Latest Regulatory Milestones News

GoldArc Resources has cleared the last regulatory hurdle for its Mt Stirling gold project, enabling development to proceed under a 50/50 profit-share partnership with BML Ventures.

Imricor Medical Systems has ignited its US commercial operations with rapid adoption by top pediatric hospitals, buoyed by FDA pediatric clearances and clinical trial progress.

Flynn Gold has inked a non-binding Ore Purchase Agreement with Kaiser Reef's Henty Gold Mine, opening a potential low-capital route to production for its Golden Ridge project in Tasmania.

Neuren Pharmaceuticals saw a record Q2 with DAYBUE net sales hitting US$125 million, driven by strong uptake of the new STIX formulation. The company upgraded its 2026 royalty guidance following Acadia Pharmaceuticals’ sales boost and awaits key regulatory milestones in Europe and Japan.

AdAlta’s lead CAR-T therapy EW-001 has achieved a rare clinical milestone with one mesothelioma patient remaining cancer-free two years after treatment, and a second reaching one-year survival, underscoring the therapy’s potential durability in a notoriously difficult cancer.

CurveBeam AI has launched a Share Purchase Plan offering eligible shareholders a 10% discount on new shares, aiming to raise up to $2 million alongside a pending $5 million placement.

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.