Latest Regulatory Clearance News

Cleanaway Waste Management has received regulatory clearance from the ACCC to acquire Citywide, marking a significant step in its expansion strategy with completion expected by fiscal year-end 2025.

Euro Manganese advances its Chvaletice manganese project with key regulatory approvals, leadership appointments, and a $9.8 million capital raise, while reporting a narrowed Q3 net loss.

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.

PolyNovo has secured Therapeutic Goods Administration clearance for thicker versions of its NovoSorb MTX product, broadening treatment options for complex wounds in Australia.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

Orthocell has secured regulatory approval to sell its nerve repair product Remplir™ in Hong Kong well ahead of schedule, expanding its footprint across key global markets. This milestone complements recent clearances in the US, Canada, and Asia, positioning the company for significant growth in a multi-billion-dollar market.

AVJennings Limited has announced a proposed $0.655 per share acquisition scheme by PM Nominees C Pty Ltd, an investment vehicle of Proprium Capital Partners and AVID, offering shareholders a near 100% premium over recent trading prices. The scheme, supported unanimously by the board and an independent expert, awaits shareholder and court approval.

Aguia Resources reports steady underground mining at 15 tonnes per day at its Santa Barbara Gold Project, with plans to boost processing capacity to 50 tonnes per day by July 2025 and imminent gold sales.

Dropsuite secures Foreign Investment Review Board approval for its acquisition by NinjaOne, clearing a major regulatory hurdle ahead of the upcoming shareholder vote. Meanwhile, ASIC grants an extension for Dropsuite’s 2025 AGM, reflecting the pending transaction timeline.

James Hardie Industries plc has entered a definitive merger agreement to acquire The AZEK Company Inc. in a $7.8 billion deal, creating a combined leader in outdoor living and home exteriors. The transaction, expected to close in the second half of 2025, will see AZEK stockholders owning approximately 26% of the combined company.

OD6 Metals has secured regulatory approval to resume exploration at its historic Gulf Creek Copper Project in NSW, with assay results from six completed drill holes expected soon to shape future programs.

Southern Cross Gold Consolidated Ltd has successfully arranged a C$143 million private placement, positioning the company to accelerate development of its Sunday Creek Gold-Antimony Project in Victoria, Australia.