Latest Us Regulatory News

AdAlta has secured A$2.5 million in a strategic placement to push its lead CAR-T therapy BZDS1901 through critical US FDA regulatory steps and establish Australian manufacturing, building on promising clinical responses in advanced mesothelioma.

LTR Pharma highlights SPONTAN's 5x faster absorption and validated safety, backed by over 1,000 Australian prescriptions and strategic partnerships as it targets FDA approval and US market entry.

Volt Resources has secured a major extension and volume increase to its Bunyu graphite offtake agreement while progressing high purity graphite production and downstream refinery development in the US.

IDT Australia is poised for its strongest FY26 finish since its transformation began, forecasting a dramatic narrowing of EBITDA losses and revenue growth driven by strategic partnerships and operational upgrades.

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.

Resolution Minerals has raised A$20 million in a strongly supported institutional placement to accelerate exploration and development at its US Horse Heaven Project, while preparing for a NASDAQ listing to boost its US market presence.

Emyria has unveiled the Empax Global Partnership Program, a high-margin clinical delivery platform targeting international drug sponsors amid growing demand for psychedelic-assisted mental health treatments.

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.

Patrys has initiated manufacturing and regulatory steps for RLS-2201, its injectable Quetiapine formulation targeting delirium, aiming for Phase 0 trials in the second half of 2026.

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.

Island Pharmaceuticals reports a 213.8% increase in half-year loss to $4.81 million, driven by strategic acquisition and clinical development investments. The company advances its antiviral portfolio with Galidesivir and ISLA-101, supported by strong US regulatory engagement and a $9 million capital raise.

Viking Mines has completed due diligence on its Nevada tungsten portfolio, confirming high-grade mineralisation and fast-tracking acquisition and exploration to meet urgent US supply needs.