Latest Regulatory Approval News

Bass Oil’s March quarter saw a 13% production dip due to Cooper Basin rains but secured key gas field acquisitions, a $3.5 million grant, and completed a $3 million capital raise.

Atomo Diagnostics capitalises on Lumos Diagnostics’ FebriDx FDA CLIA waiver with over $2 million in new sales orders and a $3 million capital raise, expanding its global footprint and product pipeline.

Rakon Limited has swung back to profit in FY26, reporting a 24% revenue lift and doubling EBITDA, while Bourns' takeover offer edges closer to completion with 85% shareholder acceptance and pending French regulatory approval.

Cazaly Resources has delivered promising high-grade gold assay results from its latest drilling at the Goongarrie Gold Project, extending mineralisation depth and strike length while initiating a new gravity survey to refine exploration targets.

Osmond Resources has released final assays from its Phase 1 drilling at the Orión EU Critical Minerals Project in Spain, revealing significant enrichment of titanium, zirconium, and rare earth elements over a 10km strike. The discovery of a new basal mineralised seam adds to the project's scale, with Phase 2 drilling imminent and a Scoping Study targeted for late 2026.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

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.

Cambium Bio has clinched FDA agreement on a streamlined single pivotal Phase 3 trial for Elate Ocular®, cutting development complexity, while bolstering its cash position through a A$2.4 million strategic placement by major shareholder ZYBT.

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.