Latest Regulatory Approval News

EMVision Medical Devices has activated two additional key sites in its pivotal trial for the emu™ bedside brain scanner, advancing its path toward FDA clearance. These new sites join a growing network of leading stroke centres across the US and Australia.

James Hardie Industries has successfully syndicated $3.5 billion in new credit facilities, providing robust financial backing for its planned merger with The AZEK Company Inc. This move significantly reduces prior bridge loan commitments and enhances the company’s financial flexibility.

Neurotech International has reported positive human pharmacokinetic results for NTI164, a cannabinoid formulation designed for paediatric neurological disorders, confirming rapid absorption and a non-intoxicating profile.

EV Resources Limited has agreed to sell its Yanamina Gold and Silver Project in Peru to Daura Gold Corp for US$6 million, a move that will bolster EVR’s cash reserves and sharpen its strategic focus.

Redivium Limited has secured a definitive five-year marketing and offtake agreement with WMC Energy BV, ensuring exclusive global sales of black mass from its UK battery recycling facility.

Lumos Diagnostics has reached 50% recruitment of bacterial positive patients in its pivotal FebriDx CLIA waiver clinical study, setting the stage for a planned FDA submission in late 2025 and unlocking a substantial US market opportunity.

Firetail Resources has secured exclusive options to acquire two promising gold projects in Nevada and South Dakota, expanding its footprint in premier North American gold districts.

EVE Health Group has initiated stability testing for its novel oral treatments targeting erectile dysfunction and dysmenorrhea, marking a crucial step toward regulatory approval in Australia. The company also finalizes its acquisition of Nextract, the developer behind these innovative formulations.

Soul Patts and Brickworks have announced a transformative merger to create Washington H. Soul Pattinson, a new $14 billion ASX-listed company. The deal simplifies ownership, boosts liquidity, and offers shareholders a premium on Brickworks shares.

Washington H. Soul Pattinson and Brickworks Limited have agreed to merge, creating a $14 billion ASX-listed entity that promises greater scale, liquidity, and diversification for shareholders.

Ballard Mining Limited is set to raise $25-$30 million through an IPO to advance the Mt Ida Gold Project, boasting a 1.1 million ounce resource and significant exploration upside. The move follows a strategic demerger from Delta Lithium, positioning Ballard as a focused gold developer with an experienced leadership team.

Delta Lithium Limited has announced a proposed demerger involving an in-specie distribution of over 63 million Ballard Mining shares to eligible shareholders, pending approval at a June 30 meeting. This move will reduce Delta's stake in Ballard and set the stage for Ballard's eventual ASX listing.