Latest Regulatory News

CLINUVEL Pharmaceuticals has received final scientific advice from the European Medicines Agency on the design of its pivotal Phase III trial for SCENESSE in vitiligo, endorsing a comprehensive evidence approach and prioritising patients with darker skin tones.

Macallum New Energy has successfully listed on the ASX and raised A$7.4 million to fund exploration in the Northern Perth Basin. The company is progressing a 66% complete Barberton 3D seismic survey and preparing a Condor 2D survey, positioning itself amid renewed regional drilling activity.

Kinetiko Energy has unveiled a staged gas production strategy in South Africa, aiming for initial compressed natural gas revenues by Q2/Q3 2027. The company’s new Rolling Cluster Development Strategy promises a risk-managed, capital-efficient pathway from early CNG production to full-field LNG.

Equatorial Resources has completed its final arbitration submissions against the Republic of Congo with a final ICSID award expected in the first half of 2027. Meanwhile, the company continues to seek clarity on the status of its iron ore exploration permits in Guinea amid ongoing regulatory uncertainty.

Temas Resources has closed a CAD 1.5 million flow-through share placement with Maple Leaf Critical Minerals Fund, reinforcing funding for its Quebec titanium projects and proprietary Regenerative Chloride Leach technology commercialisation.

St Barbara has given the final investment nod to restart its Touquoy gold operation in Nova Scotia, signing major local contracts and aiming to resume ore processing by the end of 2026.

Meeka Metals has secured a strategic 71km2 package of gold tenements around Mt Holland, aiming to unlock further ounces with a 20,000m drilling campaign over the next 12-18 months.

iTech Minerals is gearing up for a major drilling campaign at its Northern Territory gold-antimony project, while its South Australian graphite asset shows promising metallurgical progress towards battery-grade products.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

Tlou Energy has crossed a significant threshold by generating initial revenue from its Lesedi coal bed methane gas through the newly operational Kala Data Centre in Botswana. The milestone validates its integrated gas-to-power model while funding constraints and technical challenges remain key hurdles.

Eagers Automotive delivered a record $13 billion revenue in 2025, boosted market share in new and New Energy Vehicles, and secured landmark global partnerships to fuel future growth.

Cuscal has secured the final regulatory approval from the French Works Council, paving the way to complete its $27 million acquisition of New Zealand payments provider Paymark by late May.