Dimerix Limited (ASX:DXB) Secures Major Licensing Deal in Japan and FDA Endorsement for DMX-200
Regulatory Approval
The US FDA confirmed proteinuria as an acceptable primary endpoint for full marketing approval of Dimerix’s DMX-200 in focal segmental glomerulosclerosis (FSGS).
Licensing Agreement
Dimerix entered a development and license agreement with Fuso Pharmaceutical Industries Limited in Japan, set to receive up to ¥10.5 billion (~AU$107 million) in upfront, developmental, and sales milestones, plus 15-20% royalties on net sales.
Financial Results
The company ended the quarter with a cash position of AU$17 million as of March 31, 2025, and reported net operating cash outflows of AU$4.3 million.
Clinical Progress
Dimerix recruited its first paediatric patient in the ACTION3 Phase 3 clinical trial, with 183 patients currently randomised and dosed.
Partnering Developments
Alongside the Fuso deal, Dimerix has licensing agreements with Advanz Pharma and Taiba, collectively providing up to AU$458 million in upfront payments and potential milestones. The company continues to receive strong partnering interest for DMX-200.
Motley Fool contributor Kiarra Jackson has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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