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.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。