Latest Regulatory Filings News

Helios Energy Limited has come under ASX compliance scrutiny after late lodgement of director interest notices, raising questions about its disclosure practices and governance.

Dimerix has activated the first clinical trial site in Japan for its pivotal Phase 3 ACTION3 study targeting FSGS, triggering a significant milestone payment from its Japanese partner FUSO Pharmaceutical.

Neuren Pharmaceuticals posted record 2024 financials driven by DAYBUE royalties and advanced NNZ-2591 into Phase 3 trials, while launching a $50 million share buy-back amid volatile market sentiment.

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.

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.

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 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.

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.

Mayne Pharma Group has acknowledged a delayed filing of a director's interest notice due to administrative oversight and is taking steps to reinforce compliance with ASX disclosure rules.