Latest Regulatory News

PointsBet Holdings has formalised a conditional takeover bid deed with MIXI at $1.20 per share, activating if shareholders reject the current scheme of arrangement. The deal hinges on key regulatory approvals and a minimum 50.1% acceptance threshold.

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Nyrada’s Phase I clinical trial for its novel drug Xolatryp has cleared safety reviews through four cohorts and will now test higher doses and longer infusions in an expanded trial design.

Gibb River Diamonds has successfully completed a heritage survey over the proposed open pit at its Neta Prospect, removing a key obstacle to mining development within the Edjudina Gold Project. The project moves closer to production with mining costs borne by a private contractor.

Santos Limited has received a compelling non-binding proposal from the XRG Consortium to acquire the company at a significant premium, prompting the board to engage in due diligence and negotiations. This move could reshape the Australian energy landscape if finalized.

EVE Health Group’s subsidiary Nextract has inked a pivotal two-year agreement with TeleDocs Clinic, enabling nationwide online prescribing of its upcoming erectile dysfunction and dysmenorrhea products ahead of regulatory approval.

IRIS Metals has reported promising high-grade lithium intersections from its Phase I drilling at the Edison Project in South Dakota, reinforcing its strategy to develop a centralized lithium processing hub in the US.

Amplia Therapeutics has reported a rare pathological complete response in a patient from its ACCENT trial, highlighting promising potential for its drug narmafotinib in treating advanced pancreatic cancer.

EMVision Medical Devices has secured a $5 million non-dilutive government grant to accelerate global commercialisation of its innovative First Responder portable brain scanner, aimed at revolutionising pre-hospital stroke and brain injury care.

Talga Group’s Nunasvaara South graphite mine zoning plan process shifts to regional government after local deadline missed, advancing a key step in Sweden’s battery materials push.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Lunnon Metals has completed a detailed Scoping Study for its Lady Herial gold deposit, confirming a short-life, high-grade open pit opportunity with strong financial prospects. The study, based largely on Measured and Indicated Resources, sets the stage for commercial negotiations with Gold Fields and potential near-term production.