Latest Regulatory Submissions News

Native Mineral Resources has successfully poured 1,543 ounces of gold doré at its Blackjack Processing Plant, while progressing key operational and regulatory initiatives to optimise mining and processing activities.

Patrys Limited has appointed Dr Samantha South as its new CEO, aiming to leverage her biotech expertise to fast-track clinical development and commercialisation of its therapeutic antibody pipeline.

Algorae Pharmaceuticals has secured a key Licence & Supply Agreement with Cadila Pharmaceuticals to commercialise two generic cardiovascular and metabolic medicines in Australia and New Zealand, broadening its therapeutic reach beyond oncology.

Memphasys has raised $800,000 through a share placement to accelerate the commercial expansion of its Felix™ System, following key regulatory approvals and initial revenue milestones.

OncoSil Medical Ltd has launched an $8 million equity raising to fund the commercial expansion and clinical development of its targeted radiotherapy device for pancreatic cancer, aiming to capitalise on growing European market adoption and upcoming trial catalysts.

OncoSil Medical secures $8 million in capital to fund a pivotal German government-sponsored clinical trial and accelerate its European commercial expansion.

Memphasys has lodged regulatory submissions for its Felix™ System in Australia and India, following CE Mark approval, while progressing UK market entry under the CE Mark transition framework.

Neurotech International has secured ethics approval to launch its Beyond Harmony Phase 3 clinical trial of NTI164 for autism spectrum disorder, marking a key step toward regulatory submissions in Australia and the US.

Tissue Repair’s December quarter update reveals a cautious path forward for its Phase 3 TR987 trial amid slow patient recruitment, while its TR Pro+ product line gains momentum through a new distributor partnership and upcoming product launches.

Resonance Health has reported record half-year revenue and strong progress in clinical trials, alongside promising new technology deployments set to enhance its global footprint.

Actinogen Medical’s pivotal XanaMIA trial for Alzheimer’s disease has received a green light from its independent Data Monitoring Committee to continue, reinforcing confidence in the drug’s safety and efficacy profile.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.