Island Pharmaceuticals secures 7-year US market exclusivity

• The United States Food and Drug Administration granted orphan drug designation to Galidesivir for post-exposure prophylaxis of Marburg virus disease.
• The regulatory milestone provides potential benefits, including fee exemptions and seven years of United States market exclusivity upon approval.
• The designation supports the advancement of the asset as a biodefense countermeasure under the Animal Rule regulatory pathway.

Island Pharmaceuticals (ASX:ILA) secured US FDA Orphan Drug Designation for Galidesivir, granting seven years of market exclusivity upon approval.

The regulatory milestone follows the execution of an expanded research agreement with the United States military earlier this month.

The programme receives exemptions from specific application fees alongside ongoing regulatory assistance throughout the drug development process.

The company stated that the designation strengthens its position before starting dose optimisation initiatives next quarter.

Following the announcement, the Island Pharmaceuticals share price was up at $0.38.

Island operates as an Australian antiviral drug development company focused on infectious diseases with limited treatment options.

The business is concurrently advancing another clinical-stage antiviral programme known as ISLA-101 to address dengue fever.