Latest Regulatory Approval News

Imricor Medical Systems reports significant regulatory approvals and clinical trial progress, positioning itself as a disruptive force in the growing electrophysiology market. With a strengthened commercial pipeline and solid cash reserves, the company is poised for a pivotal growth phase.

Imricor Medical Systems reported a sharp 52% revenue decline and a 92% increase in net loss for H1 2025, offset by a $42.8 million equity raise boosting liquidity. The company is investing heavily in European sales and clinical trials while pursuing FDA approval.

Genesis Energy reported a robust FY25 with a 14% rise in normalised EBITDAF and a 29% jump in net profit, driven by strategic portfolio flexibility amid volatile energy markets. The company accelerated its Gen35 strategy, including key renewable projects and long-term capacity contracts to bolster New Zealand’s energy security.

Metals X Limited reported a robust half-year to June 2025 with profit after tax soaring 256% to $52.9 million, driven by higher tin sales and prices from its Renison joint venture. The company also progressed key projects and deepened strategic investments while reinforcing its ESG and safety frameworks.

Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.

Platinum Asia Investments Limited has refined the payout figure for its final special dividend, enhancing precision for shareholders ahead of the September payment date.

PolyNovo Limited reported a robust 28.9% increase in group sales to A$118.6 million for FY25, alongside a 151% surge in net profit after tax to A$13.2 million, driven by strong U.S. growth and key regulatory approvals.

InhaleRx Limited reported a widening half-year loss as it accelerates clinical trials for inhaled drug-device therapies, supported by a substantial $38.5 million funding facility.

Karoon Energy has upgraded its 2025 production guidance even as a key downhole pump failure at its Baúna Project in Brazil restricts output. The company is planning a rig-based intervention to restore full capacity by mid-2026.

Dome Gold Mines has announced a $5 million Share Purchase Plan at a 6.25% discount to fund critical milestones for its Sigatoka Sands Project in Fiji, aiming to secure a mining licence and commence operations.

Noxopharm has successfully completed the third dosing phase of its HERACLES trial for SOF-SKN™, confirming safety and moving forward to the highest dose cohort in this pioneering autoimmune drug study.

An independent in vivo study from the University of South Florida reveals ArtemiC™ significantly boosts survival and reduces inflammation in a severe viral model, reinforcing its promise as a novel immunomodulatory therapy.