Latest Regulatory News

Acrux has locked in a milestone-based licensing agreement worth up to AUD 5.4 million for Lenzetto®, targeting the Australian menopause therapy market with regulatory and commercial milestones tied to TGA approval and sales performance.

Elanor Investors Group has called off its planned acquisition of Singapore-based Firmus Capital due to prolonged regulatory delays, while reaffirming its $125 million recapitalisation with Rockworth Capital Partners and seeking ASX trading reinstatement.

PolyNovo has completed its pivotal US clinical trial report for NovoSorb BTM and adjusted its FDA Premarket Approval submission timeline to late 2026 to incorporate updated regulatory requirements and additional data.

Dart Mining has acquired a vast tenement package in the mineral-rich Pine Creek Orogen, adding gold, copper, uranium, and tungsten prospects to its portfolio while raising A$1.3 million to fund exploration.

Arafura Rare Earths has successfully completed the first tranche of its A$350 million placement, issuing 675.1 million shares and raising approximately A$175.5 million before costs. The second tranche awaits shareholder approval.

4DMedical has landed a three-year commercial contract with SimonMed Imaging, deploying its CT:VQ™ technology across more than 170 US outpatient centres, marking a significant step in its US market expansion.

AnteoTech has locked in an underwriting deal to guarantee up to $7.5 million from the exercise of listed options, potentially raising as much as $10 million before costs.

Havilah Resources has locked in a $105 million upfront payment from Sandfire Resources for the Kalkaroo project and signed a binding farm-in agreement with Hillgrove Resources for Mutooroo, while gearing up for regional drilling in South Australia’s Curnamona Province.

Cuscal has finalised its purchase of New Zealand’s Paymark, aiming for earnings growth and a strong return on capital in the coming financial year.

Navigator Global Investments has wrapped up its $145 million entitlement offer, securing $4.1 million from retail investors despite modest participation, with the remainder allocated to sub-underwriters.

Elsight has secured a follow-on US$2 million order from a U.S. public safety customer, quadrupling its initial purchase and underscoring growing commercial traction ahead of expected FAA drone rule changes.

Bridge SaaS Limited (ASX: BGE) is issuing nearly 20 million Loyalty Options to reward shareholders, exercisable at $0.03 and expiring in 2031, aiming to bolster future capital without immediate dilution.