Latest Regulatory Approval News

Infinity Mining Limited’s 2025 AGM highlighted significant portfolio reshaping, including asset sales and acquisitions, alongside promising exploration results at the Cangai Copper Project.

Prescient Therapeutics has completed a $3 million share placement, bolstering its clinical development programs for innovative cancer treatments including PTX-100 and novel cell therapies.

Alligator Energy Limited offers Placement Participants up to 278 million options exercisable at $0.047 each, following a $17.25 million placement completed in June 2025. The options offer closes on 8 September 2025 and is exclusive to Placement Participants.

Resonance Health reports robust FY25 results with 29% revenue growth and outlines ambitious FY26 guidance targeting $17 million in revenue and $2 million EBITDA. The company’s transformation into three profit-generating segments underpins its expanding footprint in the global clinical trial ecosystem.

Alterity Therapeutics reported a reduced net loss of A$12.15 million for FY2025, buoyed by positive Phase 2 clinical trial results for its lead drug ATH434 in Multiple System Atrophy and a successful A$40 million capital raising.

Bubs Australia Limited reports a striking turnaround in FY25 with revenue up 29% to $102.5 million and net profit soaring 124% to $5.17 million, driven by strong US and China growth. The company awaits permanent FDA approval, a pivotal factor for its future trajectory.

Atomo Diagnostics reported a 27% reduction in net loss to AUD 4.97 million for FY25, alongside a 7% revenue dip to AUD 3.79 million, driven by stronger margins and cost controls. The company also secured a significant US distribution contract through partner Lumos Diagnostics, positioning it for growth.

Immutep Limited reported a widened loss of A$61.4 million for FY2025, driven by increased R&D and clinical trial expenses, while progressing its lead immunotherapy candidate into a pivotal Phase III lung cancer trial. The company maintains a robust cash position supporting operations through 2026.

Mayne Pharma reported a 5% revenue increase to $408.1 million for FY25 but posted a net loss of $93.8 million, narrowing from the prior year. The company’s planned acquisition by Cosette Pharmaceuticals faces legal hurdles, delaying completion.

The Star Entertainment Group reported a challenging FY25 with a $471.5 million statutory net loss and a $77.1 million EBITDA loss before significant items, driven by regulatory reforms and market share declines. The group secured a $300 million strategic investment to support its turnaround efforts amid ongoing legal and licensing uncertainties.

The Star Entertainment Group reported a statutory net loss of $471.5 million for FY25, impacted by regulatory reforms and remediation costs, while securing a $300 million strategic investment to bolster liquidity.

Gladiator Resources has initiated the process to list on the US OTC Markets, aiming to enhance visibility and liquidity among North American investors as part of its rare earth elements growth strategy.