FDA Grants Priority Review to Ionis' NDA for Alexander Disease Drug Treatment

Ionis Pharmaceuticals has received FDA priority review for its new drug application for zilganersen, a treatment for Alexander disease. The regulatory body has set a target action date of September 22, 2026. If approved, zilganersen would be Ionis' third wholly owned approved drug and mark its commercial entry into the neurology space. The FDA's priority review was based on positive phase III data showing the treatment's ability to stabilize gait speed and slow disease progression.