Latest Regulatory Filings News

Micro-X Ltd has secured a $4.4 million Australian Government grant to develop and trial a portable Head CT scanner designed for standard ambulances, aiming to transform emergency stroke care with faster diagnosis and treatment.

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.

Neurizon Therapeutics has locked in a significant R&D tax incentive advance covering overseas and domestic development costs for its lead ALS drug candidate NUZ-001, accelerating its clinical progress with a $5.6 million rebate expected in 2025.

Neurizon Therapeutics has raised $5 million through an institutional placement to advance its lead ALS drug candidate NUZ-001 into a pivotal clinical trial, pending FDA clearance. The capital injection also supports manufacturing and pre-clinical development efforts.

Orthocell’s nerve repair device Remplir is being adopted in Australia for nerve-sparing prostate cancer surgeries, aiming to reduce erectile dysfunction and urinary incontinence post-operation. This development could significantly expand Remplir’s market reach globally.

Carbonxt Group has successfully closed its non-renounceable pro-rata entitlement offer, issuing over 51 million Loyalty Options and raising approximately $514,000 to support its expansion plans.

Warriedar Resources has received ASIC approval to delay its 2025 AGM until January 2026, allowing time for critical shareholder votes on proposed share option schemes tied to a Capricorn Metals acquisition.

Camplify Holdings has responded to ASX concerns over a delayed director interest notice, revealing internal process failures and promising tighter compliance measures.

News Corporation has completed a $450 million secondary offering of Class B shares by key Murdoch family trusts, alongside a new stockholders agreement that reshapes family voting power and share transfer rights.

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

Orthocell Limited reports an 81.1% overall treatment success rate from its Remplir Real World Evidence study, reinforcing the product’s safety and efficacy as it expands sales in the US and prepares regulatory submissions for the EU and UK.