Latest Regulatory Approvals News

Atomo Diagnostics stands to gain significantly as Lumos Diagnostics’ FebriDx test secures FDA CLIA waiver approval, vastly expanding its US market potential. This regulatory milestone triggers substantial contracted revenues and prompts Atomo to ramp up production.

The Star Entertainment Group has locked in a binding refinancing agreement with WhiteHawk Capital Partners, securing US$390 million to refinance existing debt and boost liquidity. This move aims to stabilise the company’s financial footing ahead of key regulatory approvals and asset sales.

Rimfire Pacific Mining has exercised its option to acquire 100% of the Rabbit Trap Scandium Project, consolidating its position in a promising scandium resource in central NSW. Recent drilling results underpin the acquisition, highlighting significant mineralisation and growth potential.

Boab Metals has received the crucial regulatory green light for its Sorby Hills project, clearing the way for full-scale mining operations and first concentrate production targeted in late 2027.

Mamba Exploration has integrated historic airborne electromagnetic data with a major soil sampling program at its Meeka East Gold Project, confirming promising gold anomalies and setting the stage for a maiden drilling campaign.

Excelsior Capital Limited has announced a further fully franked special dividend of over $10 million amid its ongoing winding up process, alongside key board changes and plans for final capital returns.

AMP Limited has announced a $150 million on-market share buyback set to begin after its first-quarter cashflow release in April 2026, signalling a strategic focus on shareholder returns and organic growth.

iCandy Interactive has announced plans for Lemon Sky Studios to pursue a US IPO on the NYSE American, targeting a US$15 million capital raise, while highlighting strategic pivots in AI and blockchain markets.

Lumos Diagnostics has secured a pivotal US FDA CLIA waiver for its FebriDx® test, vastly expanding its market reach and triggering milestone payments that bolster its US commercial rollout.

Bass Oil reported steady February production with some operational setbacks in the Cooper Basin, while gaining regulatory approval for the Vanessa gas field acquisition and securing government funding for Kiwi gas development.

4DMedical has achieved CE Mark certification for its groundbreaking CT:VQ™ ventilation-perfusion imaging technology, unlocking the vast European market. The company also raised $83 million to fund rapid expansion across the EU.

AdAlta’s subsidiary AdCella has completed its first Joint Development Committee meeting with Shanghai Cell Therapy Group, advancing the development of the CAR-T therapy BZDS1901 with potential timeline acceleration and reduced regulatory risks.