Biohaven Shares Jump 25% as FDA Accepts Resubmitted Vyglxia Application for Rare Disease Drug

Biohaven said Thursday that the FDA has accepted its resubmitted application for Vyglxia, a treatment for spinocerebellar ataxia, and will convene an expert panel to review the drug, with a new verdict expected in the first quarter of next year. The news sent the company's shares up about 25%. The FDA formally rejected Vyglxia last November, finding the company's key trial unconvincing in part because of its design, despite findings suggesting the drug might slow disease progression by as much as 70%. European regulators also raised questions about supportive evidence, prompting Biohaven to withdraw its application there. Biohaven resubmitted the application with "new positive supportive analyses," according to a regulatory filing. If approved, Vyglxia could be the first marketed medicine for the condition, with some analysts predicting more than $1 billion in annual sales. TD Cowen analyst Tyler Van Buren wrote that scheduling an advisory committee meeting "substantially increases the probability of approval."