Core Viewpoint - Biohaven's withdrawal of its application for the investigational drug Dazluma from the European Medicines Agency led to a significant decline in its stock price, dropping over 15% despite a generally bullish market on that day [1][2]. Group 1: Company Actions - Biohaven's subsidiary withdrew its application for marketing authorization for Dazluma on March 24, as announced by the European Medicines Agency [2]. - The company originally applied for authorization for Dazluma at the end of 2023, targeting spinocerebellar ataxia type 3, a rare genetic nerve cell affliction [3]. - Biohaven indicated in a letter to the EMA that it plans to generate additional data to support a new application for the drug once the data is available [4]. Group 2: Regulatory Context - The EMA had prepared a series of questions regarding Dazluma and noted several issues that hindered its approval [3]. - The withdrawal from a regulatory submission is viewed as a significant setback for investor confidence, especially given the large patient pool in the European Union [4].
Why Biohaven Stock Plummeted by More Than 15% Today