Telix Pharmaceuticals (ASX:TLX) said the US Food and Drug Administration (FDA) ruled that its New Drug Application for TLX101-CDx, an investigational agent for the imaging of glioma, cannot be approved in its current form, according to a Monday filing with the Australian bourse.
Glioma is a rare and life-threatening type of brain cancer.
In its complete response letter, the FDA stated further confirmatory clinical evidence is necessary to proceed with the application, the filing said.
The company plans to request a hearing with the FDA to review the basis for the decision, per the filing.
Telix Pharmaceuticals shares were down 7% in morning trade on Monday.
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。