Latest Regulatory News

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.

Kip McGrath Education Centres announces a one-year on-market share buy-back of up to 10% of its shares, aiming to enhance shareholder value amid strong cash reserves and profitability forecasts.

Integral Diagnostics Limited (ASX – IDX) reported a robust FY25 performance, boosted by its transformative merger with Capitol Health Limited. The company posted strong revenue and profit growth, declared a 4.0 cent final dividend, and outlined strategic priorities including AI adoption and teleradiology expansion.

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.

Kaili Resources has responded to an ASX price query following a dramatic rise in its share price, denying any undisclosed material information and confirming full compliance with ASX listing rules.

Kip McGrath Education Centres Limited reported modest revenue growth and a solid increase in EBITDA for FY25, despite a significant net loss driven by its exit from the US market. The company declared a fully franked final dividend, signaling confidence in its refocused core business.

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.

Amplia Therapeutics has successfully raised A$2.65 million through its Share Purchase Plan, exceeding expectations and bolstering funding for pivotal clinical trials of its lead drug narmafotinib.

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.

CleanSpace Holdings Limited reported a 26% increase in revenue to $19.8 million for FY25, alongside a significant reduction in net loss to $478,276. The company’s strategic expansion and innovation efforts underpin its improving financial health and global market presence.