Latest Regulatory Filings News

Prescient Therapeutics has secured FDA Fast Track designation for PTX-100 in treating relapsed Cutaneous T-Cell Lymphoma and dosed the first patient in its Phase 2a trial, supported by a recent $6.8 million capital raise.

Netlinkz Limited reported $979,000 in quarterly receipts and a landmark $1 million VSN license sale in the Philippines, while advancing significant cost reductions and debt restructuring efforts.

Actinogen Medical has reached a key milestone in its XanaMIA phase 2b/3 Alzheimer’s trial with over 100 participants enrolled, setting the stage for an interim analysis in January 2026. The company also secured a $13.8 million non-dilutive R&D funding facility to support ongoing development.

Avecho Biotechnology has ramped up recruitment in its pivotal Phase III insomnia trial and is advancing plans for regulatory approval and commercialization of its TPM®-enhanced CBD capsule, aiming to be the first over-the-counter CBD insomnia treatment in Australia.

Nexus Minerals has reported a significant new gold discovery at its Wallbrook Gold Project, highlighted by strong drilling results at the Payns Prospect, while progressing permitting for the Crusader-Templar deposit and maintaining a solid cash position.

Vonex Limited has taken a key step in its acquisition by Maxo Telecommunications, lodging a draft Scheme Booklet with ASIC that includes an independent expert’s report. This move brings the proposed takeover closer to shareholder approval and regulatory clearance.

Imagion Biosystems has made significant progress towards filing an Investigational New Drug application for its MagSense® HER2 breast cancer imaging agent, receiving encouraging feedback from the FDA and preparing for a Phase 2 clinical trial.

Domain Holdings Australia has received a draft class ruling from the ATO that aligns with its previously disclosed tax positions for the upcoming CoStar acquisition scheme. The final ruling, expected post-implementation, will provide definitive tax clarity for shareholders.

BPH Energy’s June quarter update highlights ongoing legal proceedings over the PEP-11 permit, promising progress in AI-driven brain monitoring technology, and strategic moves toward hydrogen production facilities, supported by a robust cash reserve.

Beam Communications reported a modest adjusted cash outflow in Q4 FY25 despite a 36% revenue drop due to delivery delays and sales transitions, while cost-cutting efforts continue to bolster its financial resilience.

Artrya has launched its AI-powered Salix Coronary Anatomy platform in the U.S. and submitted its Coronary Plaque module for FDA clearance, marking a key step in its commercial expansion. A new five-year contract with Tanner Health signals the start of U.S. revenues.

H&S Group has exercised performance options to increase its stake in Nuchev Limited to 48.62%, injecting $1.9 million and enhancing Nuchev’s financial flexibility for growth.