Latest Regulatory News

Australian Strategic Materials secures A$50.8 million via share placement to fund Korean plant expansion and advance US metals project, while navigating complex supply chain and funding risks.

AdAlta Limited has raised up to A$1.1 million through a private placement, boosting its war chest to advance innovative cellular immunotherapy projects targeting solid cancers.

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.

Red Sky Energy has mobilised drilling equipment to the KN2 well site at Killanoola, with regulatory approvals advancing smoothly and drilling expected to begin soon.

Wide Open Agriculture has developed a novel lupin protein milk formulation that overcomes longstanding technological hurdles, lodging a patent to protect its innovation and gearing up for global commercialisation.

Actinogen Medical has fast-tracked recruitment in its XanaMIA Alzheimer’s trial, closing pTau biomarker screening early and increasing participant numbers, aiming for final results by mid Q4 2026.

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

Race Oncology showcased compelling preclinical data at ESMO 2025 revealing that their drug RC220, combined with doxorubicin, not only shields the heart from toxicity but also boosts anticancer effects, supporting ongoing clinical trials.

Imricor Medical Systems has completed the world’s first Pulsed Field Ablation procedure under real-time MRI guidance, marking a breakthrough in cardiac ablation technology. This pre-clinical success validates their Vision-MR platform’s adaptability and sets the stage for safer, radiation-free heart treatments.

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.

Prodigy Gold has reported a milestone with over one million ounces of gold in its resource inventory, alongside significant exploration progress and a successful $7.13 million capital raise to fund ongoing development.

Winsome Resources has completed its share entitlement in Power Metals Corp, now holding a 16.1% stake and retaining key offtake rights for lithium and other critical minerals from Power Metals’ Ontario project.