Latest Regulatory News

Orthocell has lodged a regulatory application to distribute its nerve repair product Remplir™ across the EU and UK, aiming to tap into a $750 million market with approval expected by Q3 2026.

Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.

Fortifai Limited has acquired an exclusive license to Nol8, a breakthrough real-time data processing technology developed by the Technion. This acquisition positions Fortifai to revolutionize data handling across gaming, AI, finance, and cybersecurity sectors.

Osmond Resources has reported strong assay results from its third drill hole at the Orión EU Critical Minerals Project, reinforcing the potential for a globally significant deposit of titanium, zirconium, and rare earth elements. The findings support ongoing development plans targeting EU supply chain needs.

Electro Optic Systems has inked a conditional US$80 million contract to supply a 100kW high energy laser weapon to a South Korean customer, marking its second major export order in this advanced defence technology.

Fortescue Ltd has announced a binding agreement to acquire the remaining 64% of Alta Copper, gaining full control of the Cañariaco Copper Project in Peru. The deal values Alta Copper at C$139 million and aligns with Fortescue’s expanding copper strategy.

Energy Resources of Australia has been granted a new rehabilitation authority to extend its environmental restoration work at the Ranger Project Area beyond January 2026.

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

Resolute Mining’s updated Definitive Feasibility Study for the Doropo Gold Project reveals a 55% increase in ore reserves, a longer mine life, and robust financial returns, positioning the project as a key growth driver.

Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.

Finder Energy has completed the acquisition of the Petrojarl I FPSO, gaining full control of vital infrastructure for the Kuda Tasi and Jahal project and setting the stage for a Final Investment Decision by mid-2026.

Echo IQ has formally lodged its FDA 510(k) submission for EchoSolv HF, an AI-driven heart failure diagnostic software validated by Mayo Clinic data, aiming to tap into a $60 billion US market.