Latest Regulatory Submissions News

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.

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.

Neurizon Therapeutics has cleared a major regulatory hurdle with the FDA lifting the clinical hold on its lead drug NUZ-001 and secured a comprehensive $33 million funding package to advance its pivotal ALS trial.

Conrad Asia Energy and Empyrean Energy have reached a binding settlement over historical cash call arrears in the Duyung Production Sharing Contract, involving asset transfers and payments that realign project interests and support the Mako gas field’s development timeline.

Micro-X Ltd has secured a historic $3.3 million order for its Rover mobile X-ray units in Malaysia, alongside a $6.2 million capital raise to fuel its expanding medical imaging and security technology pipeline.

Nexsen Limited has reported significant progress in its rapid diagnostic technologies, including a key FDA pre-submission for its GBS rapid sensor and a solid cash reserve post-IPO to support commercialisation efforts.

Avecho Biotechnology is on the cusp of completing patient dosing in its pivotal Phase III CBD insomnia trial, backed by a recent $2.5 million capital raise and patent allowances in the US and Europe.

CurveBeam AI reported steady progress in Q2 FY26 with five new device purchase orders, a $4 million milestone payment pending receipt, and key regulatory submissions underway in the US and China.