Latest Regulatory Approvals News

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.

PYC Therapeutics strengthened its financial footing with a $600 million capital raise and made notable clinical progress across four RNA therapeutic programs targeting genetic diseases.

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.

Alterity Therapeutics posted a 285% jump in revenue to A$1.72 million but also a 93% rise in net loss to A$23.4 million for FY2026. The company secured FDA alignment on a single pivotal Phase 3 trial for ATH434 in Multiple System Atrophy, setting the stage for trial start by year-end.

Minerals 260 has secured an expanded mining lease and acquired additional tenements, significantly enlarging its Bullabulling Gold Project footprint and advancing towards a final investment decision in early 2027.

Bio-Gene Technology narrowed its loss to $2.33 million in FY26 while progressing key toxicity studies for Flavocide and securing a commercial foothold for Qcide in Japan. The company bolstered its balance sheet with a $3.275 million capital raise to fund ongoing development and production scale-up.

Foresta Group Holdings reports a doubling of its net loss to $6.8 million for FY2026 amid steady progress on its Kawerau biomass facility, highlighted by a long-term lease and key technical studies.

Berkeley Energia reported a $8.7 million net loss for FY2026 while pushing forward with its Salamanca uranium project and maiden critical minerals resource at Conchas. The company continues a $1.25 billion ICSID arbitration claim against Spain over permitting delays.

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.

Micro-X Limited lifted revenues by 16% to $15.1 million for FY26 but posted a $9.9 million net loss, narrowing from the prior year. The company advanced key medical imaging milestones and initiated a strategic reset to sharpen commercial focus and reduce costs.

SomnoMed reported a 3% revenue rise to $114.5 million and a 19% EBITDA increase to $10.9 million in FY26, navigating European market headwinds and a CEO transition while launching its Virtus device targeting sleep apnea with bruxism.

ECS Botanics boosted revenue by 10% to $21.4 million in FY26, delivering positive EBITDA and operating cash flow while advancing international market entry and branded product growth.