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Argenica Therapeutics Limited (ASX:AGN)

ALERT: Price-sensitive ASX Announcement for AGN
Current share price for AGN : $0.095 -0.015 (-13.64%)+
Announcement
Release
11 Jun 2026 8:33AM
Price at Release
$0.110
Full Release
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Summary
Argenica Therapeutics Limited has announced the successful completion of the final FDA requested assay for their lead drug candidate ARG-007 (xaranetide), demonstrating a clean safety profile in cardiac tissue. The completion of the GLP-compliant in vitro hERG assay showed no significant inhibition of the hERG cardiac potassium channel, addressing a critical FDA requirement. With all assays completed and showing favorable safety profiles, Argenica is prepared to submit a comprehensive response to the FDA clinical hold, aiming to secure IND approval and advance to a Phase 2b clinical trial targeting acute ischaemic stroke patients.
Key Points
  • ARG-007 (xaranetide) completed all three FDA requested assays with favorable safety profiles.
  • Successfully conducted a GLP-compliant in vitro hERG assay showing no significant inhibition of the hERG cardiac potassium channel.
  • The hERG assay was the final requirement to address the FDA clinical hold for ARG-007 (xaranetide).
  • Completion of the assays positions Argenica to respond to the FDA clinical hold and seek IND approval.
  • Argenica aims to proceed to Phase 2b clinical trial in acute ischaemic stroke patients upon FDA approval.
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.