Latest Asx Companies News

Lumos Diagnostics has secured its largest-ever order for FebriDx® following FDA clearance, signalling a major expansion in the US market opportunity.

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.

Aroa Biosurgery has completed its Symphony randomised controlled trial, demonstrating improved healing rates for diabetic foot ulcers compared to standard care. The preliminary results pave the way for clinical adoption and potential US reimbursement.

Cynata Therapeutics has completed the 100-day primary evaluation period for its Phase 2 trial of CYP-001 in acute graft versus host disease, with results expected in June 2026. This milestone marks a critical step for the biotech’s lead cell therapy candidate in a condition with few effective treatments.

Radiopharm Theranostics has initiated dosing in its Phase 1 clinical trial of RAD 402, a novel radiolabelled antibody targeting KLK3 in advanced prostate cancer. Early data from the trial’s initial dose levels are expected in the second half of 2026.

BCAL Diagnostics is expanding access to its Avantect pancreatic and ovarian cancer blood tests across Australia through partnerships with major pathology providers. This move marks a significant step in making early cancer detection more widely available.

Etherstack plc has secured a significant revenue uplift from a scope change in its primary UK government project, adding £1.53 million to its future earnings forecast for FY27.

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.

AdAlta Limited has been granted a key Canadian patent for its anti-fibrotic drug AD-214, completing its composition of matter protection across all major commercial markets. This milestone strengthens the company’s intellectual property portfolio and underpins its commercial strategy for AD-214.

Aguia Resources has secured key mining concessions in Brazil, setting the stage for operational licensing and commissioning of its Tres Estradas phosphate mine by April 2026.

Nexalis Therapeutics has initiated its Phase 1 trial for IRX-616a, an inhaled cannabidiol treatment aimed at panic disorder, marking a significant step in developing rapid-onset anxiety therapies.

Clarity Pharmaceuticals has reported a steep 136% increase in its half-year loss to $55.6 million, alongside the closure of its European subsidiary, signaling a challenging period for the ASX-listed biotech.