Latest Regulatory Filings News

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.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in treating FSGS kidney disease has passed its sixth independent safety review with no concerns, reinforcing the drug’s promising safety profile.

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.

Avecho Biotechnology has expanded its pivotal Phase III clinical trial for a CBD insomnia treatment by adding new recruitment sites and partnering with pharmaceutical giant Sandoz to boost patient enrolment and regulatory progress.

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.

QBE Insurance Group has announced plans to issue AUD subordinated notes as part of its capital management strategy, aiming to strengthen its Tier 2 capital base. Details on pricing and timing will follow, contingent on market conditions.

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.

Anteris Technologies Global Corp. reported a $21.9 million net loss for Q1 2025, driven by increased R&D spending as it scales manufacturing and prepares pivotal trials for its DurAVR Transcatheter Heart Valve. The company’s recent $80 million IPO proceeds are being deployed to support these efforts and repay debt.

Mount Burgess Mining NL has voluntarily suspended trading of its shares on the ASX pending a court ruling on the validity of a recent cleansing notice tied to new share issuance.

Emperor Energy's Environmental Plan for the Judith-2 Well has passed NOPSEMA's completeness check and is now open for public comment, marking a key regulatory milestone on the path to drilling in mid-2026.

Orthocell has secured regulatory approval to sell its nerve repair product Remplir™ in Hong Kong well ahead of schedule, expanding its footprint across key global markets. This milestone complements recent clearances in the US, Canada, and Asia, positioning the company for significant growth in a multi-billion-dollar market.