Ionis Pharmaceuticals' Zilganersen Gets FDA Fast Track for Treating Rare Neurological Disorder Alexander Disease
Portfolio Pulse from Benzinga Newsdesk
Ionis Pharmaceuticals' drug zilganersen has received FDA Fast Track designation for treating Alexander disease, a rare neurological disorder. This designation aims to expedite the drug's development and review process. Topline data from the pivotal study is expected in the second half of 2025.
October 01, 2024 | 11:04 am
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Ionis Pharmaceuticals' zilganersen has been granted FDA Fast Track designation for Alexander disease, potentially expediting its development and review. This could lead to the first approved treatment for this rare disorder, with pivotal study data expected in 2025.
The FDA Fast Track designation is a positive regulatory development for Ionis Pharmaceuticals, as it facilitates the drug's development and review process. This increases the likelihood of zilganersen becoming the first approved treatment for Alexander disease, which could significantly impact Ionis' market position and stock price positively.
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