Biohaven Shares Rise About 25% After FDA Accepts Resubmission
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Biohaven Ltd. shares closed about 25% higher Thursday, Oct. 22, after the company disclosed that the U.S. Food and Drug Administration had accepted its resubmitted application for Vyglxia (troriluzole), an investigational treatment for spinocerebellar ataxia. The FDA set a user-fee goal date in the first quarter of 2027 and plans to convene its Peripheral and Central Nervous System Advisory Committee. No meeting date has been announced. The resubmission includes new supportive analyses. Evidence had not established troriluzole’s effectiveness for spinocerebellar ataxia, and Study 206-RWE did not qualify as an adequate, well-controlled investigation.
Source: TokenPost
