Biohaven jumps as FDA takes second look at brain disorder drug

By Reuters News

** Shares of drugmaker Biohaven BHVN.N rise 43.7% to $16.88 premarket

** US FDA accepts Biohaven's resubmitted new drug application for Vyglxia for review

** Resubmission includes new positive supportive analyses for treating spinocerebellar ataxia, a rare neurodegenerative disorder that affects movement and balance

** Last year, the health regulator declined to approve the treatment, citing concerns over study design, potential bias, and data limitations

** The health agency plans to hold an advisory committee meeting to obtain input from external stakeholders

** FDA assigns a target review decision date in Q1 2027

** As of last close, stock up ~4% YTD

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