Latest Regulatory Approval News

Bubs Australia reported a 30% increase in net revenue to $25.6 million for Q1 FY26, driven by robust US sales and a return to profitability with positive EBITDA. Despite inventory challenges in other regions, the company maintains a solid cash position and anticipates FDA approval by year-end.

PainChek Ltd has achieved a pivotal FDA De Novo clearance for its AI-driven Adult pain assessment app, unlocking the US market and driving its annual recurring revenue to $5.6 million. The company also launched its Infant app, targeting a vast global market of pre-verbal children.

PainChek has secured FDA De Novo clearance for its Adult App, opening immediate access to a $175 million AUD US long-term care market and advancing its Infant App commercialization targeting a $15 billion AUD global opportunity.

Race Oncology has filed pivotal patents on the active (E,E)-bisantrene isomer, potentially extending its drug exclusivity by two decades, while advancing its Phase 1 clinical trial and maintaining a strong cash position.

Taiton Resources has completed key soil sampling programs targeting gold and rare earth elements at its South Australian projects, alongside heritage surveys and regulatory steps, supported by a recent $2 million capital raise.

Sarytogan Graphite Limited reports strong progress in graphite and copper exploration, securing key DFS contracts and a $3.6 million placement to advance its flagship projects.

Nova Eye Medical reported a robust 32% increase in global sales excluding China for Q1 FY26 and secured regulatory approval for its iTrack™ Advance device in China, setting the stage for expanded market penetration.

AGL Energy has agreed to purchase four new gas turbines for $185 million to develop the Kwinana Swift Gas 2 project, securing 176MW of reserve capacity to support Western Australia’s energy transition.

Silver Mines Limited progresses regulatory approvals for its flagship Bowdens Silver Project in NSW, secures $34 million through capital raising, and acquires promising US exploration assets, setting the stage for growth.

Orange Minerals reports exceptional silver grades at its Lennon’s Find project in WA and advances its strategic acquisition in Ghana, while expanding its investor reach with a US market listing.

Sun Silver Limited reports significant drilling success at its Maverick Springs silver-gold project, backed by a $30 million capital raise and plans for a U.S. OTC listing to broaden investor access.

SkyCity Entertainment Group reported a decline in FY25 revenue and earnings but remains confident in its FY26 outlook, underpinned by cost savings and strategic initiatives.