Latest Regulatory Clearance News

Zeus Resources has made significant progress in its December quarter activities, advancing trenching at the Casablanca Antimony Project and confirming gold and lithium anomalies at Blue Hill. The company also reported stable cash reserves and key corporate developments following its 2025 AGM.

ReNerve Limited reported a robust 80% increase in quarterly sales driven by strong US market adoption and expanded hospital approvals. The company advances its nerve repair product pipeline with key regulatory milestones and a refreshed board.

PainChek has achieved FDA regulatory clearance enabling its device to qualify for US Remote Therapeutic Monitoring reimbursement, positioning the company for significant growth in the expanding US healthcare market. The company also reports strong global licence growth and a solid pipeline across multiple regions.

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.

Medical Developments International has posted positive operating cashflow for the first half of FY26, driven by robust growth in its flagship product Penthrox across Australia and Europe, alongside progress in paediatric approvals.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its NorthStar Mapping System, the first MRI-native 3D cardiac mapping platform approved in the US. This approval positions Imricor at the forefront of MRI-guided cardiac procedures in the world’s largest electrophysiology market.

Radiopharm Theranostics has reported promising interim results from its Phase 2b trial of RAD 101, showing high concordance with MRI in brain metastases patients, while progressing multiple other clinical programs and securing a strong cash position to fund operations into 2027.

EMVision Medical Devices reports strong clinical trial progress for its portable brain scanners, backed by solid cash reserves and milestone grant funding.

Energy Fuels Inc. has announced a proposed acquisition of Australian Strategic Materials (ASM) valued at approximately A$447 million, aiming to establish a leading Western rare earths and critical minerals producer with a fully integrated supply chain.

Fatfish Group Limited has refinanced its $5.67 million debt with Arena Investors LP and secured an additional $0.15 million through new convertible notes, including a board nomination right for Arena.

BlueScope Steel has received a $30 per share takeover proposal from a consortium of SGH Limited and US-based Steel Dynamics, sparking fresh speculation about the steelmaker's future.

Memphasys has secured CE Mark approval for its Felix™ sperm selection system, enabling full commercial rollout across Europe and activating multi-year contracts worth over A$1.3 million. This milestone signals the company’s transition into a revenue-scaling phase with global growth ambitions.