Latest Regulatory News

ReNerve has moved its NervAlign Nerve Guide Matrix into stage 3 of commercial development, a key step toward FDA submission and eventual market entry. This progress supports the company’s ambition to provide surgeons with an alternative to donor nerves for repairing severe peripheral nerve injuries.

Australian Unity Office Fund has secured Foreign Investment Review Board approval for the $40 million sale of its Brisbane office tower, setting the stage for a pivotal unitholder meeting to approve the sale, delisting, and wind-up of the fund.

Immutep Limited has won FDA Orphan Drug Designation for its immunotherapy eftilagimod alfa in treating soft tissue sarcoma, opening regulatory incentives and potential market exclusivity. This follows encouraging Phase II data despite recent Phase III trial setbacks.

Mesoblast has acquired exclusive rights to a patented chimeric antigen receptor platform designed to enhance the targeting and potency of its mesenchymal stromal cell therapies, aiming to expand treatment options for inflammatory and autoimmune diseases.

Riversgold Limited has reported standout assay results from 31 drill holes at its Northern Zone Gold Project, including a spectacular 71 g/t gold intercept. The campaign expands the shallow gold mineralisation footprint, supporting imminent mining lease conversion and a funding agreement with MEGA Resources.

WhiteHawk Limited has raised A$1.5 million through a share placement to fund integration and growth of its newly acquired Quixxi Clarity AI platform, marking a strategic push into the AI governance market.

Magnum Mining names Antonio Vitor Junior as Managing Director to spearhead major drilling campaigns at its Azimuth and Parker projects, aiming to convert promising early rare earth results into a formal resource.

Xenitra Limited has acquired Hong Kong Fukang Trading Co., including key pharmaceutical licenses and ecommerce assets, to fully operationalise its OTC medicine business in Hong Kong and China.

EV Resources has confirmed a large-scale, shallow carbonate replacement deposit (CRD) antimony system at its Los Lirios project in Mexico, with 10 of 11 drill holes intersecting the mineralised limestone unit. The system extends over a 400m strike and remains open in multiple directions, advancing the company towards a maiden JORC resource estimate.

Shine Justice reshuffles its top management as Simon Morrison steps down from Managing Director to Executive Director to spearhead international growth, particularly in its burgeoning mass torts program, while Carolyn Barker AM maintains overall CEO leadership.

Orthocell has secured approval for its Remplir™ nerve repair device to be used across 221 U.S. military and veterans hospitals, marking a major step in its U.S. commercial expansion. The approval follows clinical validation in conflict zones, positioning Orthocell to deepen penetration into defence healthcare.

AusQuest gears up for maiden drilling at two promising copper-gold prospects in Peru, aiming to build on the momentum from its Cangallo discovery. Over 8,000 metres of Reverse Circulation drilling are set to test high-priority IOCG and porphyry targets starting Q2 2026.