Island Pharmaceuticals Secures $9M as US FDA Confirms Galidesivir Development Pathway
Australian biotech company Island Pharmaceuticals (ASX: ILA) announced it has raised A$9 million in new funding to advance its antiviral candidate galidesivir along a defined US Food and Drug Administration (FDA) development pathway under the specialised Animal Rule, which allows approval based on animal efficacy data for high consequence pathogens. The FDA’s confirmation of the regulatory route and clear development steps significantly derisks the program and positions the company to progress towards pivotal studies and potential inclusion in strategic biodefence stockpiles, while also unlocking eligibility for a valuable Priority Review Voucher upon approval. 
Island Pharmaceuticals Secures $9M as US FDA Confirms Galidesivir Development Pathway