Latest Regulatory Progress News

CurveBeam AI Limited posted a strong 85% increase in revenue to $12.1 million for FY25, alongside a reduced net loss of $16.8 million. Despite operational improvements and a recent $11.58 million capital raise, the company flags material uncertainty over its ability to continue as a going concern.

Nova Eye Medical has reported a record A$29.3 million in FY25 revenue, driven by sustained US growth and operational improvements, setting the stage for breakeven EBITDA in the first half of FY26.

Neuren Pharmaceuticals reported a robust half-year with an 88% increase in net profit, driven by rising royalties from DAYBUE™ sales and progress in its NNZ-2591 clinical program. The company also completed a $39.6 million share buy-back, underscoring confidence in its growth trajectory.

NH3 Clean Energy has launched the FEED phase for its WAH2 clean ammonia project, advancing environmental approvals and commercial negotiations with potential strategic partners.

Cleo Diagnostics reported a $4 million loss for FY2025 while making significant strides toward FDA approval of its novel ovarian cancer blood test. The company is progressing clinical trials and scaling manufacturing in preparation for market entry.

Neurizon Therapeutics reported a $16.6 million loss for FY2025 amid significant progress in its lead neurodegenerative therapy NUZ-001, including regulatory milestones and a global licensing deal. The company is poised to enter a pivotal ALS clinical trial pending FDA clearance.

Lake Resources N.L. has updated its Kachi Phase One DFS Addendum, showcasing improved lithium brine grades, enhanced extraction technology, and stronger project economics, positioning the Kachi lithium project closer to development.

Ballard Mining reports strong infill and extensional drilling results at its Mt Ida Gold Project, confirming and potentially expanding the high-grade Baldock resource. The ongoing program aims to upgrade resource confidence and supports future development plans.

Bio-Gene Technology Limited reported a net loss of AUD 2.58 million for FY2025 while making significant strides in developing its bio-insecticides Flavocide and Qcide, securing US Department of Defense grants and expanding global partnerships.

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.

Taiton Resources has completed heritage surveys at its Challenger West and Highway projects, paving the way for targeted drilling programs in South Australia. The company has also submitted an environmental application to support these upcoming exploration activities.