The US Food and Drug Administration has accepted Telix Pharmaceuticals' (ASX:TLX) Biologics License Application for its investigational kidney cancer imaging agent TLX250-CDx, and granted a priority review that would pave the way for a commercial launch within the year, according to a Wednesday filing with the Australian bourse.
The imaging agent has been given a Prescription Drug User Fee Act (PDUFA) date of Aug. 27. A PDUFA date provides an estimated timeline of when a decision on a drug application would be made.
TLX250-CDx is said to be the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma, a form of kidney cancer, per the filing.
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。