Latest Regulatory Milestones News

PEXA has achieved a crucial regulatory milestone with FCA approval to operate as an Authorised Payment Institution in the UK, paving the way for its Sale & Purchase product launch later this year.

European Lithium Limited reports a maiden 45 million tonne rare earth resource at its Greenland Tanbreez Project, alongside a $24.5 million capital raise by its majority-owned Critical Metals Corp, underpinning its global lithium and rare earth ambitions.

Actinogen Medical advances its XanaMIA phase 2b/3 Alzheimer’s trial with faster patient enrolment and expands clinical sites, while achieving a pivotal FDA meeting outcome for its depression program. The company maintains a strong cash position, supporting ongoing development and commercialization efforts.

Australian Vanadium Limited reports significant progress across its vertically integrated vanadium strategy, with key project milestones, government approvals, and promising energy storage developments positioning it for growth.

Imugene Limited reports encouraging Phase 1b results for azer-cel in lymphoma, secures FDA Fast Track status, and strengthens patent portfolio while raising A$20 million to fuel ongoing immuno-oncology programs.

PainChek Limited reports strong progress toward FDA De Novo clearance for US market entry, launches its Infant App in Australia, and achieves robust global licence growth with a 30% year-on-year revenue increase.

Ecofibre Limited reported a $2.2 million operating cash outflow in 3Q25 with total cash at $1.3 million, highlighting mixed progress across its business units and a pressing need to monetise assets to sustain operations.

Battery Minerals Ltd has launched comprehensive geophysical and geochemical programs at its El Aguila Gold-Silver Project in Argentina, setting the stage for maiden drilling in Q3 2025 pending approvals.

Predictive Discovery Limited has reported robust drilling results at its Bankan Gold Project in Guinea, alongside key environmental approvals and a strategic A$69 million capital raise, positioning the company for accelerated development.

Titanium Sands Limited has secured the Terms of Reference for the Environmental Impact Assessment of its Mannar Heavy Mineral Project, marking a pivotal regulatory milestone. The company is also progressing tenure retention applications amid plans for further capital raising.

Bio-Gene Technology Limited has been awarded two significant grants totaling A$3 million by the US Department of Defense, validating its innovative insecticide technologies Flavocide® and Qcide®. The company is advancing regulatory filings and scaling production to target both military and civilian markets.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.