Dimerix (ASX:DXB) is poised to receive "substantial" milestone payments after completing the interim analysis to support the US Food and Drug Administration's (FDA) potential accelerated approval application of drug candidate DMX-200, according to a Dec. 24 report by Euroz Hartleys.

However, Euroz believes that the FDA's decision on whether the company should conduct an interim analysis has been pushed back by several weeks due to a lack of additional information and the outcome of a blinded analysis.

On Dec. 23, the USFDA confirmed the proposed primary endpoint of percent reduction in proteinuria compared to placebo, which supports approval of DMX-200, in the company's ACTION3 trial for patients with Focal Segmental Glomerulosclerosis, a type of kidney disease.

The FDA requested further information and documentation, which the company expects to provide shortly, Euroz noted.

The company also expects to conduct the blinded analysis in early fiscal 2026.

If the FDA agrees, the company can proceed with an interim analysis as early as planned, leading to the "substantial" milestones payments, Euroz said.

However, if the FDA does not approve, the company would need to complete the full two-year study, pushing back approval and the commercial timeline by about two years, Euroz added.

Euroz maintained the company's speculative buy rating and its price target of AU$1.68.

Shares of the company rose 4% at market close.