Latest Regulatory News

ReNerve Limited has secured broader regulatory approval in Hong Kong for its NervAlign® Nerve Cuff, enabling access to both public and private hospitals and validating the device’s clinical benefits through independent review.

Clinuvel Pharmaceuticals has initiated dosing in a preclinical study of its novel controlled-release injectable peptide platform, VLRX-L, aiming to enhance drug delivery for melanocortin-based therapies. Preliminary results are expected in the second half of 2026.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its Vision-MR Diagnostic Catheter, paving the way for commercial sales in the US electrophysiology market.

Haranga Resources has confirmed a significant continuous gold mineralised trend exceeding 800 metres at its Ibel South Gold Project in Senegal, with plans for deeper drilling in early 2026 to explore high-grade zones and untested anomalies.

Augustus Minerals has secured heritage approval for drilling at its Music Well Gold Project, paving the way for a maiden 1,000-metre drilling campaign targeting the promising Clifton East prospect in early 2026.

Aristocrat Leisure and Light & Wonder have resolved their high-profile intellectual property litigation with a $190 million settlement and the withdrawal of disputed games from the market.

Pharmaceutical manufacturer ANO has been hit with a US FDA Import Alert, joining several Australian peers amid wider regulatory tensions. The company is mobilising expert consultants and preparing a petition to lift the alert within weeks.

Skylark Minerals Limited has applied for ASX quotation of 37.98 million fully paid ordinary shares from a previously approved placement, signalling a key step in its capital expansion strategy.

Mesoblast Limited reports a 60% jump in Ryoncil sales for the December quarter, underpinned by a new $125 million financing facility that strengthens its balance sheet and strategic flexibility.

QGold Pty Ltd has raised its takeover offer for Venus Metals Corporation shares to $0.21 and extended the offer period to 30 January 2026, signalling a firm final bid in the ongoing acquisition attempt.

Energy Transition Minerals (ETM) has appointed Ballard Partners as strategic advisors in the US, reinforcing its plan to list on the Nasdaq Stock Exchange and deepen its engagement with American stakeholders.

InhaleRx Limited has completed the final tranche of its share placement, raising $600,000 to support its clinical-stage drug development programs targeting pain and mental health.