Latest Regulatory Approvals News

Dimerix’s blinded review of its pivotal ACTION3 Phase 3 trial confirms over 90% statistical power to detect DMX-200’s effect on proteinuria, reinforcing the study’s design and regulatory pathway.

VBX Limited has more than doubled the Measured and Indicated Mineral Resource at its Wuudagu bauxite project to 131.9 million tonnes with improved grades, while also enhancing its Definitive Feasibility Study scope and securing additional funding.

PYC Therapeutics fortified its balance sheet by $600 million and progressed key RNA therapeutic trials in Q1 2026, setting the stage for pivotal clinical data and regulatory submissions.

Orthocell’s latest Remplir™ Real World Evidence study reveals an 89.7% treatment success rate across 78 nerve repair procedures, reinforcing its clinical strength and fueling US and European market growth plans.

St George Mining has expanded its Araxá rare earths-niobium resource by 75% to 70.91Mt at 4.06% TREO, positioning the project among the world’s largest carbonatite deposits. The company also acquired land for processing facilities and forged new downstream partnerships, supported by Minas Gerais state tax incentives.

Algorae Pharmaceuticals has struck an exclusive commercial and licensing agreement with global pharma Zydus Lifesciences to bring 10 injectable, oral, and specialty medicines to Australia and New Zealand, pending regulatory approvals.

NH3 Clean Energy has marked strong progress in its WAH2 clean ammonia project by appointing Linde Engineering for FEED and securing a 15-year water supply agreement, setting the stage for a final investment decision by year-end.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.

TMK Energy’s Gurvantes XXXV project hit a new daily gas production record exceeding 1,350 m³, confirming commercial desorption. The company secured $6 million in funding and regulatory approval to drill three new pilot wells and advance domestic gas use in Mongolia.

Jade Gas Holdings has secured Mongolian regulator approval for its TTCBM Project appraisal report, paving the way for reserve booking and submission of a development plan toward Mongolia's first significant gas operation.

Miramar Resources has completed a 19-hole RC drilling program at its Gidji JV Gold Project, revealing extensive shallow gold mineralisation including high-grade hits. The company also progressed project sales and acquisitions, supported by a $1.49 million capital raise and board reshuffle.

Ardiden Limited has secured the historic Golden Patricia Gold Mine from Barrick, consolidating a high-grade gold corridor in Ontario’s Pickle Lake district and opening significant exploration opportunities.