Ionis announces zilganersen New Drug Application for Alexander disease (AxD) accepted by FDA for Priority Review
Ionis Pharmaceuticals, Inc. (IONS)
Last ionis pharmaceuticals, inc. earnings: 2/26 07:00 am
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Source: Business Wire
– PDUFA date set for September 22, 2026 – CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for zilganersen, an investigational RNA-targeted medicine for Alexander disease (AxD), a rare, progressive and often fatal neurological condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of September 22, 2026."Alexander disease is a devastating condition, commonly resulting in progressive motor and cognitive dysfunction, loss of independence and is often fatal. There are no approved disease-modifying treatments, underscoring the significant unmet need in this community,” said Brett Monia, Ph.D., chief executive officer, Ionis. “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, zilganerse
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- 2/25/26 - Miss
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- 3/24/26 - Form 144/A
- 3/23/26 - Form 4
- 3/19/26 - Form 144
- IONS's page on the SEC website