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Investing.com -- Biohaven Pharma (NYSE: BHVN) shares fell sharply by as much as 21% as the company withdrew its marketing authorization application for Dazluma in Europe, intended to treat spinocerebellar ataxia genotype 3 (SCA3). The stock’s downturn followed a brief trading halt due to volatility.
The European Medicines Agency announced that Biohaven Bioscience had retracted its application after the regulatory body had evaluated the submitted information and posed questions to the company. Even after Biohaven responded to the latest round of inquiries, unresolved issues remained, prompting the company to pull its application.
Biohaven’s decision to withdraw came as it plans to gather additional data to support a new active substance status for troriluzole hydrochloride monohydrate, the active ingredient in Dazluma. The company aims to resubmit a new application once the additional data are available.
This setback for Biohaven is significant as Dazluma was targeted at treating SCA3, a genetic disorder that affects the nervous system and leads to difficulties with movement and coordination. The withdrawal indicates a delay in bringing the treatment to market, which likely contributed to investors’ concerns and the subsequent stock price decline.
The company’s letter to the European Medicines Agency indicated a commitment to continuing the development of Dazluma and to address the regulatory body’s concerns through further research. However, the timeline for the generation of new data and the potential submission of a new application remains uncertain.