Latest Regulatory News

Lumos Diagnostics has secured a key FDA 510(k) clearance with CLIA waiver for its FebriDx rapid test, unlocking a US$1 billion-plus market opportunity and triggering milestone payments exceeding US$6 million. The company reported a 37% revenue jump in Q3 FY26, supported by a A$20 million placement and ongoing clinical and development projects.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.

ASX has successfully deployed Release 1 of its CHESS system, introducing a modern clearing platform designed to handle increased trading volumes and improve resilience. The rollout marks a key step in ASX's technology modernisation strategy, with Release 2 on track for 2029.

Carnavale Resources has reinforced the high-grade nature of its Kookynie Gold Project with new drilling results, keeping its Bankable Feasibility Study on track for early Q3 2026 completion. The project’s robust economics and resource upgrades underpin growing investor interest.

Kinetiko Energy is advancing a staged development strategy to unlock its 6 trillion cubic feet gas resource in South Africa, targeting first revenues within 18 months through a capital-efficient, risk-managed approach.

Patrys has raised A$3.2 million through a share placement to fund its injectable quetiapine program’s Phase 1A clinical trial and FDA pre-IND preparations.

Critical Metals Corp has consolidated its stake in the Tanbreez Rare Earths Project, gaining government approval to increase ownership to 92.5%, while European Lithium retains a 7.5% interest. This clearance removes a key hurdle, enabling the project’s development to accelerate.

Emyria has unveiled the Empax Global Partnership Program, a high-margin clinical delivery platform targeting international drug sponsors amid growing demand for psychedelic-assisted mental health treatments.

Advanced Innergy Holdings has formalised its $0.40 per share offer to acquire Matrix Composites via a scheme of arrangement, aiming to expand its subsea manufacturing footprint across the Asia-Pacific region.

Orthocell’s Q1 FY26 revenue hits $3.2 million, buoyed by growing US sales of its Remplir nerve repair device and a robust $48 million cash position supporting global expansion.

Radiopharm Theranostics has reported encouraging initial results from the Phase 1 HEAT trial of its novel HER2-targeted radiopharmaceutical, 177Lu-RAD202, highlighting tumor uptake and a clean safety profile at the lowest dose with dose escalation approved.

BMC Minerals has kicked off its 2026 drilling campaign at the Kudz Ze Kayah Project with a standout massive sulphide intercept at the Krakatoa Zone, pointing to potential extensions beyond current reserves and a longer mine life.