Ascendis Pharma (ASND) said Monday its new drug application for the TransCon CNP candidate to treat children with achondroplasia, a genetic condition, was accepted by the US Food and Drug Administration for priority review.
The FDA set a prescription drug user fee act date of November 30 to close the review process, according to a statement.
The US regulator is not currently planning to conduct an advisory committee meeting to discuss the application, the company said.
Shares were up 5.4% in recent trading.
Price: 171.52, Change: +8.68, Percent Change: +5.33
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。