Telix today announces that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate, has been validated and accepted for review.
Telix Doses First Patient in Phase 3 IPAX-BrIGHT Trial of TLX101-Tx for Recurrent Glioblastoma
Telix today announces that the first patient has been dosed with TLX101-Tx (¹³¹I-iodofalan) in Telix’s pivotal IPAX BrIGHT trial, marking the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, an aggressive form of brain cancer.
Telix and Regeneron Announce Strategic Radiopharma Collaboration
Telix and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN, “Regeneron”) today announce a collaboration to jointly develop and commercialize next generation radiopharmaceutical therapies.
Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px, (Pixclara®, Floretyrosine F 18 or 18F-FET), an investigational PET agent for the imaging of glioma (brain cancer), and has assigned a PDUFA goal date of September 11, 2026.
Telix Strengthens Board with Additional Director Appointments
Telix today announces two additional Non-Executive Director (NED) appointments, effective May 11, 2026, as part of Board expansion and succession planning
Telix Appoints David Gill as Non-Executive Director
Telix today announces the appointment of David Gill as a Non-Executive Director (NED), as part of Board expansion and succession planning. The appointment is effective May 11, 2026. Mr. Gill is expected to be appointed Chair, succeeding Dr. Mark Nelson who will remain on the Board as a NED.