Latest Regulatory Approval 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.

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.

Scentre Group has announced its actual ordinary dividend for the six months ended June 2025, alongside detailed currency options and dividend reinvestment plan pricing.

Zenith Minerals has secured final regulatory approval to commence Phase 2 of its RC drilling program at the Consolidated Dulcie Gold Project, aiming to convert a significant Exploration Target into a JORC-compliant resource.

Sparc Technologies reveals up to 60% corrosion reduction in graphene-enhanced water-based epoxy coatings, reinforcing its leadership in sustainable protective coatings innovation.

29Metals Limited has reversed a significant loss to report a $35.3 million net profit for the first half of 2025, driven by stronger production at Golden Grove and improved metal prices, while Capricorn Copper remains suspended amid ongoing water and regulatory challenges.

Holista Colltech has inked a binding supply and development agreement with US-based Regenerex Pharma to exclusively supply proprietary ovine collagen for advanced wound care products, targeting the lucrative US market initially with plans for global expansion.

Firebrick Pharma has secured an exclusive licensing agreement with Innorini Pte Ltd to distribute Nasodine products across Singapore, Malaysia, Brunei, and Mauritius, aiming to reduce marketing expenses and broaden market access.

Vulcan Steel Limited reported a 10.9% revenue decline in FY25 alongside a 24.1% drop in adjusted EBITDA, while announcing a fully underwritten NZ$96 million equity raise to fund the acquisition of Roofing Industries Limited. The deal marks Vulcan’s strategic entry into the New Zealand steel roofing and cladding market with expected earnings accretion and no change to its dividend policy.