Latest Regulatory Milestones News

Invion Limited secures a pivotal FDA Orphan Drug Designation for its lead candidate INV043, targeting anal cancer with promising preclinical results and a fast-tracked development path.

Invion Limited has disclosed that the US FDA granted Orphan Drug Designation for its lead cancer drug candidate INV043, explaining recent unusual trading activity in its shares. The company confirmed it was unaware of the FDA decision prior to its public release and has now complied with continuous disclosure rules.

Star Minerals Limited will have its trading suspension lifted on 19 August 2025 following the release of important assay results and its response to an ASX Price Query.

Challenger Gold’s Argentinian subsidiary has obtained the crucial explosives permit to begin drill and blast operations for toll milling at the Hualilan Gold Project, unlocking near-term cash flow potential. The company’s recent Pre-Feasibility Study underscores robust economics, setting the stage for accelerated development.

Lake Resources has tapped its At-the-Market facility to raise A$1.575 million, aiming to fund key development stages of its flagship Kachi lithium project in Argentina.

Lumos Diagnostics has submitted its CLIA waiver application for FebriDx® to the FDA, backed by strong clinical data and triggering significant milestone payments. Approval could expand the U.S. market opportunity fifteen-fold to over $1 billion.

VBX Limited strengthens its leadership and advances drilling programs at the Wuudagu bauxite project, setting the stage for a pivotal Definitive Feasibility Study and environmental approvals.

National Australia Bank’s June quarter saw a slight dip in cash earnings due to rising credit impairment charges, even as underlying profits edged up 2%. The bank balances cautious asset quality management with ongoing growth in lending and deposits.

Alice Queen Limited has formally lodged a 15-year mining lease application for its Horn Island Gold Project, marking a significant step forward in its decade-long exploration journey and attracting strong partnership interest.

Laramide Resources has made significant progress in advancing its uranium projects across the US, Australia, and Kazakhstan, highlighted by key permitting milestones under the US FAST-41 framework and a successful $12 million private placement to fund development.

Laramide Resources Ltd. reported a reduced net loss of CAD 1.05 million for H1 2025, converting USD 3.5 million of debt into equity and securing a $12 million private placement to bolster its uranium exploration projects.

Lunnon Metals has reported robust metallurgical test results for its Lady Herial gold deposit, confirming strong gold grades and recoveries that align with recent economic studies. These findings bolster the project’s development prospects amid ongoing negotiations with Gold Fields.