Latest Regulatory Submissions News

Tetratherix Limited (ASX, TTX) reports significant progress in clinical trials, strategic partnerships, and manufacturing capacity, positioning itself for near-term commercialisation and sustained innovation.

EMVision Medical Devices reports strong progress in its emu™ Brain Scanner clinical trials, expanding recruitment across seven leading stroke hospitals and introducing new software features to enhance scan quality.

Echo IQ has completed clinical validation of its EchoSolv HF heart failure detection software with the Mayo Clinic Platform, achieving outstanding accuracy. The company has now formally submitted its FDA 510(k) clearance application, positioning itself for significant commercial expansion in the US healthcare market.

PYC Therapeutics has reported significant progress across its four RNA therapeutic programs targeting rare genetic diseases, supported by a strong cash position of $121 million at the end of 2025. Key clinical milestones and regulatory plans set the stage for upcoming trial readouts and potential market entry.

Viking Mines has secured a comprehensive historical dataset for its Linka tungsten project in Nevada, significantly cutting exploration time and costs. This strategic acquisition lays the groundwork for rapid 3D geological modelling and targeted drilling.

LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.

Wia Gold advances its Kokoseb Gold Project with a Definitive Feasibility Study on track for completion in late 2026, supported by strong drilling results and strategic divestment of Côte d’Ivoire assets. Leadership changes signal a new phase for the company.

Orthocell Limited has reported a record $3.2 million revenue for the December 2025 quarter, marking its seventh consecutive quarter of growth, fuelled by expanding sales of its nerve repair product Remplir in the US and other international markets.

Argent BioPharma has signed a binding agreement to acquire AusCann’s 48% stake in CannPal, enhancing its clinical and intellectual property assets for CannEpil®. The deal includes an option for the Neuvis® drug-delivery platform and aligns with Argent’s U.S. dual-listing ambitions.

NeuroScientific Biopharmaceuticals reports encouraging clinical responses in fistulising Crohn’s disease patients treated under Australia’s Special Access Scheme, setting the stage for pivotal Phase 2 trials later this year.

ReNerve Limited has secured broader regulatory approval in Hong Kong for its NervAlign® Nerve Cuff, enabling access to both public and private hospitals and validating the device’s clinical benefits through independent review.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its Vision-MR Diagnostic Catheter, paving the way for commercial sales in the US electrophysiology market.