Latest Regulatory Filings News

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.

Imricor Medical Systems has filed a Form 10 registration with the U.S. SEC, marking its transition to a U.S. reporting company amid ongoing FDA clearances and clinical trials. This move signals a significant step in its early commercialisation of MRI-guided cardiac ablation technology.

Biotron Limited reveals that its lead antiviral candidate BIT-HBV001 shows promising activity against Hepatitis Delta Virus, expanding its potential impact beyond Hepatitis B. Meanwhile, the company completes integration of Sedarex and advances regulatory plans for its anaesthetic SedRx.

Clarity Pharmaceuticals has unveiled compelling Phase II trial results showing its Cu-SAR-bisPSMA PET imaging agent significantly improves detection of prostate cancer recurrence over the current standard. The data, presented at the 2026 European Association of Urology Congress and accepted by European Urology journal, mark a key milestone ahead of regulatory submissions.

WA Kaolin Limited reported a $5.06 million half-year loss despite a 257% revenue surge, grappling with operational setbacks and regulatory challenges. The company’s recent debt restructuring and trading suspension signal a critical juncture as it seeks to stabilise and recapitalise.

Resonance Health has received a $732,851 refund from the Australian Taxation Office, reflecting its FY2025 R&D tax incentive claim net of income tax payable. This cash inflow strengthens the company’s financial position ahead of its March quarterly report.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.