Dimerix Ltd Advances Phase 3 Trial in Japan, Triggers A$4.3 Million Milestone Payment

Key Highlights:

• First Japanese clinical site for DMX-200 Phase 3 trial activated
• A$4.3 million milestone payment from FUSO Pharmaceutical Industries triggered
• ACTION3 trial expands global footprint for FSGS treatment
• Dimerix market cap at A$334.76 million, shares up 26.37% over 12 months
   

Dimerix Ltd (ASX: DXB) has marked a significant milestone in its global clinical program, announcing the activation of the first clinical site in Japan for its pivotal Phase 3 ACTION3 trial of DMX-200, an investigational treatment for Focal Segmental Glomerulosclerosis (FSGS). The site opening triggers a ¥400 million (~A$4.3 million) milestone payment from Japanese partner FUSO Pharmaceutical Industries Ltd, with funds expected within 30 days.

Shares of Dimerix edged up 0.88% to $0.575 in Friday trading, reflecting investor optimism as the company progresses its late-stage clinical asset, DMX-200, through regulatory and commercial pathways across multiple jurisdictions. The stock has gained 26.37% over the past year, with a 52-week range of $0.300 to $0.785, positioning the biopharma as a standout in the Australian healthcare sector.

Dimerix’s CEO, Dr. Nina Webster, described the activation as “a major step forward” in the global strategy to deliver much-needed treatments for FSGS patients worldwide. The ACTION3 trial, targeting the severe and rare kidney disease that often leads to end-stage renal failure, is a multi-centre, randomised, double-blind study evaluating the efficacy of DMX-200 in patients on stable doses of angiotensin II receptor blockers (ARBs).

With no approved therapies for FSGS globally, Dimerix’s program has secured orphan drug designation in both the US and Europe—underscoring the unmet medical need and potential commercial upside. FUSO, the exclusive licensee for DMX-200 in Japan, is responsible for clinical development costs, regulatory submissions, and commercialisation in the region, while Dimerix retains global rights in unlicensed territories.

The milestone payment forms part of Dimerix’s broader licensing strategy, which could unlock up to A$1.4 billion in cumulative payments across four regional deals, excluding future royalties on net sales.

Looking ahead, Dimerix is focused on patient recruitment in Japan—approximately 20 participants are expected for the Japanese arm of the trial—while continuing site activations globally. The company remains committed to advancing its proprietary DMX-200 and DMX-700 programs, leveraging its Receptor-HIT platform to address high-value inflammatory and kidney disease markets.

With a market cap of A$334.76 million and 582.18 million shares on issue, Dimerix stands at a critical juncture. The company’s progress in Japan could signal a turning point for its global ambitions, as investors monitor trial milestones and potential regulatory approvals that could unlock commercial pathways in major healthcare markets.