Latest Regulatory Progress News

Credit Intelligence Ltd has agreed to sell its 60% stake in the loss-making subsidiary OneStep Information Technology Limited for a nominal sum, expecting a modest gain. This move aligns with its strategic pivot towards profitable ventures amid ongoing ASX suspension challenges.

Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.

Alligator Energy advances regulatory approvals and construction preparations for its Samphire Uranium Project’s Field Recovery Trial, a critical step toward commercial production.

4DMedical has renewed and expanded its contract with Stanford University’s 3DQ Lab to include its innovative CT – VQ™ imaging technology ahead of FDA clearance, marking a significant step in its U.S. market expansion.

Lunnon Metals has completed a detailed Scoping Study for its Lady Herial gold project, highlighting a high-grade open pit opportunity underpinned by predominantly measured resources. The company is advancing commercial negotiations and regulatory approvals, setting the stage for potential near-term development.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Platinum Capital Limited has taken a significant step towards restructuring by lodging a draft scheme booklet to convert shareholder investments into an active ETF, aiming to resolve its persistent discount to net tangible assets.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.

PointsBet has secured a significantly improved acquisition proposal from MIXI, lifting the cash offer by 13.2% to $1.20 per share and postponing the shareholder vote to June 25. The move intensifies the takeover battle amid ongoing regulatory approvals and a rival bid from Betr Entertainment.

Lake Resources N.L. has upgraded its Kachi lithium brine resource in Argentina, increasing the Measured and Indicated lithium carbonate equivalent to 8.2 million tonnes, supported by new drilling data and enhanced lithium recovery technology.

Titanium Sands Limited has locked in a $600,000 convertible loan facility from major shareholders to fund environmental studies and progress its Mannar Heavy Mineral Project. This funding milestone follows recent regulatory approvals and marks a critical step forward for the company.

Paradigm Biopharmaceuticals has reached key milestones in its global Phase 3 trial for knee osteoarthritis, activating its first Australian clinical site and enrolling the first patient. With multiple sites in Australia and the US preparing for recruitment, the trial is advancing steadily toward critical data readouts.