FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review

MELBOURNE, Australia and INDIANAPOLIS, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET¹ imaging agent TLX250-CDx (Zircaix®², ⁸⁹Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA³ date of 27 August 2025, paving the way for a U.S. commercial launch in 2025.