Latest Regulatory Approvals News

Imugene Limited has reported compelling clinical trial results for its off-the-shelf CAR T therapy, azer-cel, alongside FDA validation and a strategic collaboration, while managing cash flow amid cost reductions.

Kingsland Minerals has completed a pivotal scoping study for its Leliyn Graphite Project, confirming high-grade purified spherical graphite production potential. The company also secured $2.16 million through a placement and share purchase plan and has commenced a pre-feasibility study.

Terragen Holdings reports a strong quarter with an 87% increase in sales of its ruminant probiotic and advances key livestock and crop trials, positioning itself for expanded market access.

AKORA Resources has completed a significant trenching program at its Bekisopa iron ore project in Madagascar and submitted a mining permit application under a revitalised regulatory framework, gaining strong government backing.

TerraCom Limited reported a stable operational quarter despite logistical challenges impacting coal shipments and cash flow, while successfully raising A$60 million to bolster liquidity. The Blair Athol mine life was extended to 2033, underpinning the company’s long-term outlook.

The Star Entertainment Group reported a 6% revenue increase to $301 million and a return to EBITDA profit in Q2 FY26, driven by stable Sydney trading, seasonal Gold Coast strength, and a key Brisbane operator fee. Strategic investments and refinancing efforts mark a pivotal phase for the company.

Evergold Minerals Limited advances its gold exploration with new tenement acquisitions and drilling approvals at key projects, while managing a tighter cash position heading into 2026.

Emerald Resources NL reported solid December quarter gold production from its Okvau Gold Mine and significant resource upgrades at its Dingo Range and Memot projects, underpinning its growth trajectory.

MRG Metals has expanded its rare earth portfolio through the acquisition of the high-grade Garies Rare Earth Project in South Africa, while also progressing key projects in Mozambique, signalling a diversified growth strategy in critical minerals.

Evion Group gains momentum as the US-Africa Strategic Infrastructure and Investment Working Group fosters trade, Madagascar accelerates mining permits, and Indian graphite operations deliver strong sales.

Beetaloo Energy has secured key regulatory approvals and approved the Final Investment Decision for its Carpentaria Pilot Project, setting the stage for first gas sales from EP187 in late 2026.

PainChek has achieved FDA regulatory clearance enabling its device to qualify for US Remote Therapeutic Monitoring reimbursement, positioning the company for significant growth in the expanding US healthcare market. The company also reports strong global licence growth and a solid pipeline across multiple regions.