Latest Regulatory Milestones News

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.

Meteoric Resources has obtained the Preliminary Environmental Licence without restriction for its Caldeira Rare Earth Ionic Clay Project in Brazil, clearing a key regulatory hurdle and keeping the project on track for mid-2026 construction.

Telix Pharmaceuticals reports positive Phase 3 results for its prostate cancer imaging agent Illuccix in China, paving the way for a near-term regulatory submission. Meanwhile, the company advances FDA resubmissions for its glioma and kidney cancer imaging candidates.

ASPI Isotopes Inc. and Renergen Limited have received regulatory clearance to proceed with their Scheme of Arrangement, setting a detailed timetable for share suspensions, listings, and settlements complicated by cross-border processes.

Native Mineral Resources has secured the Estimated Rehabilitation Cost decision, unlocking mining activities at the Podosky site with drilling set for January 2026 and ore processing targeted by late February.

Micro-X Limited has secured $6 million through a share placement to accelerate commercialisation of its innovative medical imaging technologies, with strategic partner Billion Prima increasing its stake to 8.5%. The capital raise supports key clinical trials and product development milestones.

Memphasys Limited’s partner International Technical Legacy has placed an early order for 500 Felix™ cartridges ahead of anticipated CE Mark approval, signalling strong clinic demand and validating the company’s direct-selling strategy in the Middle East.