Latest Regulatory Approvals News

Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.

Anteris Technologies Global Corp. reported a $22.2 million loss in Q3 2025 while progressing its DurAVR Transcatheter Heart Valve pivotal trial following key regulatory approvals. The company bolstered its cash position with a $25.2 million private placement post-quarter.

Superior Resources Limited has lodged a transaction specific prospectus to offer 1,000 new shares at $0.01 each, enabling previously issued shares to be sold without further disclosure. The move addresses regulatory compliance while raising minimal funds.

Star Minerals has inked a pivotal Right to Mine Agreement with MEGA Resources and Bain Global Resources, unlocking $20 million in funding and operational support for its Tumblegum South Gold Project, aiming for production in early 2026.

GrainCorp Limited has declared a combined ordinary and special dividend of AUD 0.24 per share, fully franked, reflecting confidence in its recent financial performance.

Ausgold Limited’s Katanning Gold Project has been fast-tracked through Western Australia’s new Priority Approvals Program, marking a key step toward a mid-2026 Final Investment Decision.

Superior Resources has updated its Mineral Resource Estimate for the Steam Engine Gold Project, confirming a substantial 194,000 oz gold resource and revealing significant exploration potential along an additional 10 kilometres of prospective lodes.

Canterbury Resources and Alma Metals have completed a positive Scoping Study for the Briggs Copper Project, confirming a 2Mt copper resource and strong metallurgy. Prefeasibility studies are now underway to refine resource confidence and project economics.

Rox Resources has released a Definitive Feasibility Study for its Youanmi Gold Project, revealing a high-grade reserve and strong financial metrics underpinning a planned 7-year mine life with significant growth potential.

EBR Systems has achieved a major commercial milestone with Medicare reimbursement approvals for its wireless cardiac pacing WiSE CRT System, driving a 201% revenue increase in Q3 2025. The company is advancing its Limited Market Release as it scales adoption in the US.

Sandfire Resources and Havilah Resources have sealed a binding agreement that could transform the Kalkaroo Copper-Gold Project into one of Australia’s next major copper provinces through a substantial earn-in deal and strategic exploration alliance.

New Frontier Minerals has lodged a mining lease application for the Big One Copper Deposit in Queensland’s Mt Isa belt, aiming for first production in early 2027. The move solidifies tenure over a key copper asset and advances plans for open-cut mining with processing through Austral Resources’ Mt Kelly facility.