Latest Regulatory Milestones News

BlinkLab is advancing its FDA 510(k) clinical trials for autism and ADHD diagnostics, completing its U.S. autism pilot phase and expanding European ADHD recruitment. A recent $7.66 million capital raise supports these efforts as the company targets regulatory approvals in 2026.

Dimerix has secured a significant licensing agreement with Amicus Therapeutics for its kidney disease drug candidate DMX-200 in the US, receiving a US$30 million upfront payment and advancing its Phase 3 trial with FDA endorsement of a key clinical endpoint.

AVJennings Limited shares will halt trading following court approval of a takeover scheme by PM Nominees C Pty Ltd, marking a pivotal shift for the property developer.

Xstate Resources has pushed back the closing date of its public offer to early August, setting the stage for a potential ASX re-listing by late August following key approvals and asset acquisition.

The South African Competition Commission has approved ASPI Isotopes’ offer to acquire Renergen Limited, marking a key regulatory milestone in the ongoing takeover process.

Amplia Therapeutics has launched a $27.5 million capital raising to advance its lead drug Narmafotinib, a promising FAK inhibitor showing superior efficacy in pancreatic cancer trials. The funds will support ongoing and new clinical studies, positioning the company for pivotal regulatory milestones.

Emmerson Resources’ latest Scoping Study confirms the White Devil Gold Project as a Major Mine, projecting robust financial returns and a seven-year mine life. With feasibility studies underway and a strategic JV structure, the project is poised for development in the Northern Territory.

Tetratherix Limited has marked a pivotal quarter with a $25 million ASX listing, an exclusive licensing agreement with Bio Optix for ophthalmic devices, and progress on FDA regulatory submissions for its prostate spacer product.

Paladin Energy reports a 33% production surge at its Langer Heinrich Mine alongside a key environmental milestone for its Canadian project and announces a new CEO appointment. The company outlines strong FY2026 guidance amid ongoing operational ramp-up.

Invex Therapeutics has broadened its collaboration with Tessara Therapeutics to explore Exenatide’s potential in Alzheimer’s disease, while successfully renewing key orphan drug designations in Europe and the US.

Inhalerx Limited has drawn $247,000 from a $38.5 million funding facility to advance clinical trials for its IRX-211 and IRX-616a drug candidates, reporting positive operating cash flow for the quarter ending June 2025.

InhaleRx Limited has secured key ethics approvals and initiated manufacturing for its inhaled drug candidates targeting breakthrough cancer pain and panic disorder, supported by a $38.5 million funding facility to accelerate development.