Latest Regulatory Challenges News

Carnegie Clean Energy has signed a pivotal Memorandum of Understanding with BiMEP to develop a 6MW wave energy array in Spain’s Basque Country, marking a significant step in commercialising its CETO technology.

Imricor Medical Systems reported significant regulatory and commercial progress in Q2 CY25, including CE mark approvals and expanded clinical trials, while maintaining a strong cash position.

Peak Rare Earths advances its Ngualla project with a proposed A$158 million acquisition by Shenghe Resources, alongside a successful A$7.5 million capital raise and rising rare earth prices.

Macquarie Group Limited reported a 5% increase in FY25 profit to A$3.715 billion, declaring a higher dividend and announcing a key CFO transition. The group also outlined a strategic divestment and cautious outlook for FY26.

Argenica Therapeutics has dosed the final patient in its Phase 2 trial for ARG-007 in acute ischaemic stroke, with topline results expected in Q3 2025. Meanwhile, the FDA has placed a clinical hold on its US trial application, introducing uncertainty for US development.

InhaleRx Limited has secured key ethics approvals and initiated manufacturing for its inhaled drug candidates targeting breakthrough cancer pain and panic disorder, supported by a $38.5 million funding facility to accelerate development.

The Virginia Supreme Court has affirmed the State Corporation Commission’s decision to deny a toll rate increase for the Dulles Greenway, owned by Atlas Arteria. Meanwhile, a related federal case alleging constitutional violations will now proceed.

G8 Education faces ASX scrutiny over its handling of sensitive information about a former employee, with the regulator questioning the company’s disclosure practices despite GEM’s insistence of compliance.

The Takeovers Panel has decided not to proceed with an application challenging Keybridge Capital’s board decisions amid Yowie Group’s takeover bid, citing prior rulings and no unacceptable circumstances.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.

Kinatico Limited has reported a record FY25 revenue of $32.1 million, driven by a remarkable 54% increase in SaaS revenue and a cash-positive year despite significant technology investments.

C29 Metals has exited its Kazakhstan operations to focus on advancing its Mayfield Copper & Gold Project in Queensland, securing a three-year exploration license extension and confirming strong geological potential.