Latest Regulatory Filings News

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Telix Pharmaceuticals showcased its global theranostic radiopharmaceutical portfolio, highlighting FDA approvals, clinical progress, and a robust commercial expansion plan at its 2025 Investor Day.

Vinyl Group Ltd has had its trading suspension lifted following a Federal Court decision related to its previous non-compliance with cleansing notice requirements.

Platinum Capital Limited has taken a significant step towards restructuring by lodging a draft scheme booklet to convert shareholder investments into an active ETF, aiming to resolve its persistent discount to net tangible assets.

Vinyl Group has applied to the Federal Court for an extension to lodge delayed cleansing notices, aiming to lift its ASX trading suspension. The court hearing is set for 5 June 2025, with market watchers awaiting the outcome.

Chorus Limited’s 2024 fibre regulatory report reveals a stable $5.9 billion asset base and revenue close to the maximum allowed, with a $153.5 million wash-up balance carried forward.

4DMedical has submitted its CT:VQ™ software to the FDA, aiming to revolutionize lung ventilation and perfusion imaging by replacing traditional nuclear scans with a non-contrast CT-based solution.

Neuren Pharmaceuticals has approved a significant long-term equity incentive plan tied to critical clinical and regulatory milestones for its drug candidate NNZ-2591, reinforcing management’s commitment to shareholder value.

James Hardie has released its financial results for the fourth quarter and full year ended March 31, 2025, accompanied by a suite of detailed reports filed with both the ASX and SEC.

Mayne Pharma has sent out the Scheme Booklet to shareholders, marking a key step in the proposed acquisition by Cosette. The booklet includes critical details to guide shareholder decisions ahead of the upcoming Scheme Meeting.

Alice Queen Limited is set to raise nearly $1 million through a two-tranche share placement, with substantial shareholder support and options attached, aiming to fuel exploration at its Viani project.

Anteris Technologies has submitted its FDA Investigational Device Exemption for the pivotal PARADIGM Trial of its DurAVR heart valve and marked a milestone of 100 patients treated, while expanding manufacturing capacity amid rising R&D costs.