Latest Regulatory Approvals News

Neurizon Therapeutics has secured FDA clearance for its lead drug candidate NUZ-001 to enter the HEALEY ALS Platform Trial, marking a key regulatory milestone and setting the stage for patient enrollment in early 2026.

Lunnon Metals reports significant high-grade gold assay results from the Lady Herial deposit, confirming promising mineralisation below and within the planned open pit. The company advances towards regulatory approvals and a final investment decision.

St Barbara Limited has locked in A$470 million in funding through strategic partnerships with Lingbao Gold Group and Kumul Mineral Holdings, fully financing the Simberi Gold Project expansion and accelerating its development timeline.

St Barbara Limited has agreed to sell a 20% interest in its Simberi Gold Project to Papua New Guinea’s Kumul Mineral Holdings for A$100 million, forming a strategic joint venture that aligns with PNG’s resource ownership goals.

St Barbara Limited’s latest Feasibility Study confirms the Simberi Expansion Project as a long-life, low-cost gold and silver operation with robust economics and a 13-year mine life. The project promises over 2 million ounces of gold production and competitive costs, pending key regulatory approvals.

Almonty Industries has priced an upsized US$112.5 million share offering to accelerate development of key tungsten and molybdenum projects, reinforcing its position amid tightening global supply chains.

Critical Metals Corp has partnered with Romania's state-owned FPCU in a 50/50 joint venture, securing half of the Tanbreez rare earth concentrate and boosting European supply chain security.

Medallion Metals and IGO Limited have agreed to extend the deadline for completing the Forrestania Nickel Operation acquisition, allowing more time to meet key conditions and secure environmental approvals.

Mayne Pharma has rejected Cosette Pharmaceuticals’ notice to terminate their merger agreement, citing Cosette’s failure to meet obligations that led to regulatory approval issues. The dispute raises fresh uncertainty over the proposed acquisition’s future.

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.

Ampol Limited reports solid first-half 2025 results, highlights a strengthening refinery margin, and advances its strategic acquisition of EG Australia, aiming to reshape its retail footprint and cost base.

Trigg Minerals has received tentative approval to begin diamond core drilling at its Antimony Canyon Project in Utah, focusing on high-grade stibnite mineralisation on private patented claims. Drilling is set to start before the end of December 2025, marking a key step from exploration to development.