Australian antiviral developer Island Pharmaceuticals (ASX: ILA) has secured a master service agreement with Texas Biomedical Research Institute, a leading US biosafety level 4 research facility.
Texas Biomed, the only independent, non-profit infectious disease institute in the US with integrated National Primate Research Centre capabilities, will provide Island with potential non-human primate study support to advance its antiviral candidate Galidesivir under the FDA’s Animal Rule pathway.
The agreement follows recent FDA engagement confirming Animal Rule eligibility and priority review voucher potential post-approval, with further guidance expected in early January 2026 to inform a planned Q1 2026 clinical program.
CEO Dr David Foster said the MSA "represents a strategic step in Galidesivir's development, leveraging Texas Biomed’s unique BSL-4 infrastructure and regulatory expertise to support potential FDA approval."
Island continues to explore additional partnerships while aligning its program with US government preparedness priorities for high-consequence viral threats.
At the time of reporting, Island Pharmaceuticals' share price was $0.48.