Latest Us Market Entry News

Starpharma has secured FDA alignment on the clinical development plan for its DEP® HER2 radiotherapy candidate, paving the way for a first-in-human phase 1 study in advanced HER2-positive cancers scheduled for H2 2026.

AnteoTech (ASX: ADO) pushed forward its advanced battery and life sciences technologies in the March 2026 quarter, achieving key product validations and expanding its sales pipeline to record levels. The company ended the period with A$3.3 million cash and no debt following a recent A$3.5 million capital raise.

Orthocell’s Q1 FY26 revenue hits $3.2 million, buoyed by growing US sales of its Remplir nerve repair device and a robust $48 million cash position supporting global expansion.

Omnia Metals has made a decisive entry into the US critical minerals market by acquiring the Stibnite Ridge antimony and silver project and staking the Radix rare earth and gallium project in Montana, backed by a $1.5 million capital raise.

PainChek has secured a landmark agreement with Sabra Health Care REIT to deploy its AI-powered pain assessment across up to 20,000 beds in North America, marking a pivotal step in its US expansion.

Harvest Technology Group has secured independent validation of its Nodestream platform's strong fit within the US defence sector, highlighting a clear pathway for market entry focused on bandwidth-constrained communications.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Imricor Medical Systems has submitted its NorthStar Mapping System for FDA pediatric label expansion, aiming to accelerate adoption in over 250 US children’s hospitals and broaden its commercial footprint.

Latrobe Magnesium has locked in a US$2 million non-dilutive prepayment from its US distribution partner to accelerate commissioning of its Demonstration Plant, aiming for first magnesium deliveries in late 2026.

Sultan Resources is advancing plans to list on the US OTC Markets Group, aiming to enhance liquidity and attract North American investors while pursuing strategic acquisitions.

LTR Pharma has finalised recruitment for its Phase II clinical trial of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, with initial results expected in the second quarter of 2026.

Thrive Tribe Technologies reported a $1.8 million half-year loss, driven by a major software impairment and ongoing operational challenges, while raising over $1.5 million in fresh capital to support its evolving business model.