News & Views - Page 4 of 52 - Telix Pharmaceuticals Limited

FDA Accepts NDA for TLX101-Px (Pixclara®)

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

Q1 2026: Strong Revenue Growth and Therapeutics Pipeline Advancement

Telix provides a market update on its commercial and operational performance for the quarter ended March 31, 2026 (Q1 2026).

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.

You’re Not Alone

Liz Leff was diagnosed with clear cell renal cell carcinoma (ccRCC) in 2014. The experience shaped everything that followed, including a career in patient advocacy that eventually brought her to Telix.

Live Your Life

Maggie Valdes Butera’s husband Brandon was diagnosed with kidney cancer in 2021 at the age of 26. He passed away in 2024. We spoke to Maggie about their journey together, the diagnostic delays that shaped it, and why she continues to advocate for research that could give future patients more time.

Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate

Telix today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®, Floretyrosine F 18 or 18F-FET), an investigational PET imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.

ProstACT Global Phase 3 Study (Part 1) Achieves Primary Objectives

Telix today announces that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed.

Investor Education Webinar: The Future of Prostate Imaging: What do physicians want?

Telix invites investors to join a webinar with key opinion leaders to discuss a physician’s perspective on innovations in PSMA-PET/CT imaging for prostate cancer.

Telix Joins Forces with University Hospital Essen on PROMISE-PET: Optimizing Patient Management through AI-enabled PSMA-PET Imaging

Telix today announces a research collaboration with University Hospital Essen on the PROMISE-PET registry, defining the potential prognostic value of PSMA-PET imaging through artificial intelligence (AI).