By Colin Kellaher
Biohaven has won Food and Drug Administration priority review for its application seeking approval of troriluzole for adults with spinocerebellar ataxia, a group of rare, genetic neurological disorders.
Biohaven on Tuesday said a green light would make troriluzole the first and only FDA-approved treatment for the life-threatening disorder.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Biohaven, a New Haven, Conn., biopharmaceutical company, said it expects an FDA decision in the third quarter, adding that it is prepared to commercialize troriluzole in the U.S. this year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 11, 2025 07:51 ET (12:51 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
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。