Latest Regulatory Approvals News

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.

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.

Wellard Limited reported a net profit of US$1.3 million for FY2025, driven by operational improvements and strategic asset sales. With the sale of its last livestock vessels completed, the company plans to delist from the ASX and return surplus cash to shareholders.

BlinkLab Limited reported a substantial net loss of $5.7 million for FY2025, driven by intensive R&D and clinical trial activities, while securing $7.66 million in fresh capital to fuel its smartphone-based neurodevelopmental diagnostic platform targeting autism and ADHD.

Cynata Therapeutics reported a $9.39 million net loss for FY2025, slightly improved from the prior year, while progressing multiple clinical trials with key results expected in 2026. The company maintains a solid cash position and funding runway through mid-2026, supported by recent capital raises and an equity subscription agreement.

Foresta Group Holdings reported a $3.375 million net loss for FY2025 while making significant progress on its Kawerau biomass facility in New Zealand, securing key approvals, partnerships, and funding. The company aims to commence construction in FY2026, positioning itself in the renewable energy sector.

NeuroScientific Biopharmaceuticals reported a $1.85 million loss for FY25, driven by reduced R&D incentives and increased development costs following its acquisition of StemSmart™ technology. The company is advancing clinical programs, including a Special Access Scheme for Crohn’s disease.

HPP has agreed to acquire Red Earth Energy Storage in a $40 million merger, aiming to relist on the ASX by early 2026 and capitalize on Australia’s growing battery storage market.

Argenica Therapeutics reported a 34% revenue increase driven by R&D incentives but saw losses widen by 31% due to intensified clinical trial activity. The company is progressing its ARG-007 Phase 2 stroke trial and engaging with the FDA to lift a clinical hold.

Mad Paws Holdings reported a $12.27 million loss for FY25, deepening from last year, as it divests its Pet Chemist business and agrees to a $62 million acquisition by Rover Group.

Clarity Pharmaceuticals reported a $64.3 million loss for FY2025 alongside significant clinical progress and a $203.6 million placement to fund its radiopharmaceutical pipeline expansion.

Reef Casino Trust and Iris Cairns Property Pty Ltd have agreed to increase the takeover bid price to $3.87 per unit, boosting the total offer value to approximately A$192.7 million. The unanimous board recommendation and major unitholder support underscore the deal’s momentum amid regulatory conditions.