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FDA Hits Pause on Argenica’s US Stroke Trial IND Application

9:00am on Tuesday 10th of June, 2025 AEST Biotechnology
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FDA Hits Pause on Argenica’s US Stroke Trial IND Application

9:00am on Tuesday 10th of June, 2025 AEST
Key Points
  • FDA places clinical hold on Argenica’s US IND application for Acute Ischaemic Stroke trial
  • Non-clinical data package deemed insufficient by FDA
  • Company expects detailed FDA feedback within 30 days
  • Australian Phase 2 trial progressing as planned with data expected Q3 2025
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