Latest Regulatory News

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

Challenger Gold has secured the final Environmental Impact Assessment amendment for its Hualilán Gold Project, enabling ore haulage and toll milling at the Casposo plant. This milestone unlocks a low-capital pathway to early cash flow while advancing the project’s development.

Metal Bank Limited has announced a non-renounceable entitlement offer to raise approximately $2.32 million, partially underwritten, to fund its Western Australia gold strategy and Queensland graphite exploration. The offer closes on 31 October 2025 and coincides with a strategic acquisition of gold assets from Hastings Technology Metals.

First Lithium Limited has secured an $800,000 loan facility and received encouraging signals from the Mali government on license renewals for its key lithium projects, setting the stage for resource estimation and further development.

Power Minerals confirms a high-grade carbonatite hard rock intrusion at its Santa Anna Rare Earth Elements Project in Brazil, with promising grades and ongoing drilling aimed at defining a maiden resource estimate.

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

Syntara Limited has reported encouraging Phase 2a results for amsulostat combined with ruxolitinib in treating myelofibrosis, demonstrating sustained symptom improvement and spleen volume reduction over 52 weeks.

Aquirian Limited reports a 16.7% revenue increase alongside key operational advances at its Wubin facility and new leadership appointments, signaling strong momentum in mining services and technology.

TPC Consolidated and Wollar Solar Holding have agreed to extend key deadlines in their acquisition scheme as they await crucial FIRB approval, pushing the timeline into early 2026.

Bio-Gene Technology Limited has addressed ASX concerns over the timing of its announcement on promising Flavocide efficacy data, confirming compliance with continuous disclosure rules after receiving final presentation materials from Purdue University.

Australian Clinical Labs has reached a $6.2 million settlement with the Australian Information Commissioner to resolve a Federal Court case stemming from a 2022 cyberattack on its newly acquired Medlab Pathology business.

OncoSil Medical has affirmed the materiality of the PANCOSIL Phase 1-2 trial results and detailed its compliance with ASX disclosure rules following the data presentation at CIRSE 2025.