Ionis receives U.S. FDA Breakthrough Therapy designation for zilganersen for Alexander disease (AxD)
Ionis Pharmaceuticals, Inc. (IONS)
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Source: Business Wire
– First and only investigational medicine for this rare, often fatal neurological condition –– On track to submit new drug application (NDA) in Q1 2026 – CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to zilganersen for the treatment of Alexander disease (AxD), a rare, progressive and often fatal neurological condition. Over time, it can lead to loss of mobility and independence, along with difficulties walking, speaking, swallowing and breathing. There are currently no approved disease-modifying treatments for AxD. Breakthrough Therapy designation is intended to expedite the review of medicines that treat a serious or life-threatening condition and have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies.“People living with Alexander disease have gone far too long without a treatme
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IONS
Earnings
- 10/29/25 - Beat
IONS
Sec Filings
- 12/3/25 - Form 4
- 12/1/25 - Form 144/A
- 12/1/25 - Form 144
- IONS's page on the SEC website