Latest Regulatory Approvals 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.

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.

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.

Tourism Holdings Limited has received a conditional, non-binding takeover proposal from a consortium led by BGH Capital and the Trouchet family, signaling a possible shift in ownership for the global RV rental giant.

VBX Limited is set to raise $10 million through an initial public offering to fund the development of its Wuudagu Bauxite Project in Western Australia, supported by a positive pre-feasibility study and strong market fundamentals driven by China’s growing aluminium demand.

Yowie Group Ltd has initiated an off-market takeover bid to acquire Keybridge Capital Limited, offering one Yowie share for each Keybridge share amid Keybridge's financial distress and administration history.

Silk Logistics has announced a postponement of its shareholder Scheme Meeting due to an extended review by the Australian Competition and Consumer Commission (ACCC) of DP World Australia’s proposed acquisition.