Latest Regulatory Approvals 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.

Cygnus Metals has sent out the Scheme Booklet to shareholders detailing the proposed acquisition by Central Asia Metals, with directors recommending approval ahead of the September vote.

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.

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.

Global Lithium Resources has secured critical environmental and water permits for its Manna Lithium Project, clearing the way for early works and construction. These approvals align with the company’s aggressive schedule targeting first ore shipment in mid-2027.

Medical Developments International (ASX:MVP) reported a 9% revenue increase to $42.6 million and a 566% jump in net profit to $0.6 million for FY26, driven by robust growth in its Pain Management segment and expanded paediatric approvals in Europe.

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.