Latest Regulatory News

Prescient Therapeutics has secured a key regulatory milestone with the EMA granting Orphan Drug Designation for PTX-100 to treat cutaneous T-cell lymphoma, while expanding its Phase 2a clinical trial across multiple continents.

Blue Energy Limited reports steady progress on its Sapphire gas project and awaits key government decisions on additional resource areas, positioning itself strongly in Queensland's evolving energy landscape.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.

Opthea Limited has streamlined its operations with a NASDAQ delisting and completed a strategic review, positioning itself to advance the OPT-302 treatment for LAM with a robust cash position.

Manuka Resources has released an updated 10-year Pre-Feasibility Study for its Cobar Basin projects, revealing a substantial uplift in project economics and a clear path to production by mid-2026.

Emerald Resources NL reported solid December quarter gold production from its Okvau Gold Mine and significant resource upgrades at its Dingo Range and Memot projects, underpinning its growth trajectory.

MRG Metals has expanded its rare earth portfolio through the acquisition of the high-grade Garies Rare Earth Project in South Africa, while also progressing key projects in Mozambique, signalling a diversified growth strategy in critical minerals.

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.