Latest Regulatory Approval News

Pacific Edge’s draft Medicare Local Coverage Determination for its Cxbladder bladder cancer tests marks a pivotal step toward unlocking a $10.2 billion global market. Despite FY26 setbacks, the company is poised for growth with improved reimbursement prospects and strategic cost management.

Finder Energy’s KTJ offshore development in Timor-Leste has achieved a key milestone with an independent classification of 22.2 million barrels of 2P reserves, underpinning its push toward a Final Investment Decision.

Dimerix has received a US$10 million upfront payment from Everest Medicines under a regional licensing deal for DMX-200 targeting FSGS in Greater China, South Korea and Southeast Asia. This deal marks Dimerix’s fifth commercial partnership for DMX-200, collectively worth up to A$1.9 billion in milestones and royalties.

CZR Resources Ltd (ASX:CZR) has launched an all-scrip off-market takeover bid for Zuleika Gold Limited (ASX:ZAG), offering 0.1742 CZR shares per Zuleika share, valuing Zuleika at approximately $44.8 million and representing a premium of over 40% to recent prices.

Zip Co Limited (ASX: ZIP) reported a 46% rise in net profit to $116.4 million for FY26, driven by strong US and ANZ market growth and record cash earnings of $268.9 million. The company also announced an orderly wind down of its New Zealand operations to focus on its core markets.

Memphasys has cleared a key regulatory hurdle in Vietnam for its Felix™ System, prompting a significant first commercial cartridge order and marking early clinical success in a fast-growing fertility market.

Maritana Minerals (ASX:MRT) has reported a 6.3% rise in gold Mineral Resources to 1.86 million ounces and a striking 148% increase in Ore Reserves to 204,100 ounces for FY2026, driven by maiden Ore Reserves at Crake and Kalpini and updates at Boorara.

Fortescue Ltd delivered a record 201.3 million tonnes of iron ore in FY26, alongside a 3% rise in underlying net profit after tax to US$3.47 billion, despite a significant $750 million impairment charge on its Iron Bridge asset. The miner declared a fully franked final dividend of A$0.46 per share and continues to advance its ambitious decarbonisation and growth agenda.

SkyCity Entertainment Group reported a 22% drop in underlying EBITDA for FY26, impacted by regulatory costs and carded play rollout, while progressing asset sales and preparing for New Zealand's online casino market.

Loyal Metals (ASX:LLM) schedules a key court hearing on 24 August to approve PT Bumi Resources’ A$79 million takeover scheme, with most conditions including shareholder approval and project acquisitions progressing smoothly.

Audalia Resources has raised $450,000 through a placement of 15 million shares at 3 cents each, aiming to push the Medcalf project towards production while maintaining working capital.

Energy Fuels Inc. reported a transformative 2024 with a major acquisition boosting its heavy mineral sands assets, a uranium production ramp-up at key US mines, and commercial rare earth oxide output from its White Mesa Mill.