Latest Regulatory Submissions News

Tetratherix Limited has marked a pivotal quarter with a $25 million ASX listing, an exclusive licensing agreement with Bio Optix for ophthalmic devices, and progress on FDA regulatory submissions for its prostate spacer product.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

29Metals Limited's June Quarter 2025 report highlights steady production at Golden Grove with revised capital guidance, while Capricorn Copper remains suspended but progresses on key environmental and regulatory fronts.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Orthocell Limited has reported a record FY2025 revenue of A$9.19 million, driven by strong sales of its nerve repair product Remplir™ in Australia and a promising US market launch following FDA clearance.

Medallion Metals reports standout gold and copper assays from Harbour View infill drilling, reinforcing resource confidence ahead of a July update and advancing its strategic Forrestania acquisition.

Lincoln Minerals has identified multiple high-priority drill targets at its Minbrie Copper-Base Metals Project in South Australia, with drilling approvals advancing for a campaign planned in the second half of 2025.

Capricorn Metals capped FY25 with a strong Q4 at Karlawinda, delivering gold production at the upper guidance range while pushing forward major development milestones.

Neurizon Therapeutics has inked a pivotal global licensing deal with Elanco Animal Health, unlocking critical intellectual property and data to accelerate the development and commercialisation of its lead drug candidate NUZ-001 for neurodegenerative diseases including ALS.

EMVision Medical Devices has activated five of six pivotal trial sites for its emu™ bedside brain scanner, advancing towards FDA clearance while launching a parallel innovation study in Australia.

West Cobar Metals has initiated approvals for a 5,000m air core drilling campaign at its promising Mystique Gold Project, aiming to unlock significant gold mineralisation in Western Australia’s Fraser Range.

Optiscan Imaging Ltd has commenced a landmark clinical study at Royal Melbourne Hospital, testing its cutting-edge InVue® and InForm™ devices to improve breast cancer surgery precision. The study aims to generate critical data for US FDA approval and could redefine surgical oncology workflows.