Why BioHAVEN Stock is more than 15% today today

On Friday news Biohaven (BHVN -15.34%)) As a result of withdrawing the application of the highest investigative drug from important regulators, investors actively traded in stocks. Clinical stage biotechnology was one of the biggest declarations in the industry and the stock price fell by more than 15%on Friday. This was inherently optimistic. that S & P 500 The index was 0.6% higher.

Strategic withdrawal

The news came from the European pharmaceutical agency (EMA, the Pharmaceutical Regulatory Agency of the European Union in 27), not the Biohaven itself. In the statement, the EMA said the company’s subsidiary withdrew its marketing application. Tro Liluszol, as a brand Dazluma. On March 24, A’s agency added.

Biohaven originally applied for that approval for Dazluma at the end of 2023. The surveyed drug aims to suffer rare genes of nerve cells called Spinocerebellar Anyaxia Type 3.

According to the EMA, we provided information about Biohaven’s Dazluma and prepared a series of questions about the company. The agency pointed out that there are some problems that have been alleviated for approval.

If you don’t succeed at first …

Biohaven has not yet made a formal statement about the withdrawal of Dazluma, but sent a letter to the EMA for the reason. The agency says in the letter that Biohaven plans to generate additional data to support new things. Active substance State “state for drugs.

In addition, according to the EMA, the company is trying to submit a new application when such data is created.

Anyway, retreat from regulations is a big blow to investor fraud. Since the European Union is huge and wide, there is one of the largest patients in the jurisdiction of the world.