NasdaqGS:IONSBiotechs
Will Priority FDA Review of Zilganersen and Tryngolza Pricing Shift Ionis Pharmaceuticals' (IONS) Narrative
Ionis Pharmaceuticals recently announced that the FDA accepted for Priority Review its New Drug Application for zilganersen, an RNA-targeted therapy for Alexander disease, with a Prescription Drug User Fee Act target action date set for September 22, 2026, following pivotal data showing clinically meaningful stabilization of gait and favorable safety.
An interesting angle for investors is that zilganersen carries multiple expedited and rare-disease designations, highlighting regulatory...