Latest Regulatory Filings News

Micro-X has completed its first Head CT test bench, marking a key milestone as it begins pivotal imaging trials in Australian hospitals to revolutionize stroke diagnosis.

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

ReNerve Ltd is rapidly advancing its nerve repair product portfolio, with four ranges expected on the market by the end of 2025 and expanding global distribution. Clinical studies highlight significant patient benefits, supporting the company’s growth in a booming biomaterials market.

EMVision Medical Devices launches a $2 million Share Purchase Plan offering shares at a 16.4% discount, bundled with free options exercisable at $3.40, aiming to bolster clinical and commercial milestones.

Cobalt Blue Holdings has completed the issuance of over 22 million shares following a placement announced earlier this month, leveraging its ASX capacity. The move marks a key step in the company’s capital strategy without requiring additional disclosure.

EMVision Medical Devices has initiated a unique pre-hospital study in Melbourne to test its First Responder Brain Scanner within one of the world’s few Mobile Stroke Units, aiming to enhance stroke diagnosis and accelerate commercialisation.

Vonex Limited shareholders have overwhelmingly approved Maxo Telecommunications’ acquisition scheme, setting the stage for a court decision that could delist Vonex from the ASX.

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.

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.