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FDA Endorses Proteinuria Reduction Endpoint in Dimerix’s Pivotal Kidney Trial

8:45am on Wednesday 24th of December, 2025 AEDT Healthcare
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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
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