Latest Regulatory News

Entropy Neurodynamics has reported breakthrough Phase 2 clinical results for its intravenous psilocin therapy in treatment-resistant Binge Eating Disorder, alongside strong Phase 2a data in Irritable Bowel Syndrome and a new US patent filing.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

Polymetals Resources continues to confirm substantial high-grade silver-lead-zinc mineralisation at the Endeavor Mine's upper Main Lode, progressing towards a new Mineral Resource estimate.

Optiscan Imaging has kicked off a US clinical trial with Mayo Clinic to test its InVue and InForm devices in breast conserving surgery, aiming to generate data for FDA 510(k) submissions and validate a new surgical-pathology workflow.

Mitchell Services reported a robust FY26 with EBITDA up 67% and a net cash position of $3.5 million, driven by a shift towards gold projects and rising rig activity.

Ardea Resources is pushing forward its Kalgoorlie Nickel Project’s Goongarrie Hub with a fully funded $98.5 million Definitive Feasibility Study, underpinned by multi-jurisdictional government support and strategic partnerships with Japanese industry giants.

Radiopharm Theranostics reported robust Phase 2b results for RAD101 in brain metastases imaging, hitting 93% concordance with MRI and setting the stage for a U.S. Phase 3 trial. Meanwhile, its Phase 1 trial of RAD204 showed durable partial responses and good tolerability in advanced solid tumors.

Medallion Metals has signed a non-binding Term Sheet with TG Metals to process 60,000 tonnes of gold stockpiles at its Cosmic Boy Concentrator, sharing pre-tax profits equally after cost recovery. This deal complements Medallion’s Early Production Strategy and will not disrupt its Ravensthorpe project timeline.

Buru Energy pushes forward with its Rafael Gas Project development, securing A$5.3 million in funding and progressing environmental approvals while navigating executive leadership changes.

Coda Minerals has cleared a key regulatory hurdle for its Elizabeth Creek Copper-Silver Project with the formal gazettal of its Scoping Report, setting a clear pathway for mining lease approval and reducing project uncertainty.

PYC Therapeutics has secured Safety Review Committee approval to escalate dosing in its Phase 1b trial of PYC-003 for Polycystic Kidney Disease, alongside regulatory clearance for an Open-Label Extension allowing continuous dosing up to 24 months.

Antares Metals (ASX: AM5) has secured approval to begin heritage surveys and drilling at its Quinns VMS project in Western Australia, backed by $237,500 in government co-funding. The company aims to test high-grade extensions of the historic Austin deposit and untested regional prospects, with copper prices rising sharply since the last resource estimate.