Dimerix Gains FDA Endorsement of Key Endpoint for Phase 3 FSGS Trial

Dimerix Limited ( (AU:DXB) ) has shared an update.

Dimerix has received written feedback from the U.S. Food and Drug Administration confirming that percent reduction in proteinuria at two years is an appropriate primary endpoint to support traditional approval of its Phase 3 candidate DMX-200 in FSGS, with change in eGFR to serve as a secondary endpoint. The agency has requested additional information and documentation to safeguard trial integrity before proceeding with a planned blinded statistical powering analysis for the ACTION3 Phase 3 study, pushing that analysis to early 2026 but reinforcing the regulatory path for DMX-200 in a rare kidney disease with no approved targeted therapies, a development that could be significant for patients and for Dimerix’s positioning in the FSGS treatment landscape.

The most recent analyst rating on (AU:DXB) stock is a Hold with a A$0.50 price target. To see the full list of analyst forecasts on Dimerix Limited stock, see the AU:DXB Stock Forecast page.

More about Dimerix Limited

Dimerix Limited (ASX: DXB) is a clinical-stage biopharmaceutical company focused on inflammatory diseases, particularly kidney conditions such as focal segmental glomerulosclerosis (FSGS). Its lead Phase 3 product candidate, DMX-200, is a CCR2 antagonist used alongside standard angiotensin II receptor blocker therapy, discovered via the company’s proprietary Receptor-HIT platform and supported by patent protection and orphan drug designation in the U.S.

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