Latest Regulatory Milestones News

High Peak Royalties finalises the sale of its geothermal subsidiary Torrens Energy to Northstar Energy, gaining significant equity and royalty interests while advancing South Australia's clean energy ambitions.

NEXTDC has received State Significant Development approval for its S4 Sydney Data Centre at Horsley Park, clearing a major regulatory hurdle for its expansion plans in New South Wales.

Caravel Minerals reports substantial progress on its Definitive Feasibility Study for the Caravel Copper Project, advancing engineering, environmental approvals, and strategic partnerships toward development.

Neurizon Therapeutics has locked in a $44 million funding package to fully support its lead drug NUZ-001 in the HEALEY ALS Platform Trial, marking a critical step toward potential regulatory approval and broader neurodegenerative applications.

BCI Minerals has secured crucial environmental approvals to proceed with its optimized dredging strategy at the Mardie Salt Operation, setting the stage for first salt shipments by late 2026.

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.

Neuren Pharmaceuticals has secured Health Canada approval to expand its pivotal Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome into Canadian sites, complementing ongoing US enrolment.

Viridis Mining and Minerals has achieved a critical environmental milestone with the granting of the Preliminary License for its Colossus Rare Earth Project in Brazil, significantly de-risking the development timeline and paving the way for construction in 2026.

Comet Ridge Limited has obtained federal environmental approval for its Mahalo North natural gas project, paving the way for expanded development in Queensland’s Bowen Basin. This milestone complements recent ownership consolidation and state approvals, positioning the company to boost east coast gas supply.

Clarity Pharmaceuticals has secured positive FDA guidance to initiate a pivotal Phase III trial of its Cu-64 SARTATE diagnostic agent for neuroendocrine tumours, aiming to improve detection and patient outcomes.

Mayne Pharma reports mixed early FY26 results with strong prescription growth in Women’s Health and improved Dermatology margins, while strategic reviews and litigation loom.

Memphasys has inked a five-year supply agreement with Italy’s Centro Fertilita Assistita, marking its first major European contract and setting the stage for broader adoption of its Felix™ sperm isolation system.