BUZZ - Biohaven shares surge as FDA reconsiders a drug for treating brain disorders

October 22 - ** Biohaven (BHVN.N) shares rose 43.7% in premarket trading to $16.88

** The U.S. Food and Drug Administration (FDA) has accepted Biohaven’s resubmission of a new drug application for Vyglxia (link) and placed it under review

** The resubmitted application includes new supportive analyses for treating spinocerebellar ataxia, a rare neurodegenerative disorder affecting movement and balance

** Last year, the regulator rejected approval of the therapy (link) due to concerns over study design, potential bias, and data limitations

** The health agency plans to convene an advisory committee meeting to seek input from external stakeholders

** The FDA has set the first quarter of 2027 as the target date for a review decision

** As of the previous trading day's close, the shares were up about 4% for the year

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