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Island Pharmaceuticals LtdASX: ILA

FDA confirms response timing for Galidesivir

Oct 21, 2025 at 10:54 PM EDT · Issued by Island Pharmaceuticals Ltd

Filed with ASX · Oct 21, 2025 at 10:54 PM EDT

On 6ix: 6ix.com/news/fda-confirms-response-timing-for-galidesivir

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Story so far

  • FDA meeting request lodged for GalidesivirSep 1, 2025
  • Completion of Galidesivir transactionJul 31, 2025
  • Portfolio expansion achieved with acquisition of GalidesivirJul 9, 2025

Earlier from Island Pharmaceuticals

  • US FDA Type C meeting briefing document submittedSep 28, 2025
  • FDA Meeting request grantedSep 18, 2025
  • FDA meeting request lodged for GalidesivirAug 31, 2025
  • Preliminary Final ReportAug 28, 2025
  • Options exercise from existing substantial shareholderAug 11, 2025

Later from Island Pharmaceuticals

  • FDA agrees Animal Rule pathway and PRV eligibilityNov 16, 2025
  • Island engages advisers to advance biodefence strategyNov 19, 2025
  • Coalition acceptance to advance US procurement & stockpilingNov 23, 2025
  • Options exercised raises $1millionDec 2, 2025
  • Additional FDA Submission completed for GalidesivirDec 3, 2025
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