Latest Regulatory Milestones News

Neurotech International has secured $4.5 million through a share placement to fund its pivotal Phase III clinical trial of NTI164 for Autism Spectrum Disorder, aiming to reach topline data readout.

Lumos Diagnostics has landed a US$767,800 purchase order for its FebriDx rapid test from PHASE Scientific, marking a key step in commercialising its FDA-approved product ahead of the US flu season.

Control Bionics has achieved FDA registration for its NeuroStrip surface EMG platform, cementing its medical device status in the US and bolstering its appeal in clinical and research markets.

Elementos Limited has cleared all conditions to acquire up to 50% of Iberian Smelting, advancing its integrated European tin mine-to-metal strategy by linking its Oropesa project with downstream smelting capacity in Spain.

Lake Resources has commenced the last regulatory hurdle for its Kachi Lithium Brine Project in Argentina, with a month-long public consultation underway ahead of an expected environmental approval in September.

Neurotech International has secured FDA clearance for its NTI164 Investigational New Drug application and obtained Notices of Allowance for two US patents, advancing its Phase 3 autism spectrum disorder program.

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.

Theta Gold Mines has locked in a US$90 million senior secured bond and raised US$18.6 million in equity, pushing its TGME Gold Project construction steadily towards first gold in early 2027.

Tissue Repair advances its US Phase III chronic wound trial with 100 patients randomised and targets October FDA 510(k) submission. The company reports a robust cash position bolstered by R&D refunds and has cut manufacturing scale-up costs.

Latitude 66 secures key exploration permits for its high-grade KSB gold-cobalt project in Finland and reports strong assay results from Laverton drilling in Western Australia, setting the stage for resource growth and development studies.

Coda Minerals has delivered critical pre-feasibility study data and secured funding to push its Elizabeth Creek copper-silver project towards development milestones, including environmental approvals and expanded drilling.

Orange Minerals confirmed significant deep volcanic massive sulphide mineralisation at Lennon’s Find in WA, secured ministerial consent for Ghana licence transfers, and completed a $1.675 million placement to fund exploration.