Latest Regulatory News

Imagion Biosystems has made significant progress towards filing an Investigational New Drug application for its MagSense® HER2 breast cancer imaging agent, receiving encouraging feedback from the FDA and preparing for a Phase 2 clinical trial.

Bastion Mining has taken control of over 90% of Xanadu Mines shares through a takeover bid, moving swiftly to compulsory acquisition and setting the stage for the Kharmagtai project’s next phase.

Paradigm Biopharmaceuticals has advanced its global Phase 3 trial for knee osteoarthritis pain with active patient recruitment in Australia and the US, backed by a $41.2 million convertible note facility. The company also expanded its osteoarthritis portfolio through the acquisition of Proteobioactives and the Pentacoxib™ oral therapy.

Global Uranium and Enrichment Limited’s investee Ubaryon has sealed a binding agreement with uranium giant Urenco, unlocking a A$5 million investment and technical collaboration to accelerate a novel uranium enrichment technology.

Cavalier Resources progresses its Crawford Gold Project with key milestones including an $11 million stream finance negotiation with Raptor Capital and the appointment of Colin Bald as General Manager of Operations.

Black Dragon Gold has entered a critical public consultation phase for its Salave Gold Project’s land use change, marking a key step in its strategic project application amid local government opposition and strong community backing.

SomnoMed reports a robust Q4 FY25 with 25% revenue growth and a milestone of treating over 1 million patients, while gearing up for significant capacity expansion and clinical advancements.

Avecho Biotechnology reports strong progress in its Phase III clinical trial for a CBD-based insomnia treatment, with recruitment accelerating across multiple Australian sites and interim results expected early next year.

Patagonia Lithium Ltd has announced a fully underwritten entitlement offer to raise approximately $2.68 million, aimed at advancing its drilling program in Argentina and updating its mineral resource estimates. The offer, supported by major shareholders, reflects confidence in the company’s Formentera Lithium Brine Project.

Tigers Realm Coal’s planned sale of its Russian subsidiaries faces significant delays and a pricing impasse, with regulatory hurdles and sanctions complicating the exit process and triggering an ASX trading suspension.

Elementos Limited has delivered a robust Definitive Feasibility Study for its Oropesa Tin Project in Spain, secured a $5 million strategic investment from Metals X, and progressed exploration at its Cleveland Tin Project in Tasmania.

Urbanise.com Limited reported a 4.2% revenue increase for FY2025, driven by a landmark partnership and equity investment from National Australia Bank. The company achieved positive operating cash flow for the fourth consecutive quarter, setting the stage for its next growth phase.