Latest Regulatory Milestones News

E79 Gold Mines has reported outstanding high-grade copper and gold assay results from its Mountain Home Project in the Northern Territory, significantly expanding the known mineralised area and setting the stage for drilling in 2026.

ACDC Metals reports compelling mineralogy results from its Goschen Central project, highlighting elevated rare earth element grades that reinforce its economic potential. The announcement coincides with strategic momentum from the Australia-US Critical Minerals Framework, positioning the project as a key player in global supply chains.

Island Pharmaceuticals secures FDA confirmation that regulatory feedback on Galidesivir’s approval pathway will arrive on schedule, underscoring the drug’s strategic importance amid US government disruptions.

Woodside Energy has raised its 2025 production guidance following a 1% increase in quarterly output, while progressing key projects like Scarborough and Beaumont New Ammonia on schedule. The company also secured long-term LNG supply deals and received critical regulatory approvals.

Ballard Mining’s September quarter report highlights promising drilling results at its Mt Ida Gold Project and secures final approvals for a 2.0 Mtpa processing plant, underpinning its development ambitions.

Imagion Biosystems has made significant strides toward filing an IND application for its MagSense® HER2 breast cancer imaging agent, supported by positive FDA feedback and a recent $3.5 million capital raise to fund upcoming clinical trials.

BPH Global Ltd reports a steady increase in Indonesian seaweed sales alongside securing a crucial export licence, setting the stage for international market entry.

Southern Palladium has raised A$20 million through a strategic share placement to accelerate its Bengwenyama PGM project, positioning the company for key milestones including a Final Investment Decision in 2026.

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

Structural Monitoring Systems (ASX – SMN) reports a robust third consecutive profitable quarter, driven by soaring avionics sales and a landmark US defense contract via Canada’s CCC program. Revenue climbs 23% year-on-year, signaling strong momentum in its Special Mission communications business.

PainChek Limited has confirmed FDA De Novo classification for its PainChek Adult App, promptly disclosing the material regulatory milestone to the ASX and signalling a significant step towards US market entry.