Latest Regulatory Milestones News

Janus Electric Holdings Limited will have its trading suspension lifted and resume quotation on the ASX from 21 May 2025 after meeting key listing requirements.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

Southern Palladium has secured Environmental Authorisation for its Bengwenyama PGM Project, a crucial step toward mining rights and project development. The company is also refining a phased, lower-capital approach to unlock value and improve financeability.

Arizona Lithium has achieved a landmark regulatory approval for Phase 1 production at its Prairie Lithium Project, marking the first lithium brine operation sanctioned in Saskatchewan. Updated drilling and modeling have significantly expanded the project's resource base and production potential.

Manuka Resources’ Taranaki VTM Project has cleared a key regulatory hurdle, moving forward in New Zealand’s Fast-track Approvals Process with promising economic and environmental prospects.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.

Anson Resources has gained regulatory approval to re-enter a historic well at its Green River Lithium Project, aiming to deepen the reservoir and advance its lithium resource definition. This move sets the stage for a critical feasibility study that could underpin future lithium production.

Paradigm Biopharmaceuticals has secured centralised US ethics approval for its pivotal Phase 3 trial of injectable pentosan polysulfate sodium (iPPS) targeting moderate to severe knee osteoarthritis, setting the stage for patient enrolment in Q3 2025.

Estrella Resources has upgraded four reconnaissance permits to exploration licenses in Timor-Leste, significantly enlarging its landholding and enabling advanced exploration activities targeting manganese and limestone deposits.

Carbine Resources has been granted a long-term mining lease for its Muchea Silica Sand Project, marking a significant step forward while awaiting further regulatory approvals.

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.