Latest Regulatory Approval News

NH3 Clean Energy has completed critical environmental surveys for its WAH2 Project, confirming no threatened species or ecological communities in the development area. This milestone supports upcoming State and Commonwealth approval submissions, advancing the project towards its final investment decision.

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.

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.

Union Star Metals has agreed to sell its Brazilian rare earth subsidiary to Harvest Minerals, receiving cash, shares, and milestone payments while sharpening its focus on gold and silver exploration in the US.

SkyCity Entertainment Group has signed a non-binding heads of agreement to sell The Grand Hotel, aiming to boost financial flexibility through asset monetisation and debt repayment.

Ceretas Limited is raising $8 million through an IPO to fund clinical trials and development of its novel therapeutic ultrasound device targeting Alzheimer’s disease symptoms.

Recce Pharmaceuticals secured a non-binding term sheet with a major Middle Eastern pharma for its diabetic foot infection treatment and raised A$4 million to fund pivotal Phase 3 trials in Australia and Indonesia.

Silver Mines has confirmed robust economics for its Bowdens Silver Project, boosting ore reserves to 93.5 million ounces and outlining a 26-year mine life with a $455 million capital cost estimate.

AFT Pharmaceuticals has received tentative US FDA approval for its Scomara cream to treat Facial Angiofibromas in Tuberous Sclerosis, but US commercialisation is postponed until 2029 due to orphan drug exclusivity. The approval bolsters regulatory prospects in other key markets where AFT anticipates competitive advantages.

Havilah Resources has kicked off reverse circulation drilling at its Brooks Dam prospect near Kalkaroo, aiming to penetrate a stubborn gossan-chert horizon and better define underlying copper-gold mineralisation. The drilling is part of a strategic alliance with Sandfire Resources, which is also advancing its own large-scale drilling and prefeasibility work at Kalkaroo.

Energy Transition Minerals (ASX:ETM) has completed its purchase of the Penouta Tin-Tantalum-Niobium mine in Spain, advancing its ambition to become a key European critical minerals producer with plans to restart operations.