Latest Regulatory Pathways News

AdAlta Limited has raised up to A$1.1 million through a private placement, boosting its war chest to advance innovative cellular immunotherapy projects targeting solid cancers.

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

Imricor Medical Systems has completed the world’s first Pulsed Field Ablation procedure under real-time MRI guidance, marking a breakthrough in cardiac ablation technology. This pre-clinical success validates their Vision-MR platform’s adaptability and sets the stage for safer, radiation-free heart treatments.

Ardea Resources has extended its Major Project Status for the Kalgoorlie Nickel Project, reinforcing its strategic role in Australia's critical minerals sector and ensuring continued government support.

TrivarX Limited has announced the acquisition of Stabl-Im, a novel stable isotope MRI technology for early brain tumor detection, backed by a $4.2 million capital raise including investment from biotech leader Dr Daniel Tillett.

Biotron Limited is set to acquire Sedarex Limited, gaining global patents for SedRx, a next-generation general anaesthetic, supported by a $2.5 million capital raising to fund regulatory and development milestones.

Artrya Limited has successfully navigated a key FDA Q-Submission meeting, receiving clear guidance on the regulatory pathway for its Salix Coronary Flow module, with a 510(k) submission planned by year-end.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent, progressing toward a Phase 2 clinical trial with strong collaborations and a recent AU$3.5 million capital raise.

Micro-X has completed its first Head CT test bench, marking a key milestone as it begins pivotal imaging trials in Australian hospitals to revolutionize stroke diagnosis.

Power Minerals confirms a high-grade carbonatite hard rock intrusion at its Santa Anna Rare Earth Elements Project in Brazil, with promising grades and ongoing drilling aimed at defining a maiden resource estimate.

Redcastle Resources and BML advance their strategic gold joint venture with key studies completed and mining proposal submission expected by late 2025, targeting initial production in early 2026.

Memphasys Limited is intensifying its commercial push for Felix, an innovative automated sperm separation system for IVF, backed by a landmark Middle East partnership and a fresh capital raise to scale manufacturing and sales.