Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.
Island Pharmaceuticals has accelerated its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals, adding a clinically advanced asset with significant US government backing and a promising regulatory pathway.
Island Pharmaceuticals has raised $3.6 million through a strategic share placement to advance its lead antiviral drug ISLA-101’s clinical development and broaden its asset portfolio ahead of pivotal Phase 2a/b trial results.
Island Pharmaceuticals has successfully completed patient dosing in the Phase 2b therapeutic arm of its PROTECT clinical trial for ISLA-101, targeting dengue fever treatment. High-level results are expected within two months, potentially advancing a significant antiviral candidate.