Latest Regulatory News

Paradigm Biopharmaceuticals reports solid progress in its Phase 3 knee osteoarthritis trial, expanding internationally and publishing key Phase 2 biomarker data. The company maintains a robust cash position to support ongoing clinical milestones.

Evion Group gains momentum as the US-Africa Strategic Infrastructure and Investment Working Group fosters trade, Madagascar accelerates mining permits, and Indian graphite operations deliver strong sales.

Noxopharm has successfully completed dosing in its HERACLES clinical trial for SOF-SKN™, demonstrating strong safety and tolerability. The company also secured a new overseas partnership and its first US patent for the Sofra platform.

Beetaloo Energy has secured key regulatory approvals and approved the Final Investment Decision for its Carpentaria Pilot Project, setting the stage for first gas sales from EP187 in late 2026.

PainChek has achieved FDA regulatory clearance enabling its device to qualify for US Remote Therapeutic Monitoring reimbursement, positioning the company for significant growth in the expanding US healthcare market. The company also reports strong global licence growth and a solid pipeline across multiple regions.

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

Kingsrose Mining’s December quarter report reveals steady progress in its Finnmark exploration alliance and a significant permitting hurdle at its Penikat project in Finland. The company maintains a solid cash position as it plans for 2026 drilling campaigns.

Neurizon Therapeutics has cleared a major regulatory hurdle with the FDA lifting the clinical hold on its lead drug NUZ-001 and secured a comprehensive $33 million funding package to advance its pivotal ALS trial.

Entropy Neurodynamics has successfully enrolled and dosed the first patient in its pioneering clinical trial of TRP-8803, an intravenous psilocin formulation targeting Binge Eating Disorder, while securing $6.1 million in new funding to accelerate development.

Neurotech International has secured a Rare Pediatric Disease Designation from the FDA for its lead drug NTI164 targeting Rett syndrome, alongside publishing promising clinical data and raising $8.7 million to fuel further development.

Besra Gold Inc has updated its Bau Gold Project resource estimate and is intensifying efforts to secure critical mining lease renewals, while restructuring its operations to sharpen capital discipline and technical oversight.

The Calmer Co has posted a record $2.01 million in sales for Q2 FY26, propelled by a 9% increase in US revenue which now accounts for over half of the group’s total income. Strong retail and wholesale growth underpin the company’s expanding footprint in the natural relaxation market.