TLX News & Events

Telix Pharmaceuticals announced that the first patient has been dosed with TLX101-Tx 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. The patient was dosed at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. IPAX BrIGHT is assessing the safety and efficacy of TLX101-Tx in combination with chemotherapy, compared to chemotherapy alone. The global, multicenter, open-label study will enroll patients with radiographically confirmed recurrent glioblastoma at first recurrence. Professor Gan, Director of Cancer Clinical Trials at Austin Health, said, "Based on the prior safety profile and early efficacy data for TLX101-Tx in the IPAX-1 and IPAX-Linz studies, I am pleased to continue to explore this therapeutic modality in the first radiopharmaceutical pivotal trial in recurrent glioblastoma, where there are currently few effective treatment options."

Telix Pharmaceuticals (TLX) and Regeneron Pharmaceuticals (REGN) announce a collaboration to jointly develop and commercialize next generation radiopharmaceutical therapies. The collaboration combines Telix's radiopharmaceutical development platform, global manufacturing capabilities and supply chain infrastructure with Regeneron's extensive biologics expertise, including bispecific antibody discovery. The collaboration will include multiple solid tumor targets from Regeneron's portfolio of antibodies, generated from VelocImmune mice. With a shared commitment to precision oncology, the parties also plan to develop radio-diagnostics to support patient selection and treatment response assessment. Under the terms of the agreement, Telix will receive an upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform for four initial therapeutic programs, with Regeneron having the option to expand to include four additional programs with additional upfront payments. Telix and Regeneron will share equally in the global commercialization costs and potential profits, with Telix retaining the option to co-promote certain potential products. Should Telix opt-out of the co-funding model for a particular program, it is instead eligible to receive up to $535M in development and commercial milestones, plus low double-digit royalites on future net sales, for that program. Telix and Regeneron will also jointly develop diagnostic assets, with Telix leading commercialization and Regeneron receiving a set percentage of profits.

Telix Pharmaceuticals up 11% to $11.70 after collaboration with Regeneron

Telix Pharmaceuticals announces that the United States Food and Drug Administration has accepted the company's resubmitted New Drug Application for TLX101-Px, an investigational PET agent for the imaging of glioma, and has assigned a PDUFA goal date of September 11, 2026. The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines - including NCCN Guidelines - and TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA. "There remains a critical unmet need in improving our ability to image residual glioma after treatment," said Thomas Hope, MD, Vice Chair, Department of Radiology and Biomedical Imaging, University of California, San Francisco. "We have worked with Telix for the last three years to help leverage our clinical data to help make FET-PET available to patients in the United States." Telix's FY 2026 financial guidance does not include any revenue contribution from TLX101-Px.