Island Pharmaceuticals (ASX:ILA) secured an Orphan Drug Designation from the US Food and Drug Administration (FDA) for its antiviral candidate Galidesivir as a post-exposure prophylaxis for Marburg virus disease, according to a Wednesday filing with the Australian bourse.

The designation offers regulatory and commercial benefits, including up to seven years of US market exclusivity if approved, along with fee waivers and increased FDA support, per the filing.

The company also noted recent progress, including an expanded Cooperative Research and Development Agreement with the US Army Medical Research Institute of Infectious Diseases, securing a non-human primate supply for upcoming dose-optimization studies, and initiating GMP manufacturing.

The company said that preparations for pivotal studies are ongoing, with the next development phase expected to start in the next quarter, the filing added.