Dimerix Over-Recruits in Pivotal FSGS Phase 3 Trial as Last Adult Patient Dosed

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

Dimerix has completed enrolment and first dosing of the last adult patient in its pivotal ACTION3 Phase 3 trial of DMX-200 for focal segmental glomerulosclerosis, bringing adult recruitment to 333 patients and closing further adult recruitment. The over-recruitment beyond the original 286-patient target is expected to enhance statistical power, with the two-year treatment period now running to March 2028 and the study having passed seven independent safety reviews without protocol changes.

The global trial spans 219 sites across 21 countries and evaluates DMX-200 in combination with angiotensin II receptor blockers, aiming to demonstrate reductions in proteinuria and preservation of kidney function sufficient to support marketing approval. Building on positive interim efficacy data and recent PARASOL collaboration findings, Dimerix plans additional statistical powering work aligned with U.S. regulatory guidance while advancing licensing discussions in unpartnered territories, underscoring its drive toward eventual regulatory submission and commercialisation of DMX-200.

The most recent analyst rating on (AU:DXB) stock is a Hold with a A$0.42 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 innovative therapies for diseases with significant unmet medical need, particularly kidney disorders. Its lead asset, DMX-200, is in Phase 3 development for focal segmental glomerulosclerosis, targeting global markets through a multi-country clinical program and licensing partnerships.

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Technical Sentiment Signal: Hold

Current Market Cap: A$243.2M

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