Biohaven Ltd. (BHVN) Monday said its pivotal study of troriluzole in Spinocerebellar Ataxia (SCA) met its primary goal. In the pre-market trade, the company's shares were rising about 17 percent.
SCA, which has no FDA approved treatments, is a hereditary, progressive disorder that affects the cerebellum and causes loss of muscle coordination, or ataxia.
The study was designed to assess the effectiveness of troriluzole in SCA after 3 years of treatment as measured by the change from baseline in the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA).
SCA patients treated with troriluzole showed a 50 percent-70 percent slower rate of disease progression, or 1.5-2.2 years delay in disease progression over the 3-year study period.
Biohaven plans to submit a new drug application to the Food and Drug Administration for troriluzole for the treatment of SCA, in the fourth quarter.
The application is eligible for a priority review given orphan drug and fast-track designations previously granted by FDA, the company said in a statement.
Biohaven stock had closed at $40.39, down 0.07 percent on Friday. It has traded in the range of $16.48 - $62.21 in the last 1 year.
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