Latest Regulatory Milestones News

Javelin Minerals has lodged its Mining Proposal for the Eureka Gold Project, setting the stage for mining to commence in mid-2026 and first cashflow by Q3. Fully funded and partnered with MEGA Resources, the project is on track to unlock value in Western Australia’s prolific goldfields.

4DMedical has gained Canadian regulatory approval for its innovative CT – VQ™ ventilation-perfusion imaging technology, enabling immediate commercial rollout through Philips and expanding its North American footprint.

Western Yilgarn NL has secured critical access rights for its Cardea 2 Bauxite Project, enabling immediate fieldwork, while simultaneously initiating ground exploration at the Ida Holmes Junction Project targeting key critical minerals.

Diatreme Resources has submitted the Draft Environmental Impact Statement for its Northern Silica Project, marking a significant step toward regulatory approval and highlighting its potential to boost regional economies and support global solar energy growth.

Prescient Therapeutics has secured European authorization to initiate a Phase 2a clinical trial of its novel cancer drug PTX-100 for relapsed/refractory Cutaneous T-cell Lymphoma, enabling trial site activation in Italy.

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.

Rhythm Biosciences has begun commercialising ColoSTAT®, its blood-based colorectal cancer diagnostic test, following an updated ISO15189, 2022 accreditation. The test offers a new option for symptomatic patients where stool-based screening is unsuitable.

Jindalee Lithium has secured US Bureau of Land Management approval for its McDermitt Lithium Project’s Exploration Plan, paving the way for expanded drilling and advancing the project towards a feasibility study.

Neurizon Therapeutics has secured FDA clearance for its lead drug candidate NUZ-001 to enter the HEALEY ALS Platform Trial, marking a key regulatory milestone and setting the stage for patient enrollment in early 2026.