Latest Regulatory Approval News

Neuren Pharmaceuticals has published promising Phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, underpinning its ongoing Phase 3 Koala trial recruiting in the US.

CurveBeam AI has received official Chinese regulatory approval for a strategic $10 million investment from WEGO Orthopaedics, marking a major step in its expansion into Greater China. The initial $4 million tranche at a premium share price is expected imminently, underpinning a decade-long commercialisation deal.

Manuka Resources is gearing up to recommence gold and silver production in the Cobar Basin by mid-2026 while awaiting a pivotal regulatory decision on its large-scale iron sands project in New Zealand.

American Tungsten & Antimony Ltd is set to submit a Notice of Intent for its first diamond drilling program at the Tennessee Mountain Tungsten Project in Nevada, aiming to validate historic high-grade mineralisation and establish a formal resource estimate.

Nexsen Limited has initiated FDA engagement for its rapid Group B Streptococcus diagnostic sensor, aiming for expedited US market entry, while bolstering its leadership team and scientific credentials.

AusQuest Limited has significantly extended the copper-gold mineralised system at its Cangallo project in Peru through recent diamond and RC drilling, revealing depths beyond 800 metres and strike length exceeding one kilometre.

Medallion Metals Limited has opened a Share Purchase Plan offering eligible shareholders in Australia and New Zealand the chance to buy shares at a 20.8% discount, aiming to raise $5 million for advancing its Forrestania and Cosmic Boy projects.

Temas Resources has fortified its position in the critical minerals sector through key strategic moves including joining Québec’s CSM Scientific Network, engaging market-making services, and commissioning independent equity research.

BlinkLab Limited has secured independent scientific validation for its smartphone-based autism diagnostic technology through publication in the prestigious journal Autism Research, marking a significant milestone ahead of its FDA regulatory trial.

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.

Iron Road has declined to extend Revera Energy’s option to purchase a strategic 24-hectare land parcel at Cape Hardy, marking a significant shift in their green hydrogen project partnership. Two larger land purchase options remain active, with potential buyback rights now triggered.

Triton Minerals has executed a pivotal Shareholders Cooperation Deed with NQM Gold 2 Pty Ltd, marking significant progress under their Share Sale and Purchase Agreement. This step sets the stage for governance arrangements ahead of project completion.