and global expansion.

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.

OncoSil Medical reported a 53% increase in unit sales and advanced key regulatory approvals, including FDA final review and TGA listing, positioning it for growth in pancreatic cancer treatment.

PainChek lifted implemented ARR by 5.9% to $4.46 million and secured its first US commercial contracts under a major Sabra REIT agreement, boosting customer receipts 27% in the June quarter.