Appendix 4E and 2025 Annual Report
| Stock | Dimerix Ltd (DXB.ASX) |
|---|---|
| Release Time | 28 Aug 2025, 9:06 a.m. |
| Price Sensitive | Yes |
Dimerix Reports 2025 Annual Results
- Licensing deals with Amicus Therapeutics and FUSO Pharmaceutical worth up to ~AU$1.4 billion
- Positive Type C meeting with FDA on potential new proteinuria endpoints for FSGS
- Continued progress in ACTION3 Phase 3 clinical trial for lead drug candidate QYTOVRA®
Dimerix Limited, a leading Australian biotech company, has reported exceptional results for the 2025 financial year, marked by robust growth, strategic execution, and significant progress in the development and commercialization of its lead drug candidate, QYTOVRA®. The company expanded its global partnerships for QYTOVRA®, securing two new licensing agreements with Amicus Therapeutics and FUSO Pharmaceutical Industries, collectively worth up to ~AU$1.4 billion in upfront, milestone, and royalty payments. This has significantly strengthened Dimerix's balance sheet, with over AU$65 million in total payments received to date. The company's flagship Phase 3 clinical trial, ACTION3, continued to make excellent progress, with over 190 clinical sites activated across 22 countries and the initiation of the first paediatric trial sites. Dimerix also held a positive Type C meeting with the US Food and Drug Administration, which confirmed that a proteinuria-based endpoint would be acceptable for full marketing approval in the US. Looking ahead, Dimerix remains focused on advancing its pipeline, expanding global partnerships, strengthening operational resilience, and delivering sustainable, long-term value to all stakeholders.
Dimerix expects to receive potential development milestone payments from its existing licensing partners if certain milestones are achieved. The company is also pursuing additional licensing opportunities for QYTOVRA® in available territories.
Dimerix is confident in its ability to execute on its strategic priorities, which include advancing its pipeline with speed and scientific excellence, expanding global partnerships for QYTOVRA®, strengthening operational resilience and capabilities, and delivering sustainable, long-term value to all stakeholders.