Dimerix (ASX:DXB) said the US Food and Drug Administration (FDA) confirmed the proposed primary endpoint of percent reduction in proteinuria compared to placebo, which supports approval of drug candidate DMX-200, in the ACTION3 trial for patients with Focal Segmental Glomerulosclerosis, a type of kidney disease, according to a Wednesday filing with the Australian bourse.

The US FDA has requested further information and documentation, which the company expects to provide shortly, the filing said.

The company expects the blinded analysis for the trial to occur in early 2026, the filing added.