Latest Regulatory Filings News

Memphasys Limited has submitted its Felix™ sperm separation system for CE Mark approval, targeting Europe’s $5 billion IVF market, while expanding direct sales in Japan and validating its RoXsta™ oxidative stress diagnostic platform.

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.

Wingara AG has finalised the sale of its JC Tanloden machinery and reported a cash balance of $531,000 as of June 30, 2025, while the anticipated Terra Firma transaction remains unresolved.

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.

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.

Surefire Resources NL has responded to ASX inquiries concerning multiple breaches of its Securities Trading Policy by Executive Chairman Vladimir Nikolaenko, committing to enhanced compliance measures and policy revisions.