Latest Regulatory Milestones News

ioneer Ltd has raised approximately US$50.4 million through an institutional placement to fund the advancement of its Rhyolite Ridge lithium-boron project in Nevada towards a Final Investment Decision in the second half of 2026. The capital injection supports project readiness, environmental permitting, and early works for this strategically significant US critical minerals asset.

HeraMED has secured pivotal US commercial agreements and achieved a key Australian regulatory milestone, positioning itself for scalable growth in digital maternity care.

Latrobe Magnesium has resolved a critical manufacturing defect at its Demonstration Plant, enabling Magnesium Oxide production to resume, while securing key financial support for its commercial expansion plans.

Artrya Limited has converted three US foundation partners into commercial customers, generating its first fee-per-scan revenues, while progressing FDA clearance for its Salix Coronary Flow module and expanding its clinical study network.

QPM Energy has secured key contracts and financing milestones for its 112MW Isaac Power Station, while managing stable gas supply amid weak electricity prices.

Prescient Therapeutics has secured a key regulatory milestone with the EMA granting Orphan Drug Designation for PTX-100 to treat cutaneous T-cell lymphoma, while expanding its Phase 2a clinical trial across multiple continents.

Beetaloo Energy has secured key regulatory approvals and approved the Final Investment Decision for its Carpentaria Pilot Project, setting the stage for first gas sales from EP187 in late 2026.

PainChek has achieved FDA regulatory clearance enabling its device to qualify for US Remote Therapeutic Monitoring reimbursement, positioning the company for significant growth in the expanding US healthcare market. The company also reports strong global licence growth and a solid pipeline across multiple regions.

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.

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.

Taiton Resources has completed drilling at its Challenger West project and is preparing to drill at the Highway project's Yogi prospect, backed by a $2 million capital raise and a key board appointment.