Latest Regulatory News

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

Island Pharmaceuticals has submitted critical responses to the FDA, advancing the development of its antiviral Galidesivir under the Animal Rule pathway. The company awaits FDA feedback expected by early January 2026, setting the stage for upcoming Marburg virus studies.

AdAlta Limited has received a $0.78 million Research and Development Tax Incentive refund for FY2025, using part of it to repay a Radium Capital loan and strengthening its cash position as it nears a key licensing milestone.

Aguia Resources is advancing steadily towards mining commencement at its Três Estradas phosphate project in Brazil, with key infrastructure completed and sales agreements signed for its PAMPAFOS™ fertilizer product.

Cavalier Resources reports significant high-grade gold intercepts from recent drilling at its Crawford Gold Project, reinforcing the potential for expanded mining operations. A revised Pre-Feasibility Study highlights robust economics underpinning the project’s next development phase.

Bendigo and Adelaide Bank has agreed to acquire RACQ Bank’s retail lending assets and deposits, expanding its customer base and enhancing geographic diversity. The deal is expected to be accretive to earnings and align with the bank’s 2030 return targets.

Nuix Limited has announced its acquisition of Paris-based graph intelligence firm Linkurious for up to €20 million, aiming to enhance its AI-driven data analytics capabilities and expand its global footprint.

Critical Resources Limited has completed the acquisition of the Cap Burn Gold Project in New Zealand, securing key permits and land access to launch its inaugural drilling program in a highly prospective gold region.

Argenica Therapeutics has demonstrated that its lead drug candidate ARG-007 does not interfere with the clot-busting agent tenecteplase, fulfilling a critical FDA requirement and advancing its stroke therapy development.

True North Copper has launched a right-sized Pre-Feasibility Study for its Cloncurry Copper Project following strong 2025 drilling results, aiming to refine resource estimates and optimise development plans ahead of a potential investment decision in 2026.

Pacific Edge appoints Simon Flood as chairman designate, aiming to leverage his global investment expertise to navigate Medicare reimbursement challenges for its bladder cancer diagnostic tests in the US.

Trading in Restaurant Brands New Zealand Limited shares has been suspended following compulsory acquisition notices issued by Finaccess Restauración, S.L., signaling a pivotal ownership change.