Latest Regulatory Approval News

Prodigy Gold NL is transitioning from exploration to development, underpinned by a robust scoping study at Hyperion and progressing approvals to restart mining at Twin Bonanza's Old Pirate mine.

Cleo Diagnostics (ASX:COV) posted a 48% jump in annual loss to $5.9 million amid key progress in its ovarian cancer diagnostic test, including completion of a pivotal US trial and preparations for FDA 510(k) submission.

Vault Minerals delivered a standout FY26 with a 54% jump in underlying EBITDA to $953 million, underpinned by strong gold prices and operational discipline. The company is on track to merge with Genesis Minerals, setting the stage for a new Australian gold powerhouse.

Loyal Metals Limited shareholders have given the green light to a scheme of arrangement for PT Bumi Resources to acquire the company at A$0.45 per share, pending final court approval and other conditions.

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.