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Argenica Therapeutics Limited (ASX:AGN)

ALERT: Price-sensitive ASX Announcement for AGN
Current share price for AGN : $0.105 -0.03 (-22.22%)+
Announcement
Release
21 May 2026 9:01AM
Price at Release
$0.135
Full Release
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Summary
Argenica Therapeutics Limited announced the successful completion of a GLP-compliant in vitro Mouse Lymphoma Assay, which was requested by the FDA to address a clinical hold on their investigational new drug (IND) application for ARG-007. The assay showed no evidence of genotoxicity, addressing the FDA’s concerns about potential genetic mutation or chromosomal aberrations. This study represents the second of three FDA-requested assays, following positive results from a Tenecteplase assay. The final assay, a GLP hERG cardiac safety assay, is currently in progress. Completion of all three assays will allow Argenica to submit a comprehensive response to the FDA and seek approval to conduct a Phase 2b trial in the United States. The company is also pursuing regulatory approvals for trial sites in Australia.
Key Points
  • Successful completion of the Mouse Lymphoma Assay under GLP conditions.
  • No evidence of genotoxicity in ARG-007, addressing FDA requirements.
  • Second of three FDA-requested assays completed.
  • Final GLP hERG cardiac safety assay in progress.
  • Full response to FDA clinical hold to be compiled after assay completion.
  • Aim to conduct Phase 2b trial in the United States upon FDA approval.
  • Regulatory approvals in process for Australian trial sites.
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.