Additional FDA Submission completed for Galidesivir
Filed with ASX · · 2 pages · English
MELBOURNE Australia, 4 December 2025: Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to confirm it has submitted its responses to previous guidance provided by the US Food & Drug Administration (FDA) on the clinical development program for Galidesivir. It follows recent confirmation by the FDA that developing a countermeasure
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Story so far
Earlier from Island Pharmaceuticals
- Options exercised raises $1million
- Coalition acceptance to advance US procurement & stockpiling
- Island engages advisers to advance biodefence strategy
- FDA agrees Animal Rule pathway and PRV eligibility
- FDA confirms response timing for Galidesivir
Later from Island Pharmaceuticals
- Island expands Galidesivir IP with US Patent Grant
- Agreement with Texas Biomed for Galidesivir Program
- Ongoing engagement with the US FDA
- US Patent Granted for Galidesivir in filoviridae viruses
- Quarterly Appendix 4C and Activities Report
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