Latest Regulatory Milestones News

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.

Rua Gold’s Auld Creek Project has qualified for New Zealand’s new Fast-Track Approvals Act 2024, promising a faster permitting timeline and reduced regulatory risk as the company advances toward mine development.

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.

Island Pharmaceuticals has marked a major step forward in its antiviral program with the start of GMP manufacturing for Galidesivir, expanded USAMRIID collaboration, and FDA orphan drug designation. Regulatory approvals for compassionate use in Uganda’s Ebola outbreak and a new dose optimisation study with Texas Biomed further de-risk the pathway to approval.

EBR Systems advanced its wireless cardiac pacing rollout in Q2 2026, completing 46 implants and signing 17 new purchasing contracts while shifting focus to deeper utilisation within existing accounts.

Connected Minerals has secured shareholder and regulatory approvals to acquire Frontier Group, gaining an 80% stake in Angola’s Bailundo Carbonatite Project with expanded mineral rights including niobium and rare earths. Completion is imminent as exploration activities ramp up.

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.