Latest Regulatory Approvals News

Lumos Diagnostics has hit a key enrollment milestone in its BARDA-funded paediatric study for FebriDx®, unlocking a US$720,000 payment and edging closer to FDA expansion.

Neurotech International has reported positive long-term safety results for its lead drug candidate NTI164, bolstering its path towards regulatory approval and chronic use in paediatric neurological disorders.

Toubani Resources has obtained the crucial environmental permit for its Kobada Gold Project, clearing the way for construction and initiating resettlement activities as planned.

Bindi Metals has secured regulatory approval to commence its maiden drilling program at the Ravni Gold Project in Serbia, while historic drill core resampling is underway with assay results expected soon.

EMVision Medical Devices reported a $3.97 million loss for H1 2026, up 11% year-on-year, driven by increased share-based payments and expanded clinical activities. The company secured a $3 million government grant to advance stroke diagnosis in regional Australia.

Greatland Resources posted a robust half-year profit of $342.9 million, driven by full ownership of the Telfer mine and a strong operational ramp-up. The Havieron feasibility study confirms a world-class gold-copper project, setting the stage for future growth.

QMines Limited has significantly upgraded its Develin Creek Mineral Resource, increasing Indicated Resources by 46% and total resources by 14%, setting the stage for Phase 2 development planning.

Minerals 260 has locked in a $220 million strategic funding deal with Franco-Nevada, boosting development and de-risking the Bullabulling Gold Project in Western Australia. This marks Franco-Nevada’s largest Australian investment to date.

Nuix Limited has reported robust half-year results for 1H26, highlighted by a 148% increase in Nuix Neo Annualised Contract Value and a significant boost in profitability and cash flow.

Stanmore Resources delivered record coal production and strong cash flow in 2025 despite softer market prices, declaring a fully franked dividend and guiding a modest production decline for 2026.

Osmond Resources has partnered with Técnicas Reunidas to establish the European Union’s first vertically integrated rare earth production facility, aiming to reduce reliance on imports and boost local supply chains.

Hartshead Resources has updated the schedule for its proposed acquisition by ACAM GP Limited, with key shareholder and court dates set through May 2026. The revised timetable outlines the next steps in the scheme of arrangement process.