Latest Regulatory Approval News

Tissue Repair Ltd reported a 27.3% revenue increase to $3.22 million for FY25, driven by new distribution deals and regulatory progress, while continuing to invest heavily in clinical trials and manufacturing scale-up, resulting in a $4.24 million loss.

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.

Resonance Health Limited reported a 29% revenue increase to $11.07 million for FY25 but posted a net loss of $1.73 million, reflecting strategic investments and expansion in clinical trial services.

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.

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.