• Dimerix to conduct a blinded review of ACTION3 data to confirm statistical assumptions for the primary endpoint
• The blinded review aims to provide further confidence that the study remains powered to demonstrate a treatment effect
• The blinded review will use methods prespecified in the Statistical Analysis Plan and submitted to the FDA

Dimerix Limited, a biopharmaceutical company with a Phase 3 clinical asset in kidney disease, announced that it will conduct a blinded review of ACTION3 Phase 3 study data to confirm statistical assumptions of the primary endpoint during March 2026. The purpose of this blinded review, conducted by an independent third party, is to provide confidence that the study is tracking within the original statistical assumptions and confirm that the study remains able to show a benefit of DMX-200 compared to placebo, without knowledge of treatment assignments or treatment effect, thus maintaining study integrity. The FDA has previously confirmed that the proposed primary endpoint of percent reduction in proteinuria compared to placebo is suitable to support traditional approval of DMX-200 via the 505(b)(1) pathway, should the findings of the ACTION3 be positive, with change in eGFR as a secondary endpoint. Dimerix anticipates undertaking this blinded review in late March 2026, in line with the revised study protocol and the prespecified methods outlined in the ACTION3 Statistical Analysis Plan submitted to the FDA.

Dimerix is focused on ensuring the ACTION3 program remains appropriately powered to meet its primary endpoint, with the emphasis on proteinuria as a primary measure expected to strengthen the probability of success. The company remains committed to delivering value for patients and shareholders.