FDA Grants Priority Tag to Ionis' NDA for Alexander Disease Drug

Key Takeaways Ionis Pharmaceuticals secures FDA priority review for zilganersen to treat rare Alexander disease.FDA grants priority review as a phase III study shows significant stabilization in patients' gait speed. IONS said the FDA set a target action date of Sept. 22, 2026, for the NDA decision.Ionis Pharmaceuticals (IONS) announced that the FDA has granted priority review to its new drug application (NDA) seeking approval for zilganersen for the treatment of patients with Alexander disease (AxD), a rar ...