Latest Regulatory Approvals News

CLINUVEL Pharmaceuticals has completed recruitment for its Phase III trial of SCENESSE® in vitiligo patients with darker skin types, setting the stage for first results in late 2026. Early clinical observations suggest promising repigmentation outcomes.

Contact Energy has received clearance from the New Zealand Commerce Commission to proceed with its acquisition of Manawa Energy, marking a pivotal step in the country’s energy transition.

Western Yilgarn Limited has secured a significant new gold exploration area near the Glenburgh Gold Project in Western Australia, positioning itself alongside established players like Benz Mining Corp. The company is set to begin detailed geological and geophysical assessments to unlock the region’s potential.

Cardiex Limited has formally lodged its CONNEQT Pulse device with Australia's Therapeutics Goods Administration, marking a critical step toward regulatory approval and market expansion.

Silex Systems reports steady progress on its TRL-6 uranium enrichment demonstration, targeting completion by end-2025, while securing initial US government funding to support commercialisation efforts.

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.

Seven West Media has agreed to acquire Southern Cross Media's television licences, completing its national broadcast network and boosting its digital and live TV offerings across Australia.

Dimerix has received a US$30 million upfront payment from Amicus Therapeutics for exclusive US rights to DMX-200, a promising kidney disease therapy. The deal positions Dimerix for up to US$560 million in further milestones plus royalties, underpinning its global licensing strategy.

Spheria Emerging Companies Limited has updated its dividend distribution approach, opting to use cash dividends to buy shares on-market due to the share price falling below its post-tax NTA per share on the ex-dividend date.

Bio-Gene Technology Limited is progressing its development of two novel insecticidal compounds, Qcide and Flavocide, targeting major global markets with strong commercial validation and significant US Department of Defense funding.

Anax Metals has locked in a $3.3 million convertible note investment from Mineral Development Partners, with conditional commitments for up to $100 million to advance the Whim Creek Project and establish a Pilbara base metals hub.

Bio-Gene Technology Limited has raised $2.1 million through a placement and launched a Share Purchase Plan to fund critical safety studies for its flagship insecticide Flavocide®, alongside development of Qcide and strategic initiatives.