Latest Regulatory Filings News

Memphasys has lodged regulatory submissions for its Felix™ System in Australia and India, following CE Mark approval, while progressing UK market entry under the CE Mark transition framework.

Askari Metals has addressed an ASX query regarding the late filing of a director's securities interest notice, attributing the delay to awaiting regulatory guidance following an inadvertent related party securities breach.

Hydrix Limited has amended its quarterly cash flow report, revealing stronger customer receipts and a stable cash position supported by robust financing facilities.

Neurotech International has secured ethics approval to launch its Beyond Harmony Phase 3 clinical trial of NTI164 for autism spectrum disorder, marking a key step toward regulatory submissions in Australia and the US.

Imagion Biosystems has submitted its Investigational New Drug application to the U.S. FDA for its MagSense® HER2 Imaging Agent, marking a pivotal step toward launching a Phase 2 clinical trial for breast cancer detection.

Thrive Tribe Technologies reported a $186,000 net operating cash outflow in Q2 FY26, offset by a $300,000 equity raise to fund growth initiatives and operational expansion.

Hydrix Limited reported $2.3 million in revenue for Q2 FY26 and secured a $2.5 million initial contract with SynCardia Systems to develop a fully implantable artificial heart, setting a positive tone for 2026.

5E Advanced Materials has filed a Post-Effective Amendment to its SEC registration, updating the legal opinion on its planned issuance of up to 18 million shares. This move clears a key regulatory step in the company’s capital raising journey.

5E Advanced Materials has filed an SEC amendment to increase its public offering by $6 million, signalling a strategic move to bolster its capital base.

Tissue Repair’s December quarter update reveals a cautious path forward for its Phase 3 TR987 trial amid slow patient recruitment, while its TR Pro+ product line gains momentum through a new distributor partnership and upcoming product launches.

Resonance Health has reported record half-year revenue and strong progress in clinical trials, alongside promising new technology deployments set to enhance its global footprint.

Actinogen Medical’s pivotal XanaMIA trial for Alzheimer’s disease has received a green light from its independent Data Monitoring Committee to continue, reinforcing confidence in the drug’s safety and efficacy profile.