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Dimerix Limited (ASX:DXB)

ALERT: Price-sensitive ASX Announcement for DXB
Current share price for DXB : $0.250 -0.14 (-35.90%)+
Announcement
Release
28 Apr 2026 9:20AM
Price at Release
$0.390
Full Release
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Summary
Dimerix Limited announced the completion of a blinded statistical review for the ACTION3 Phase 3 study, confirming it remains statistically powered to detect a treatment effect in proteinuria, the primary endpoint. The FDA supports proteinuria as an endpoint for regulatory approval of DMX-200. The adult cohort is fully recruited, while recruitment continues for adolescents. The study has passed a futility analysis, demonstrating better results than placebo. Proteinuria is confirmed as the primary endpoint, avoiding the risks associated with eGFR endpoints. Dimerix has chosen not to pursue interim analysis for accelerated approval, focusing instead on achieving traditional approval through the 505(b)(1) pathway.
Key Points
  • An external statistical blinded review of ACTION3 data confirmed the study's statistical power is over 90% to demonstrate a treatment effect for proteinuria.
  • Dimerix continues the ACTION3 Phase 3 study to the final proteinuria endpoint to increase chances of regulatory success.
  • FDA agreed that proteinuria is an appropriate endpoint for full regulatory approval of DMX-200 in ACTION3.
  • Recruitment for pediatric patients remains ongoing, potentially allowing expansion to adolescents.
  • ACTION3 Phase 3 study passed a formal futility analysis in March 2024, showing better performance than placebo.
  • Proteinuria is confirmed as the primary endpoint, which is statistically more achievable than eGFR endpoints.
  • Dimerix decided against pursuing an interim analysis for accelerated approval due to added costs and risks.
  • The study aims for traditional approval through the 505(b)(1) pathway with proteinuria as the primary endpoint and eGFR as a secondary endpoint.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.