Latest Regulatory Clearance 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.

Regis Resources has significantly increased Ore Reserves at its Buckingham-Wellington pits, extending Duketon North’s mine life and boosting production prospects with minimal new capital investment.

Seven West Media shareholders are preparing to vote on a scheme of arrangement for acquisition by Southern Cross Media Group, with the Seven board unanimously recommending approval. The merger promises significant cost synergies and a stronger combined media platform.

Global Uranium and Enrichment Limited has entered a new funding agreement with Summit Strategies LLC, raising an additional A$2.5 million through convertible notes to support its ongoing operations and merger obligations with Snow Lake Resources.

Memphasys Limited has successfully raised over $1.1 million through a pro-rata entitlement offer to accelerate the commercialisation of its innovative Felix™ sperm selection system, targeting key regulatory approvals and market expansion.

Jade Gas Holdings has signed a non-binding Letter of Intent with Chinese partner Langrun for up to A$70 million in non-dilutive financing to fast-track its Red Lake LNG project in Mongolia. This deal could significantly advance drilling, production, and gas processing operations.

AVITA Medical reported a 13% drop in Q3 commercial revenue to $17.1 million but improved its net loss and secured CE Mark approval for RECELL GO in Europe, signaling strategic shifts ahead.

SQX Resources has validated and surpassed historical gold grades at its Red Bird Project in Arizona, with assays reaching 49.2 g/t Au. A maiden drilling campaign is planned for January 2026 to explore this promising gold system further.

Bayan Mining has secured US Bureau of Land Management approval for its Desert Star Project in California, paving the way for field activities and a planned drilling program in 2026. The project’s proximity to major rare earth and gold mines underscores its strategic potential.

Mayne Pharma updates shareholders on the extended Foreign Investment Review Board approval deadline and the rescheduled court hearing for its acquisition scheme by Cosette Australia BidCo.

Pepper Money and KKR have agreed to acquire Westpac’s RAMS home loan portfolio, marking a significant move in Australia’s mortgage servicing landscape. The $21.4 billion portfolio acquisition aligns with Pepper Money’s strategy to expand its capital-light servicing business.