middle.news
FDA Endorses Proteinuria Reduction Endpoint in Dimerix’s Pivotal Kidney Trial
8:45am on Wednesday 24th of December, 2025 AEDT
•
Healthcare
Read Story
FDA Endorses Proteinuria Reduction Endpoint in Dimerix’s Pivotal Kidney Trial
8:45am on Wednesday 24th of December, 2025 AEDT
Key Points
FDA confirms proteinuria reduction at 2 years as primary endpoint for DMX-200 approval
Blinded statistical powering analysis delayed to early 2026 pending additional FDA documentation
ACTION3 trial targets focal segmental glomerulosclerosis (FSGS), a rare kidney disease
DMX-200 holds orphan drug designation and patent protection through 2032, with extensions possible
Read Story
middle.
Tap to Read
Tap the card to read the full analysis
about
Dimerix (ASX:DXB)
OPEN ARTICLE