Latest Us Expansion News

Bubs Australia has secured permanent US FDA authorisation for three infant formula products, removing a regulatory barrier in the company’s largest market. The approval supports possible portfolio expansion and contract manufacturing, but the presentation contains no new earnings guidance or quantified financial benefit.

Emyria has secured a limited in-person speaking position at a US FDA hearing examining how psychedelic medicines could be delivered safely and at scale. The appearance gives the ASX-listed company a regulatory platform, but does not represent FDA approval, funding or a commercial agreement.

Immuron Limited has inked an exclusive US distribution deal for PROIBS®, a European-certified medical device targeting abdominal discomfort, marking a key step in its digestive health portfolio growth.

Great Northern Minerals (ASX: GNM) reported a $3.8 million loss for FY26 amid major US acquisitions, including the Iron Butte gold-silver project with a maiden resource of 480,000 oz gold and 11.5 million oz silver, and the Catalyst Ridge rare earths project. The company also completed a $2 million divestment of its remaining Golden Ant interest.

Titomic has raised A$16.5 million through an institutional placement priced at a 23.5% discount, aiming to scale its Huntsville facility and accelerate US growth. The company also advanced a US$10 million loan application with the Export-Import Bank and appointed aerospace veteran Jim Chilton to its board.

Vitrafy Life Sciences has secured its first US cell and gene therapy foothold by deploying its cryopreservation technology at Charter Medical's Innovation Hub, signalling a strategic expansion into a high-value biopharma segment.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

Adherium's FY2026 results show strong revenue gains from US remote patient monitoring but increased losses due to higher operating costs and commercial expansion.

Singular Health Group lifted revenues over fivefold to $1.43 million in FY26, driven by US commercial rollouts of its 3DICOM platform, but posted a $6.34 million loss. The company strengthened its US foothold with FDA clearance and a controlling stake in an associate.

Cobram Estate Olives (ASX:CBO) posted an 11.3% revenue increase to A$268.9 million in FY2026 but swung to a A$4.2 million net loss as costs surged and integration expenses weighed. The company declared a steady fully franked dividend of 4.5 cents per share.

Cyclopharm Limited posted a fifth consecutive record half-year revenue of $17.5 million, propelled by a 74% jump in US Technegas® sales and a doubling of revenue-generating US sites. New US clinical guidelines naming Technegas® as the preferred ventilation imaging agent underpin a robust growth outlook despite a wider net loss.

Zip Co Limited (ASX: ZIP) reported a 46% rise in net profit to $116.4 million for FY26, driven by strong US and ANZ market growth and record cash earnings of $268.9 million. The company also announced an orderly wind down of its New Zealand operations to focus on its core markets.