Latest Regulatory Filings News

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.

WA Kaolin Limited has responded to ASX queries clarifying that its Q2 FY2026 order book was a demand snapshot, not a sales forecast, and confirmed timely disclosure of a production shortfall linked to plant issues. The company also addressed regulatory notices, affirming no material impact on operations or securities value.

Immutep Limited has voluntarily suspended trading of its shares on the ASX pending the release of a key announcement regarding the interim futility analysis of its TACTI-004 Phase III trial. The suspension underscores the market’s anticipation of potentially pivotal clinical trial results.

Dimerix Limited has completed dosing of the last adult patient in its ACTION3 Phase 3 trial for DMX-200, exceeding its recruitment target and setting the stage for key regulatory milestones.

Tetratherix Limited has raised approximately $5 million to fast-track its Tutelix prostate spacer into pivotal clinical trials across Australia and the US, aiming to improve radiation therapy for prostate cancer patients.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Viking Mines has successfully identified multiple new high-priority tungsten targets at its Linka Project in Nevada through cutting-edge gravity and magnetic surveys, prompting an expanded exploration program.

Greenwing Resources has updated its Que River Project scoping study, reflecting a sharp rise in metals prices that boosts projected cash flows to nearly double previous estimates. The company is advancing regulatory approvals and exploring strategic partnerships to capitalise on these improved economics.