** U.S.-listed shares of Australia's Telix Pharmaceuticals TLX.AX, TLX.O fall 7.8% to $17.35
** Late on Sunday, co said the US FDA declined to approve its marketing application for Pixclara, an imaging agent for glioma brain cancer
** TLX said FDA has requested additional clinical evidence to progress the application, stating that the application cannot be approved in its current form
** An imaging agent is a substance used in medical scans to enhance the visibility of internal body structures
** Co said it plans to request a hearing with the FDA to understand the decision and explore ways to supplement their application
** The rejection does not affect the company's financial forecasts for 2025, co said
** Including session move, stock up 8.4% YTD
(Reporting by Kamal Choudhury in Bengaluru)
((Kamal.Choudhury@thomsonreuters.com;))