Latest Regulatory News

PainChek Limited reported a 24% revenue increase to $4.8 million for FY25, narrowing its net loss by 7%, while progressing toward FDA clearance for its Adult PainChek App in the US and launching its Infant App in Australia.

Mesoblast reports a strong FY2025 financial performance driven by the commercial launch of Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. The company is advancing multiple clinical programs targeting inflammatory diseases, heart failure, and chronic low back pain.

Mesoblast Limited has reported its FY2025 results, highlighting the FDA approval and US commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, alongside a $102.1 million net loss and $161.6 million in cash reserves.

NobleOak Life Limited reported robust FY25 results, with a 20% increase in in-force premiums and a 22% rise in underlying NPAT, underpinned by strategic investments in AI and a transition to a capital-efficient Life Company structure.

NobleOak Life Limited reported a robust 20% growth in in-force premiums and a 22% rise in underlying profit for FY25, surpassing guidance and setting a clear path to $1 billion in-force premium. Strategic partnerships, acquisitions, and product innovation underpin its strong outlook for FY26.

NobleOak Life Limited reported a robust 22% increase in underlying net profit after tax for FY25, driven by strong premium growth and expanding market share. Despite a statutory profit dip due to one-off costs, the insurer plans to reinvest cash flows to fuel future growth and transition to a Life Company structure.

PEXA Group delivered a solid FY25 with 16% revenue growth and a 21% rise in EBITDA, while preparing for a UK platform launch backed by NatWest. Despite statutory losses from impairments, the company strengthened its balance sheet and outlined a confident FY26 outlook.

PEXA Group Ltd reported a robust FY25 with 16% revenue growth and a 21% rise in EBITDA, driven by national expansion and operational efficiencies. The company is advancing its UK platform launch backed by NatWest, while FY26 guidance signals continued growth and strategic focus on AI and resilience.

PEXA Group Limited reported a 16% revenue increase to $393.6 million for FY25, driven by growth across its Australian Exchange, UK International business, and Digital Solutions segments. Despite a statutory net loss of $76.1 million due to impairments and deferred tax derecognition, core EBITDA rose 21% with improved margins.

Evolution Energy Minerals has disclosed a default notice from Tanzanian regulators over delayed mining commencement, yet remains confident in retaining its key graphite mining license.

Sumitomo Corporation has committed to a strategic equity investment in Mitchell Services’ Loop Decarbonisation JV, valuing the business at $24 million and signaling confidence in its mining sector emissions solutions.

Change Financial Limited reported a robust FY25 with 42% revenue growth and its first full-year positive underlying EBITDA, driven by strong PaaS expansion and strategic exit from the US market. The company projects further growth and profitability in FY26.