Dimerix Secures US$30M Upfront, Eyes AU$1.4B in Licensing Milestones
Dimerix has secured a significant licensing agreement with Amicus Therapeutics for its kidney disease drug candidate DMX-200 in the US, receiving a US$30 million upfront payment and advancing its Phase 3 trial with FDA endorsement of a key clinical endpoint.
- Exclusive US license deal with Amicus Therapeutics for DMX-200
- Up to US$590 million in upfront, milestone payments, and royalties
- Over AU$65 million received from four licensing deals to date
- FDA accepts proteinuria as primary endpoint for US approval
- Strong cash position of AU$68.3 million supports ongoing Phase 3 trial
Dimerix Secures Major US Licensing Agreement
Australian biopharmaceutical company Dimerix Limited (ASX, DXB) has announced a landmark licensing agreement with Amicus Therapeutics for its Phase 3 drug candidate DMX-200, targeting the rare kidney disease focal segmental glomerulosclerosis (FSGS) in the United States. The deal includes an upfront payment of US$30 million (approximately AU$48 million), received in May 2025, and potential milestone payments and royalties that could total up to US$590 million (around AU$940 million).
This agreement marks the fourth licensing deal for DMX-200, following partnerships with Advanz Pharma, Taiba, and Fuso Pharmaceutical Industries Ltd. Collectively, these deals offer Dimerix potential payments exceeding AU$1.4 billion plus royalties, with over AU$65 million already received. The Amicus deal specifically covers all indications for DMX-200 in the US, underscoring the drug’s commercial promise in a key market.
Progress in Clinical Development and Regulatory Milestones
Alongside the licensing success, Dimerix continues to advance its ACTION3 Phase 3 clinical trial, evaluating DMX-200’s efficacy in patients with FSGS. The trial has enrolled 219 patients to date, with over 190 clinical sites activated globally, including specialist pediatric clinics. A significant regulatory milestone was achieved with the US Food and Drug Administration (FDA) confirming proteinuria, a measure of protein in urine, as an acceptable primary endpoint for marketing approval. This endorsement is crucial, as proteinuria is a recognized surrogate marker for kidney disease progression.
The trial’s design includes a double-blind, randomized, placebo-controlled format, with patients receiving DMX-200 alongside standard angiotensin II receptor blocker therapy. An open-label extension study is also underway, allowing patients continued access to DMX-200 post-trial, which will provide valuable long-term safety and efficacy data.
Financial Strength and Future Outlook
Dimerix ended the June 2025 quarter with a robust cash balance of AU$68.3 million, up from AU$17.0 million at the end of March, reflecting net operating cash inflows of AU$45.6 million. The company anticipates some one-off costs in the coming quarter related to the US licensing transaction and clinical trial milestones but remains well-funded to continue its pivotal Phase 3 program and explore further licensing opportunities in unlicensed territories.
Beyond DMX-200, Dimerix is also developing DMX-700 for respiratory diseases, leveraging its proprietary Receptor-Heteromer Investigation Technology platform. The company’s strategic partnerships and strong cash position position it well to advance its pipeline and potentially deliver new treatment options for patients with inflammatory and kidney diseases.
Bottom Line?
With a major US licensing deal secured and FDA endpoint clarity, Dimerix is poised for critical clinical and commercial milestones ahead.
Questions in the middle?
- Will the final ACTION3 trial results confirm the early positive proteinuria outcomes?
- How quickly will milestone payments from Amicus and other partners materialize?
- What new territories might Dimerix target next for licensing DMX-200?
