Dimerix secures FDA feedback on ACTION3 Phase 3 trial

Dimerix (ASX:DXB), a biopharmaceutical company developing treatments for kidney disease, has received feedback from the US Food and Drug Administration on its ACTION3 Phase 3 trial of DMX-200 in patients with focal segmental glomerulosclerosis.

In written guidance, the FDA confirmed that the primary endpoint—percent reduction in proteinuria at two years—is appropriate to support full approval of DMX-200 under the 505(b)(1) pathway, with change in eGFR designated as a secondary endpoint.

The agency also requested additional information and documentation before the planned blinded statistical powering analysis could proceed.

Dimerix expects to provide the requested materials shortly, with the blinded analysis now anticipated in early 2026.