Latest Dimerix (ASX:DXB) News

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in FSGS kidney disease has passed its seventh Independent Data Monitoring Committee review with no safety concerns, reinforcing the drug’s promising safety profile.

Dimerix Limited reports solid progress in its Phase 3 trial for DMX-200 targeting rare kidney disease FSGS, backed by orphan drug status in Japan and a robust cash position. The company prepares to engage the FDA on new data supporting regulatory approval.

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

Dimerix Limited’s lead drug candidate DMX-200 has been granted Orphan Drug Designation in Japan for treating Focal Segmental Glomerulosclerosis (FSGS), enhancing its regulatory and commercial prospects in a key market.

Dimerix Limited reported a 22% reduction in its FY2025 loss to $13.25 million, driven by strong licensing revenues and advancing its pivotal Phase 3 clinical trial for DMX-200. The company secured new global partnerships valued at up to AU$1.4 billion, bolstering its cash reserves and commercial prospects.

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.

Dimerix Limited has received a significant milestone payment from its Japanese partner FUSO Pharmaceutical, marking progress in the Phase 3 clinical trial of DMX-200 for kidney disease. This payment underscores the growing momentum behind Dimerix’s global licensing strategy.

Dimerix has reached a key milestone by dosing 200 adult patients in its Phase 3 ACTION3 trial for FSGS, progressing steadily toward full recruitment expected in late 2025.

Dimerix has activated the first clinical trial site in Japan for its pivotal Phase 3 ACTION3 study targeting FSGS, triggering a significant milestone payment from its Japanese partner FUSO Pharmaceutical.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in treating FSGS kidney disease has passed its sixth independent safety review with no concerns, reinforcing the drug’s promising safety profile.

Dimerix has received a US$30 million upfront payment from Amicus Therapeutics for exclusive US rights to DMX-200, a promising kidney disease therapy. The deal positions Dimerix for up to US$560 million in further milestones plus royalties, underpinning its global licensing strategy.