Latest Regulatory Milestones News

Arovella Therapeutics has filed an IND application for its lead CAR-iNKT therapy ALA-101, selected a CRO for its upcoming phase 1 trial, and secured $19.4 million in cash to fund clinical progress and pipeline expansion.

Prodigy Gold NL reported significant gold intercepts from its Tanami North Project, alongside environmental baseline studies and a new 3D structural collaboration with CSIRO, positioning the company for future mining development.

Memphasys Limited has achieved its first material revenues following CE Mark approval for its Felix™ System, activating multi-year contracts across Europe, the Middle East, and Asia. The company is now transitioning from regulatory preparation to global commercial rollout with a focus on recurring revenues.

Imricor Medical Systems has secured Virginia Commonwealth University Health as the third US site for its VISABL-AFL clinical trial, advancing its FDA approval pathway for MRI-guided cardiac ablation technology.

Audeara Ltd reported a strong Q2 FY26 with revenues up 274% year-on-year, securing key regulatory approval in China and expanding its global licensing footprint.

VHM Limited has made significant strides in developing its Goschen Rare Earths and Mineral Sands Project, securing substantial funding and critical regulatory approvals while expanding its resource base.

Bayan Mining reports significantly enhanced rare earth element grades from follow-up surface sampling at its Desert Star Project in California, paving the way for drilling approval and further exploration.

Atomo Diagnostics has locked in exclusive global rights to a novel liver function test that rapidly detects liver injury, expanding its footprint in point-of-care diagnostics. The test, delivered on Atomo’s Pascal platform, targets drug-induced liver injury and chronic liver conditions with significant commercial potential.

BHP has reported a robust operational half-year, setting new production records and raising its copper output forecast for FY26 amid strong commodity prices.

Telix Pharmaceuticals has achieved a key milestone with China’s NMPA accepting its New Drug Application for Illuccix, a prostate cancer imaging agent backed by strong Phase 3 data. This paves the way for Telix to enter a rapidly growing Chinese market alongside its global approvals.

Riversgold Limited reports encouraging shallow gold intersections at its Northern Zone Gold Project near Kalgoorlie, supported by a $2.15 million capital raise with MEGA Resources as a key investor. The drilling results and strategic partnership set the stage for advancing mining plans in 2026.

Southern Cross Gold Consolidated Ltd. has achieved a pivotal regulatory milestone enabling underground exploration at its Sunday Creek project, backed by strong drilling results and a robust cash position of $130.4 million.