Latest Regulatory Progress News

Predictive Discovery’s Definitive Feasibility Study for the Bankan Gold Project confirms robust economics with a 12.2-year mine life producing 250,000 ounces annually and a post-tax NPV of US$1.6 billion. The study outlines a clear path to construction and production in Guinea, backed by strong financial returns and environmental approvals.

Capricorn Metals has extended its mining contract with MACA Ltd for Karlawinda and named MACA preferred contractor for Mt Gibson, locking in cost certainty and supporting production growth.

Amplia Therapeutics has secured US ethics approval to launch a Phase 2 trial combining its drug narmafotinib with FOLFIRINOX chemotherapy for advanced pancreatic cancer, marking a key step in its clinical development.

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.