Latest Regulatory Approval News

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.

Race Oncology Limited reported a significantly reduced loss for FY2025, driven by key clinical trial progress and strategic leadership changes. The company advances its RC220 program with promising Phase 1 dosing milestones and strengthens its governance to support future growth.

Starpharma reports a significant 183% jump in FY25 revenue to $4.9 million, alongside a 31% reduction in losses and a solid cash position of $15.4 million. The biotech firm’s progress underscores growing momentum in its dendrimer technology pipeline.

Lincoln Minerals Limited is gearing up for drilling at its Minbrie copper-base metals project in South Australia, while reporting robust financial metrics for its graphite and high purity iron projects.

Emyria has begun treating the first Medibank-funded PTSD patients at its Perth clinic, marking a pioneering step in private insurance coverage for psychedelic-assisted therapy in Australia. This milestone fuels rapid clinic expansion and supports the company’s national rollout strategy.

Evergreen Lithium has secured rights to two promising gold projects in Western Australia’s premier goldfields, significantly boosting its exploration footprint with minimal upfront cash outlay. The acquisitions position the company to leverage historical data and regional infrastructure as it advances toward becoming a gold producer.

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.

BlinkLab Limited has expanded its pivotal FDA autism diagnostic trial by partnering with two leading US pediatric institutions, enhancing recruitment and clinical credibility ahead of its 2026 submission.

Rhythm Biosciences has completed critical validation of its ColoSTAT colorectal cancer assay and submitted it for ISO15189 accreditation, paving the way for commercialisation. The test demonstrated strong clinical performance, highlighting its potential as a non-invasive diagnostic tool.

Imugene Limited reported a significant 54% reduction in net loss for FY25, driven by cost efficiencies and promising clinical progress in its immuno-oncology pipeline. The company’s lead asset, azer-cel, achieved a 79% response rate in Phase 1b trials and secured FDA Fast Track designation.

Tyro Payments Limited reported FY25 results with strong top-line growth and margin expansion, setting a confident outlook for FY26 backed by AI-driven efficiency and an expanded market.

EMVision Medical Devices is set to activate its sixth and final pivotal trial site at UCLA Health, advancing its emu™ brain scanner towards FDA submission. Meanwhile, the Continuous Innovation Study grows with the addition of Box Hill Hospital.