Latest Regulatory Process News

Metal Bank is pushing towards near-term gold production in Western Australia and expanding its critical minerals footprint in Queensland, backed by new processing partnerships and exploration milestones.

Acrux pivots from generics to developing a Female Testosterone therapy for HSDD, leveraging FDA feedback and a strong US market opportunity.

Whitehaven Coal’s March quarter production fell 14% due to seasonal wet weather in Queensland, but coal prices rose sharply and refinancing cut interest costs by up to A$55 million annually.

Elevate Uranium Ltd pushes back its U-pgradeTM pilot plant results to August 2026 amid operational tweaks, while reporting a doubled resource grade at Marenica and a 76.2 Mlb uranium resource at Koppies.

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.

Rokeby Resources (ASX:RKB) has secured the Omeo Gold Project in Victoria, adding a historical resource of 320,000 ounces at 4.0 g/t Au and launching a $4 million capital raise. The acquisition ushers in leadership changes and sets a clear path for resource expansion.

Horizon Oil has crossed the crucial 50.1% acceptance threshold in its off-market bid for Cue Energy, removing a key condition from the offer. Meanwhile, the Mereenie joint venture suspends planned drilling after gas sales talks with Northern Territory’s Power and Water Corporation expire.

Silver Mines has delivered promising exploration results from its Calico North and Kramer Hills projects in California, with standout silver and barite assays supporting imminent drilling campaigns.

Ardea Resources’ Kalgoorlie Nickel Project has been selected for the Australian Government’s Investor Front Door pilot, providing enhanced regulatory support and access to government financing to advance the project’s development.

Algorae Pharmaceuticals has reached a key regulatory milestone as the TGA accepts its initial registration dossier, paving the way for potential commercialisation of its generic medicines in Australia and New Zealand.

NH3 Clean Energy has entered a pivotal phase in its WAH2 Project development, partnering with global engineering giant Linde and progressing funding discussions to secure up to A$567 million. This collaboration aims to reduce capital and operational risks as the project moves closer to a final investment decision.

PEXA Group has dismissed any undisclosed information behind its recent share price drop, attributing market moves to a preliminary IPART pricing consultation paper.