Biohaven (BHVN) said Tuesday the Food and Drug Administration accepted for priority review its new drug application for troriluzole to treat adult patients with spinocerebellar ataxia.
The FDA is expected to decide on the application within six months, Biohaven said, adding that if approved it is prepared to commercialize troriluzole in the US in 2025.
The application submission is based on positive results from a study that showed that oral 200 mg doses of troriluzole met key endpoints of change from baseline in the functional scale for assessing the disease.
Biohaven shares were more than 7% higher in premarket trading.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.