Latest Regulatory Filings News

Recce Pharmaceuticals has secured a key patent in Hong Kong for its synthetic anti-infectives, reinforcing its intellectual property footprint in Asia and supporting its clinical and commercial ambitions in the region.

Audeara Limited has achieved a key regulatory milestone with NMPA certification in China, paving the way for commercial launch of its hearing personalisation technology through a leading e-commerce brand. This approval supports the company’s strategy to generate scalable licensing revenue in a rapidly growing market.

EMVision Medical Devices has begun a pivotal aeromedical study with the Royal Flying Doctor Service to test its portable First Responder brain scanner in remote emergency settings. The trial aims to validate device usability and workflow integration ahead of commercial rollout.

ASX Compliance has flagged Rent.com.au Limited for a late filing of a director’s interest change, raising questions about the company’s disclosure controls and compliance with listing rules.

Zelira Therapeutics has received a $1.07 million cash refund under Australia’s R&D Tax Incentive Scheme, reinforcing its funding for ongoing clinical trials and product development. The company has also repaid a prior loan advanced against this claim, positioning it for continued growth in cannabinoid-based medicines.

Metcash Limited has responded to an ASX query regarding the late filing of a director’s interest notice, attributing the delay to an administrative oversight and outlining plans to enhance compliance processes.

Mesoblast has achieved a landmark FDA approval for RYONCIL, the first allogeneic mesenchymal stromal cell therapy, driving strong commercial momentum and advancing a robust pipeline targeting inflammatory diseases.

Dusk Group Limited has addressed an ASX compliance query regarding the delayed disclosure of a director’s interest change, attributing the lapse to an administrative oversight while reaffirming its commitment to regulatory compliance.

Embark Early Education has revised the timeline for its conditional takeover bid of Mayfield Childcare, delaying key regulatory filings into early 2026.

DroneShield Limited has clarified the recent exercise and sale of shares by its directors following performance option vesting, alongside addressing an erroneous contract announcement that was later withdrawn. The company also outlined steps to enhance compliance with ASX continuous disclosure and trading policies.

Stealth Group Holdings has explained the late filing of a director’s interest notice as an administrative oversight, assuring no market harm occurred. The company has since strengthened its compliance controls to prevent future lapses.

5E Advanced Materials has announced a significant upgrade to its Fort Cady Project, increasing measured and indicated borate resources by 61% and lithium resources by 54%, positioning it as a leading domestic supplier of critical minerals.