Latest Regulatory Filings News

Actinogen Medical has initiated the open-label extension of its XanaMIA Alzheimer’s trial, offering all participants active Xanamem treatment for up to 25 months to gather long-term safety and efficacy data ahead of final trial results.

Kairos Minerals has secured shareholder approval to rebrand as Pilbara Gold Limited and consolidate its shares on a 1-for-15 basis, signalling a new chapter for the company’s gold exploration ambitions.

Optiscan Imaging Ltd has taken a significant step towards commercialising its InSpecta® veterinary imaging device in the US by submitting a regulatory dossier to the FDA. This milestone not only initiates formal review but also sets the stage for broader clinical adoption and future device approvals.

Papyrus Australia has commissioned its Adelaide Rapid Prototyping & R&D Facility, marking a key step in validating its pulp technology and progressing towards commercial production. The company also released its interim financials and reported stable cash flow supporting ongoing operations.

Patrys Limited is advancing a proprietary injectable formulation of quetiapine aimed at the large and underserved delirium treatment market, leveraging an accelerated FDA approval pathway and extensive existing safety data.

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

SQX Resources has addressed an ASX compliance query regarding director Bevan Tarratt’s trading during a closed period, confirming prior board approval and an administrative disclosure error.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.

ASX Compliance has formally queried Reckon Limited regarding a late filing of a director interest notice, raising potential breaches of key listing rules. The company must respond swiftly to avoid trading disruptions.

CLINUVEL Pharmaceuticals reports record first-half profits and confirms CEO Philippe Wolgen’s leadership through a pivotal growth phase, prioritising its vitiligo program and Nasdaq ambitions.

Merino & Co. Limited has attributed the late lodgement of director interest notices to an administrative oversight and reaffirmed its compliance measures to meet ASX disclosure rules.