Latest Regulatory 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.

Kingsrose Mining’s December quarter report reveals steady progress in its Finnmark exploration alliance and a significant permitting hurdle at its Penikat project in Finland. The company maintains a solid cash position as it plans for 2026 drilling campaigns.

Neurizon Therapeutics has cleared a major regulatory hurdle with the FDA lifting the clinical hold on its lead drug NUZ-001 and secured a comprehensive $33 million funding package to advance its pivotal ALS trial.

Entropy Neurodynamics has successfully enrolled and dosed the first patient in its pioneering clinical trial of TRP-8803, an intravenous psilocin formulation targeting Binge Eating Disorder, while securing $6.1 million in new funding to accelerate development.

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.

Besra Gold Inc has updated its Bau Gold Project resource estimate and is intensifying efforts to secure critical mining lease renewals, while restructuring its operations to sharpen capital discipline and technical oversight.

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.

The Calmer Co. International Limited has reported a second consecutive quarter of revenue exceeding $2 million, driven by strong U.S. growth and record monthly sales in December. The company’s strategic focus on wholesale and B2B extract channels underpins its confidence in reaching breakeven this fiscal year.

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.

Percheron Therapeutics has reported encouraging safety and efficacy signals from its HMBD-002 phase I trial, and outlined an innovative modular phase II trial design targeting multiple cancers in 2026.

88 Energy Limited has significantly expanded its Alaskan North Slope acreage and progressed its farm-out strategy despite regulatory delays, while maintaining a solid cash position to support ongoing exploration.