Latest Us Market News

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Resolution Minerals Ltd has entered a binding agreement to acquire the Horse Heaven Project in Idaho, a promising antimony-gold-silver-tungsten asset adjacent to a major US mine, with drilling planned for 2025.

Zip Co Limited has raised its FY25 cash EBTDA guidance to at least $160 million, driven by robust transaction growth in the US market exceeding 40% year-on-year in May 2025. The company also continues its share buy-back program amid steady credit performance.

Argenica Therapeutics faces a clinical hold from the US FDA on its stroke drug trial application, though its Australian Phase 2 study remains unaffected and on track.

Optiscan Imaging Ltd has launched InSpecta™, a cutting-edge microscopic imaging device tailored for veterinary medicine, marking its strategic entry into a booming $12 billion US market. The device promises to revolutionize diagnostics and treatment for companion animals with real-time, non-invasive imaging.

EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.

BetMakers Technology Group launches a $13.5 million equity raise to fund the acquisition of Las Vegas Dissemination Company and strengthen its financial position amid improving operational metrics.

BetMakers Technology Group has raised A$12.5 million through an institutional placement and plans a further A$1 million via a Share Purchase Plan, positioning itself for strategic expansion and debt repayment.

Proteomics International has completed a $12 million capital raise, including a heavily oversubscribed Share Purchase Plan, to fast-track the rollout of its innovative diagnostic tests in Australia and the USA.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.

QuickFee Limited has launched a A$1.5 million capital raising to fund expansion of its loan books in the US and Australia, following a quarter of record revenue and positive earnings before tax. The fintech also completed a major refinancing and revised its earnings guidance due to a credit impairment provision.