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FDA Endorsement Boosts Dimerix’s DMX-200 Path to Approval

Story Highlights
  • Dimerix Limited focuses on therapies for unmet medical needs in kidney diseases.
  • FDA’s acceptance of proteinuria as a primary endpoint could expedite DMX-200’s approval.
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Dimerix Limited ( (AU:DXB) ) has issued an announcement.

Dimerix Limited announced a significant development in its Phase 3 clinical trial for DMX-200, as the FDA confirmed proteinuria as an acceptable primary endpoint for full marketing approval in the US for treating Focal Segmental Glomerular Sclerosis (FSGS). This decision aligns with Dimerix’s previous clinical findings and could potentially expedite the drug’s market entry, offering hope for patients with this progressive disease.

More about Dimerix Limited

Dimerix Limited is a biopharmaceutical company focused on developing innovative therapies for areas with unmet medical needs. The company is headquartered in Fitzroy, Victoria, Australia, and is actively working on a Phase 3 clinical asset, DMX-200, targeting rare kidney diseases.

YTD Price Performance: 33.82%

Average Trading Volume: 1,498,581

Technical Sentiment Signal: Strong Sell

Current Market Cap: A$254.5M

Find detailed analytics on DXB stock on TipRanks’ Stock Analysis page.

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