Latest United States News

Bubs Australia delivered 9.2% revenue growth and a sharp underlying EBITDA improvement in FY26, but statutory losses, weaker margins and negative operating cash flow expose the cost of its expansion. Permanent US FDA authorisation removes a major regulatory hurdle, while the annual report still flags material uncertainty around ongoing funding and cash generation.

Clever Culture Systems has appointed PSC Biotech as its sole sales agent for APAS Independence across pharmaceutical manufacturing markets in the US, Canada and Singapore. The agreement expands CCS’s reach beyond its direct focus on major global drugmakers, but any material revenue uplift is not expected before FY28.

Talga has moved Talnode-C from qualification into commercial shipments, completed key engineering work for its staged Vittangi project and secured major Swedish permits. But the battery materials developer remains loss-making, cash-burning and reliant on further funding to continue development.

Volt Resources has secured a $1.5 million placement to fund its Alabama high-purity graphite refinery study, advance pilot work and reduce debt. Almost half the raise is subscribed by two directors, although their participation still requires shareholder approval.

Prescient Therapeutics has reached the first planned review threshold in its PTX-100 Phase 2a lymphoma study, while a completed A$6.0 million raise extends funding beyond the December milestone. The review will assess safety and efficacy, but is not a study completion or a new clinical result.

The US FDA has supported six of seven elements NeuroScientific Biopharmaceuticals put forward for its planned StemSmart Phase 2 Crohn’s disease trial. The remaining issue is a manufacturing control for viral contamination, while trial commencement remains targeted for the end of 2026 and subject to further requirements.

Orthocell says Remplir was placed successfully in five complex robotic prostatectomy cases, with no device-related complications reported over approximately 12 months. The preliminary results will guide a larger prospective trial ahead of a planned US expansion for the nerve repair product.

Ionic Rare Earths has moved its Belfast magnet recycling project closer to construction while expanding into the United States through a proposed US$100 million joint venture. The progress comes with key funding, approvals and definitive agreements still outstanding.

TZ Limited is still seeking funding after failing to complete its shortfall share placement, with $1.3 million in debt and vendor obligations due. The company says a management restructure, cost cuts and commercial opportunities could improve cash generation, but several forecasts remain conditional.

Medical Developments International returned to EBIT profitability in FY26 as Penthrox volumes strengthened across Australian hospitals and Europe. The company now faces the less glamorous test of converting regulatory progress into repeatable demand while absorbing weaker Respiratory sales and new amortisation costs.

Amaero has released A$2.961 million of restricted cash after renegotiating its EXIM loan, while its proposed US IPO moves through an amended SEC filing. Preliminary September figures show revenue of up to A$5.833 million, but operating cash use remained close to A$9 million.

Li-S Energy has signed an agreement to evaluate its Australian-made lithium-sulfur batteries in Safesky Systems' tactical drone platforms. The collaboration opens a potential defence supply pathway, but commercial orders remain dependent on testing and customer procurement decisions.