Latest Regulatory News

Galan Lithium has completed a $20 million placement and secured Argentine government incentives, advancing its Hombre Muerto West lithium project toward first production in early 2026.

Argenica Therapeutics reports ARG-007 is safe in acute ischemic stroke patients and shows promising efficacy signals in a high-risk subgroup, paving the way for a focused Phase 2b trial.

Invion Limited has secured a pivotal FDA Orphan Drug Designation for its lead cancer drug INV043, bolstered its balance sheet with nearly $1.8 million in new funding, and progressed clinical trials targeting skin and anogenital cancers.

BCAL Diagnostics has secured key partnerships and a $10 million convertible note facility to expand its cancer detection tests across Australia and New Zealand, marking steady commercial progress in Q3 2025.

Green360 Technologies has independently verified its Eco-Clay product as a high-performance, low-carbon cement substitute made from kaolin waste, poised to disrupt Australia’s $3.5 billion cement market.

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.

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.

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.

Polymetals Resources Ltd has had its trading suspension lifted following an announcement about a serious safety incident at its Endeavor Mine Site, raising questions about operational impacts and regulatory responses.

Jindalee Lithium is progressing its McDermitt Lithium Project with a proposed US SPAC listing, government backing, and an $8 million capital raise, positioning it as a key player in the US critical minerals landscape.

Polymetals Resources has reported a fatal underground incident at its Endeavor Mine in NSW, resulting in two deaths and a suspension of operations as investigations proceed.