Latest Regulatory Approvals News

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

Neurotech International has secured a Rare Pediatric Disease Designation from the FDA for its lead drug NTI164 targeting Rett syndrome, alongside publishing promising clinical data and raising $8.7 million to fuel further development.

The Calmer Co has posted a record $2.01 million in sales for Q2 FY26, propelled by a 9% increase in US revenue which now accounts for over half of the group’s total income. Strong retail and wholesale growth underpin the company’s expanding footprint in the natural relaxation market.

Lithium Plus Minerals has secured a 20-year mining lease for its Lei Lithium Project and progressed key environmental and mining studies, while also preparing exploration programs for its gold and critical minerals projects.

Conrad Asia Energy and Empyrean Energy have reached a binding settlement over historical cash call arrears in the Duyung Production Sharing Contract, involving asset transfers and payments that realign project interests and support the Mako gas field’s development timeline.

Zoono Group has landed its first commercial orders from three new packaging partners, marking a key milestone in its fresh food shelf-life extension strategy. The company reports NZ$551,000 cash on hand as it navigates growth and funding options.

Australian United Investment Company Limited (AUI) has entered into a binding agreement to merge with Diversified United Investment Limited (DUI) through a share exchange scheme, aiming to enhance liquidity, reduce costs, and maintain dividends.

Top End Energy advances its Serpentine hydrogen project and Beetaloo gas exploration while pivoting to power land development for the booming US AI data center sector.

Galilee Energy has secured the Zydeco Gas Project in Louisiana and raised $6.5 million to fast-track development, marking a pivotal shift towards becoming a mid-tier US gas producer.

Lake Resources NL reported a solid quarter ending December 2025, progressing regulatory approvals for its Kachi Lithium Brine Project while slashing cash outgoings by 45% year-on-year and maintaining strong liquidity amid a sharp lithium price rally.

Bio-Gene Technology Limited reports strong progress in advancing its Flavocide® and Qcide® insecticidal platforms, backed by US Department of Defense funding and key organic certification in the US.

Critical Resources Limited has significantly expanded its Mavis Lake Lithium Project in Ontario and progressed gold exploration in New Zealand, while securing exclusive rights to evaluate cutting-edge solid-state battery technology.