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Biohaven issued a press release on May 14, 2025, “announc[ing] that the Division of Neurology 1 within FDA’s Office of Neuroscience informed the Company that they are extending the PDUFA date for the troriluzole new drug application (NDA) for the treatment of spinocerebellar ataxia (SCA) by three months to provide time for a full review of Biohaven’s recent submissions related to information requests from the FDA.” The press release further stated that “[t]he Division also informed Biohaven that it is currently planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled.”
Following this news, Biohaven’s stock price fell over 19% on May 15, 2025.