Biohaven (BHVN) has withdrawn its application for a marketing authorization of Dazluma to treat spinocerebellar ataxia genotype 3, an inherited brain disorder, the European Medicines Agency said Friday.
Biohaven shares were down more than 11% in recent trading.
The EMA said the application was withdrawn after the regulator evaluated the information from the firm and prepared questions.
"Based on the review of the data and the company's response to the Agency's questions, at the time of the withdrawal, the Agency had some concerns, and its provisional opinion was that Dazluma could not have been authorized for the treatment of spinocerebellar ataxia," the regulator said.
The EMA also said it considered that no conclusions could be drawn as the findings of the main study did not show that Dazluma was more effective than placebo for the treatment of spinocerebellar ataxia.
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