Latest Regulatory Affairs News

Energy Fuels Inc. reported a transformative 2024 with a major acquisition boosting its heavy mineral sands assets, a uranium production ramp-up at key US mines, and commercial rare earth oxide output from its White Mesa Mill.

Cryosite Limited delivered robust FY26 results with revenue up 18% to $16.7 million and net profit rising 19%, underpinned by a strategic warehouse acquisition that doubled storage capacity and a cool room expansion.

Radiopharm Theranostics is gearing up for a pivotal Phase 3 trial of its brain metastases imaging agent RAD101, following strong Phase 2b results and an upcoming FDA meeting to finalise trial design.

Dimerix has secured full sponsorship of the US Investigational New Drug application for its Phase 2-ready kidney drug DMX-652, setting the stage for a clinical trial targeting acute kidney injury in late 2026.

Archer Materials has pinpointed a capillary blood collection method that matches venous samples in haemolysis levels, advancing its potassium Biosensor development towards integrated clinical testing.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

Acrux Limited spotlighted its Female Testosterone Metered Dose Transdermal System (MDTS) at the Bioshares Biotech Summit, revealing positive Phase II data and outlining a clear regulatory and commercial roadmap targeting Hypoactive Sexual Desire Disorder (HSDD) in women.

AdAlta’s lead CAR-T therapy EW-001 has achieved a rare clinical milestone with one mesothelioma patient remaining cancer-free two years after treatment, and a second reaching one-year survival, underscoring the therapy’s potential durability in a notoriously difficult cancer.

Neurotech International has secured $4.5 million through a share placement to fund its pivotal Phase III clinical trial of NTI164 for Autism Spectrum Disorder, aiming to reach topline data readout.

Northern Minerals propels its Browns Range Heavy Rare Earths Project forward with a planned Final Investment Decision in Q3 2026 and a significant 40% increase in the Dazzler Deposit resource.

Acrux Limited’s FY26 receipts soared 960% to $5 million, fuelled by licensing milestones and growing generic sales, while FDA guidance clears the way for pivotal Phase III trials of its Female Testosterone therapy.

Rua Gold’s Auld Creek Project has qualified for New Zealand’s new Fast-Track Approvals Act 2024, promising a faster permitting timeline and reduced regulatory risk as the company advances toward mine development.