Island Pharmaceuticals (ASX:ILA) has taken a step forward in the development of its antiviral candidate galidesivir, securing a strategic partnership with the Texas Biomedical Research Institute, one of the world’s most advanced infectious disease centres and a critical player in high-containment pathogen research.
The agreement strengthens Island’s push to progress galidesivir through the FDA’s Animal Rule pathway, a specialised regulatory mechanism for countermeasures targeting lethal viral threats without available treatments.
The Master Service Agreement (MSA) gives Island Pharmaceuticals access to Texas Biomed’s unique capabilities, including its biosafety level 4 (BSL-4) laboratory and its federally designated National Primate Research Center. Texas Biomed is one of only four BSL-4 facilities in the United States, and the only independent, non-profit institute offering both BSL-4 containment and primate research capacity under one roof.
Island Pharmaceuticals said the partnership represents a significant leap forward in positioning galidesivir as a potential antiviral countermeasure for high-consequence pathogens such as Marburg virus, for which no approved treatments exist. The decision follows recent positive engagement with the FDA, confirming that galidesivir is eligible for the Animal Rule pathway and, if approved, may qualify for a Priority Review Voucher. Further FDA feedback is expected in early January 2026, informing the design of a planned clinical program slated for the first quarter of 2026, pending regulatory approval.
Island CEO and Managing Director Dr David Foster said the agreement with Texas Biomed provides the company with critical optionality as it finalises its development strategy.
“Securing an agreement with Texas Biomed represents an important strategic step in the development of galidesivir,” he said. “Texas Biomed’s world-class expertise in high-containment infectious disease research, including deep experience conducting non-human primate studies under rigorous regulatory standards, provides Island with an optimal potential partner to progress our antiviral candidate toward FDA approval.”
Foster noted that the company continues to negotiate with other potential research partners as part of its broader effort to identify best-in-class collaborators for galidesivir’s next phase of development. In parallel, Island remains focused on aligning its antiviral pipeline with US government preparedness priorities, targeting viral threats that pose both significant public health risks and national security concerns.