Latest Regulatory Approvals News

Optiscan Imaging Ltd has launched a fully underwritten $17.75 million entitlement offer to fund clinical trials and regulatory clearances for its medical devices, marking a pivotal step in its transition to a commercial medical device manufacturer.

Critical Metals Corp has signed a multi-year letter of intent to supply rare earth concentrate from its Greenland project to Ucore Rare Metals’ US Department of Defense-backed processing facility, aiming to build a China-independent supply chain.

Karoon Energy’s 2025 half-year results reveal a 4% rise in production alongside a significant drop in profits, driven by lower oil prices and increased costs. The company advances key projects and completes its Baúna FPSO acquisition, setting the stage for future growth.

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

Apiam Animal Health reported modest revenue growth but a sharp net profit decline in FY25, launching a Strategic Reset program under new leadership. The company also received a $0.88 per share acquisition proposal from Adamantem Capital Management.

Terragen Holdings reported a $3.72 million loss for FY25, impacted by drought and lower revenues, while launching dry probiotic products targeting feedlots and completing a $4.76 million equity raise.

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.