Latest Regulatory Milestones News

CurveBeam AI’s FY2026 results show a 28% revenue decline and a 12% increase in net loss, while advancing its China commercialisation and robotic surgery integration strategies. The company also announced a $6-7 million capital raise post-year-end.

Singular Health Group lifted revenues over fivefold to $1.43 million in FY26, driven by US commercial rollouts of its 3DICOM platform, but posted a $6.34 million loss. The company strengthened its US foothold with FDA clearance and a controlling stake in an associate.

OncoSil Medical lifted revenues 44% in FY26 to $1.68 million and trimmed losses by 28% to $10.86 million, buoyed by key regulatory approvals including FDA HDE and Australian TGA listings. The company is poised for commercial launches in the US and Australia, with strong clinical data underpinning its growth.

4DMedical’s CT:VQ™ lung imaging technology secured FDA clearance and CMS reimbursement, driving rapid adoption in top US medical centres and expanding its addressable market to $3 billion with new clinical programs and European contracts.

Imricor Medical Systems and Philips have launched a combined interventional MR lab solution integrating Philips’ 1.5T BlueSeal MRI with Imricor’s MR-compatible systems, targeting cardiac electrophysiology and setting a new standard for MR-guided interventions.

Patrys has cleared a key regulatory hurdle with Human Research Ethics Committee approval for its Phase 1A clinical trial of RLS-2202, aiming to start dosing healthy volunteers this quarter.

Actinogen Medical reported a $15.38 million loss for FY2026 while progressing its lead Alzheimer's drug Xanamem toward pivotal trial results expected this November. The company secured regulatory alignment and strengthened its cash position to fund operations through mid-2027.

Bathurst Resources delivered a consolidated EBITDA of NZD 44.7 million for FY26, reaching the top of its guidance despite a challenging start to the year for export coal prices. The company advanced key growth projects in New Zealand and Canada while maintaining a robust cash position.

Argent BioPharma has secured a key FDA regulatory milestone with the establishment of an Investigational New Animal Drug (INAD) file for its CannEpil veterinary program, targeting cancer-related pain in companion animals.

Neuren Pharmaceuticals reported an 8% rise in H1 2026 revenues driven by DAYBUE royalties, but profit fell 68% due to ramped-up R&D. The company declared its first ever dividend, signalling confidence amid ongoing clinical and regulatory milestones.

Paladin Energy Ltd (ASX:PDN) reversed prior losses with a net profit of US$5.3 million in FY2026, driven by a strong ramp-up of uranium production at Namibia's Langer Heinrich Mine and regulatory progress at its Canadian Patterson Lake South Project.

HiTech Group has secured unconditional ACCC clearance for its acquisition of Hudson Global Resources’ Australian assets, removing a major regulatory obstacle ahead of completion.