Ionis Pharmaceuticals Aktie 30877188 / US4622221004
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23.03.2026 13:18:09
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Ionis: FDA Accepts For Priority Review NDA For Zilganersen
(RTTNews) - Ionis Pharmaceuticals (IONS) announced that the FDA has accepted for Priority Review the New Drug Application for zilganersen, an investigational RNA-targeted medicine for Alexander disease. The FDA has set a PDUFA target action date of September 22, 2026. The NDA and Priority Review designation were based on results from the pivotal study of zilganersen in children and adults living with AxD.
Brett Monia, CEO, Ionis, said: "Priority Review designation underscores the urgent need for treatment options and will enable us to bring zilganersen to patients as quickly as possible. If approved, zilganersen will be the first and only treatment for Alexander disease, marking a breakthrough for patients."
In pre-market trading on NasdaqGS, Ionis Pharma shares are up 2.8 percent to $72.99.
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