Latest Regulatory Filings News

OncoSil Medical secures $8 million in capital to fund a pivotal German government-sponsored clinical trial and accelerate its European commercial expansion.

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.

A handful of healthcare names did the heavy lifting this week, driven by FDA wins, guideline upgrades, and big shifts in sales and cashflow. The flip side: several clinical-stage stocks fell hard as investors stayed picky about near-term proof and funding.

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.

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.

Optiscan Imaging Ltd has made significant strides in clinical studies and regulatory readiness, partnering with Australian Clinical Labs and launching new cancer imaging trials as it prepares for multiple FDA submissions in 2026.