Latest Regulatory Approvals News

Emyria has presented its regulated Australian psychedelic-treatment experience to the US FDA, putting clinical delivery systems rather than drug development at the centre of its US ambitions. The appearance raises the company’s profile, but does not yet disclose regulatory approval, a commercial agreement or a financial commitment.

Reliance Worldwide Corporation has signed a binding scheme implementation deed for Brookfield to acquire all shares for US$3.38 each, equivalent to about A$4.75 at the stated exchange rate. The recommended deal now enters a limited window for rival proposals before shareholder, court and regulatory approvals are sought.

US1 Critical Minerals has agreed to transfer six Tanzanian uranium licences to Bradda Head Lithium for up to US$1.8 million, while retaining its Lilombe Project. The deal remains subject to regulatory approvals and other closing conditions.

Deep Yellow reported a A$13.3 million FY2026 profit and moved its Tumas uranium project closer to a targeted fourth-quarter investment decision. The company remains debt free, but acknowledges it will need external capital to fund construction.

Silver Mines says NSW planning authorities have reaffirmed that the Bowdens Silver Project is in the public interest and approvable subject to strict conditions. The Independent Planning Commission will resume its public hearing in October, with a final decision expected by 9 December 2026.

PolyNovo delivered 16.1% revenue growth and a sharp improvement in operating cash flow in FY26, despite a lower statutory profit after a prior-year tax benefit and a fire-related write-off. The ASX-listed wound-care company now expects to lodge its U.S. PMA application for NovoSorb BTM before the end of 2026.

Brightstar Resources will pay A$350,000 for five Panther Metals exploration licences beside its Laverton processing plant, securing ground needed for haul roads, water infrastructure and future tailings capacity. A separate, non-binding deal could also bring Panther’s Burtville East ore through the plant under a 50:50 net proceeds arrangement.

Cygnus Metals’ shareholder vote on Central Asia Metals’ proposed acquisition remains scheduled for 18 September, but Kazakhstan regulatory approval may arrive too late for the current court timetable. The transaction has cleared several major hurdles, while the directors continue to recommend it.

Western Gold Resources is pursuing multiple processing alternatives for Gold Duke after Wiluna Mining deferred third-party tolling, while revising the project’s study around a larger resource. The company is also considering corporate opportunities, but no processing agreement, transaction or expanded mine plan has been secured.

Dimerix has secured Mexican composition of matter protection for its Phase 2-ready kidney drug DMX-652 until June 2041. The grant expands the asset’s patent estate ahead of planned clinical testing in acute kidney injury, although it brings no new clinical data or regulatory approval.

Forte Energy has bought nine more months to secure funding for the required Idris Prospect well after regulators suspended work-program conditions on WA-424-P. The extension preserves the permit, but drilling finance and the prospect’s technical credentials remain unresolved.

Alcoa has filed South32’s meeting materials ahead of a shareholder vote on the proposed sale of bauxite, alumina and aluminium interests. The transaction remains subject to shareholder approval, regulatory clearance, financing and other closing conditions.