Latest Us Market News

PainChek Ltd has secured FDA De Novo clearance for its Adult App, marking a pivotal entry into the US long-term care market and setting the stage for global expansion including its Infant App.

Proteomics International secures a key Medicare reimbursement rate for its PromarkerD test, a predictive diagnostic for diabetic kidney disease, marking a critical step in its US commercial rollout.

Select Harvests has reported a striking turnaround in FY2025, with net profit soaring to $31.8 million driven by higher almond prices and operational efficiency, while halving its net debt.

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.

Zelira Therapeutics has received a $1.07 million cash refund under Australia’s R&D Tax Incentive Scheme, reinforcing its funding for ongoing clinical trials and product development. The company has also repaid a prior loan advanced against this claim, positioning it for continued growth in cannabinoid-based medicines.

Clarity Pharmaceuticals has raised $203 million to accelerate its copper-64 and copper-67 radiopharmaceutical pipeline, targeting prostate and neuroendocrine cancers with multiple FDA Fast Track trials underway.

Acrux Ltd reported a remarkable surge in licensing revenue from its topical generics portfolio alongside a strategic pivot towards innovative drug delivery R&D at its 2025 Annual General Meeting.

Aroa Biosurgery has reported a strong first half for FY26, with 14% revenue growth driven by its Myriad product line and a return to positive EBITDA. The company also secured relief from ASX quarterly reporting requirements, signaling improved financial stability.

Pacific Edge reports a $19.1 million net loss for the first half of FY26 amid Medicare coverage loss but positions itself for a Medicare-led recovery with strong clinical evidence and a key advisory committee meeting set for February 2026.

DroneShield Limited reaffirms strong business fundamentals with record revenues in 2025, while addressing recent media reports and initiating an independent governance review.

Echo IQ has completed a pivotal clinical validation of its EchoSolv HF software at the Mayo Clinic, achieving outstanding accuracy ahead of its FDA submission. This milestone sets the stage for potential US market entry into a $60 billion heart failure diagnostics sector.

Lumos Diagnostics has achieved a major milestone by securing 100% Medicare reimbursement recognition for its FebriDx test across all seven US Medicare Administrative Contractors, paving the way for broader adoption in the American healthcare system.