Delay for Biohaven’s troriluzole NDA
US biopharma Biohaven (NYSE: BHVN) has been told by the US Food and Drug Administration (FDA) that the agency is extending the PDUFA date for the company’s troriluzole new drug application (NDA) for the treatment of spinocerebellar ataxia (SCA) by three months.
This delay will provide time for a full review of Biohaven's recent submissions related to information requests from the FDA. Following the news, shares in the Connecticut company had plunged by 17% from Wednesday to Friday lunchtime.
The FDA also informed Biohaven that it is currently planning to hold an advisory committee meeting to discuss the application, but no date has been scheduled.
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