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Ionis Pharmaceuticals Receives FDA Breakthrough Therapy Designation for Zilganersen, Plans 2026 NDA Submission
ByAinvest
Wednesday, Dec 3, 2025 3:49 am ET1min read
Ionis Pharmaceuticals (IONS) received FDA breakthrough therapy designation for zilganersen to treat Alexander disease. The company plans to submit a New Drug Application in early 2026 and is preparing an Expanded Access Program in the US. Ionis Pharmaceuticals is a leader in antisense technology with a broad pipeline targeting cardiovascular, metabolic, neurological, and rare diseases.
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