Latest Regulatory News

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Core Lithium's Restart Study for the Finniss Lithium Operation confirms a 20-year underground mine life with significant cost reductions and enhanced production capacity.

Lumos Diagnostics has secured its largest single US purchase order for its rapid respiratory test FebriDx, signaling growing adoption in American healthcare settings.

Core Lithium has doubled the Grants Ore Reserve by shifting to underground mining, lifting total Finniss Ore Reserves to 10.73 million tonnes at 1.29% lithium oxide. This update supports a robust 10-year mine plan with potential for extended operations.

Savannah Goldfields has announced a new gold Exploration Target at its Electric Light Deposit within the Georgetown Project, potentially extending known mineralisation and supporting its processing plant feed strategy.

QBE Insurance Group has announced plans to issue AUD subordinated notes as part of its capital management strategy, aiming to strengthen its Tier 2 capital base. Details on pricing and timing will follow, contingent on market conditions.

Anteris Technologies has submitted its FDA Investigational Device Exemption for the pivotal PARADIGM Trial of its DurAVR heart valve and marked a milestone of 100 patients treated, while expanding manufacturing capacity amid rising R&D costs.

Tamboran Resources has finalized a US$15 million sale of 100,000 acres to Daly Waters Energy, retaining a dominant 1.9 million-acre position in the Beetaloo Basin and setting the stage for its Phase 2 gas development targeting Australia's East Coast market.

Tamboran Resources has raised US$55.4 million through a private placement to fund critical drilling activities in the Beetaloo Basin, aiming for first gas production by mid-2026.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.

Aristocrat Leisure Limited has announced an ordinary unfranked dividend of AUD 0.44 per share for the six months ending March 2025, with key dates set for May and July.

Asra Minerals has executed a binding agreement to acquire the remaining 49% interest in the Mt Cutmore prospects, consolidating full ownership of a significant gold resource within the prolific Leonora North Gold Project.