Latest Regulatory Filings News

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.

American Tungsten & Antimony Ltd is progressing its Nasdaq listing plans with a confidential SEC filing expected in March 2026 and has appointed Deutsche Bank as ADR depositary alongside a new CFO to support growth.

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.

Australian Dairy Nutritionals reported a 152% surge in nutritional powder sales despite regulatory hurdles in Vietnam, while expanding its Future brand footprint across China.

Australian Strategic Materials and Energy Fuels are set to discuss their proposed acquisition in a joint webcast, offering investors a closer look at this strategic move.

New Murchison Gold Limited reports a strong start at Crown Prince Gold Mine with 22,766 ounces produced and a robust $92 million cash balance, setting the stage for further growth in the Garden Gully Gold Project.

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.

Telix Pharmaceuticals has achieved a key milestone with China’s NMPA accepting its New Drug Application for Illuccix, a prostate cancer imaging agent backed by strong Phase 3 data. This paves the way for Telix to enter a rapidly growing Chinese market alongside its global approvals.

Rent.com.au has achieved a record quarterly revenue exceeding $1 million, driven by strong recurring income from its RentBond® and RentPay products. This milestone underscores the company’s evolving business model and solid financial footing.

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.