Dimerix Confirms Strong Statistical Power and Refines Strategy for Phase 3 FSGS Trial

The latest update is out from Dimerix Limited ( (AU:DXB) ).

Dimerix has confirmed that its Phase 3 ACTION3 trial of DMX-200 in FSGS remains statistically well powered, with a blinded external review showing more than a 90% chance of demonstrating a significant treatment effect on the primary endpoint of proteinuria if current trends continue. The company and its partners will continue the study through to the final proteinuria endpoint, supported by evolving regulatory and clinical evidence that proteinuria is an appropriate primary measure for full approval and that this focus reduces both clinical and commercial risk.

The adult cohort of the ACTION3 trial is now fully recruited with 333 patients, and the last adult dose is expected in March 2028, while recruitment of adolescents aged 12–17 continues as an independent cohort that could underpin label expansion. Dimerix has opted against pursuing an interim analysis aimed at accelerated approval, concluding that maintaining proteinuria as the primary endpoint with eGFR as secondary offers a clearer, lower‑risk regulatory path, backed by earlier futility success, multiple clean safety reviews, and recent external data and regulatory precedents in FSGS.

The most recent analyst rating on (AU:DXB) stock is a Buy with a A$1.46 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 is an Australian biopharmaceutical company focused on developing DMX-200, a Phase 3 clinical asset targeting kidney disease, particularly Focal Segmental Glomerulosclerosis (FSGS). The company is advancing its late-stage clinical program while pursuing licensing discussions in territories not already partnered, aiming to position DMX-200 as a new treatment option in major markets.

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