Latest Regulatory Milestones News

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.

Marvel Gold Limited has made significant progress in acquiring the Hanang Gold Project in Tanzania, submitting all regulatory documents and anticipating approvals soon. The company also prepares for its Annual General Meeting where shareholders will vote on a $2.5 million capital raising placement.

PolyNovo has secured Therapeutic Goods Administration clearance for thicker versions of its NovoSorb MTX product, broadening treatment options for complex wounds in Australia.

Black Rock Mining's subsidiary Faru Graphite Corporation has inked pivotal agreements with TANESCO to build a $40 million power line, connecting the Mahenge Graphite Project to Tanzania’s hydro-powered grid. This milestone enhances the project’s green credentials and de-risks its path to production.

Emperor Energy's Environmental Plan for the Judith-2 Well has passed NOPSEMA's completeness check and is now open for public comment, marking a key regulatory milestone on the path to drilling in mid-2026.

Orthocell has secured regulatory approval to sell its nerve repair product Remplir™ in Hong Kong well ahead of schedule, expanding its footprint across key global markets. This milestone complements recent clearances in the US, Canada, and Asia, positioning the company for significant growth in a multi-billion-dollar market.

Jameson Resources has released a comprehensive update on its Crown Mountain steelmaking coal project, revealing improved project economics and robust progress on environmental and Indigenous engagement fronts. The update underscores the project's strategic positioning amid tightening global supply and supportive government policies.

PEXA Group’s third-quarter results align with expectations, driven by Australian growth and UK market headwinds. The company reaffirms its FY25 guidance while navigating ongoing business assessments and regulatory milestones.