Dimerix Hits Phase 3 Recruitment Target for Lead Kidney Drug as FDA Backs Approval Pathway

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

Dimerix reported strong operational progress in the December 2025 quarter as its pivotal ACTION3 Phase 3 trial of DMX-200 in adult FSGS patients reached its full target recruitment of 286 adults, with pediatric enrolment continuing as an independent cohort to potentially broaden the treatment’s label. The company also received positive regulatory feedback from the US FDA confirming that proteinuria reduction remains an acceptable primary endpoint for traditional approval, supported by new PARASOL registry data that reinforce the clinical relevance of proteinuria and may underpin both full and accelerated approval strategies in multiple territories. Financially, Dimerix closed the quarter with AU$38.5 million in cash and net operating outflows of AU$11.1 million, largely driven by clinical milestones and R&D spending, leaving it well funded to continue the ACTION3 trial, maintain an open-label extension that retains most completing patients on DMX-200, and pursue additional pipeline and licensing opportunities amid sector interest highlighted by BioMarin’s planned acquisition of its US partner Amicus Therapeutics.

The most recent analyst rating on (AU:DXB) stock is a Hold with a A$0.56 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 Australia-based biopharmaceutical company focused on developing DMX-200, a Phase 3 clinical asset targeting focal segmental glomerulosclerosis (FSGS), a rare kidney disease. The company’s core activities center on late-stage clinical development, regulatory engagement, and partnering strategies to secure marketing approvals and commercialisation opportunities across major global markets, including the US, Europe and Asia.

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Technical Sentiment Signal: Buy

Current Market Cap: A$312.2M

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