Telix reports Third Quarter 2026 Financial Performance
Melbourne (Australia) and Indianapolis, IN (U.S.) | October 21, 2026
Telix provides a financial update on its commercial and operational performance for the quarter ended September 30, 2026 (Q3 2026).
Q3 2026 Highlights1
- Group revenue of US$245 million increased 19% over the prior corresponding quarter (Q3 2025) driven by continued strong demand for the commercial portfolio, in line with expectations. September sales drove a higher quarterly exit rate indicating continued strength in underlying demand for Telix’s PSMA products.
- Precision Medicine revenue of US$201 million, increased 30% over the prior corresponding quarter, driven by both Gozellix® and Illuccix®2. Telix’s commercial PSMA-PET imaging3 portfolio continued to strengthen its market position, driven by strong demand for our clinically differentiated products.
- U.S. Food and Drug Administration (FDA) approved Pixclara®4 for glioma imaging, marking a significant milestone and establishing the first approved imaging agent for this indication in the U.S.5. The first commercial doses were administered in September 20266.
- BiPASS®, a Phase 3 study evaluating pre-biopsy prostate cancer detection, completed enrollment7, with the FDA supporting an NDA pathway and granting Fast Track Designation8.
- Telix announced a merger with Isotope Technologies Munich SE (ITM). The merger creates a leading radiopharmaceutical platform with one of the industry’s broadest therapeutics pipelines, supported by best-in-class isotope production, manufacturing, and supply chain capabilities9.
- Telix reaffirmed that FY 2026 revenue and other income is expected to be in excess of US$1 billion, with revenue tracking in line with upper end of FY 2026 guidance of US$950 million to US$970 million plus US$40 million of other income. The Company has also revised its FY 2026 R&D expenditure guidance range to US$240 million to US$260 million.
Q3 2026 Revenue
Executive Commentary
Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, “Demand for both Gozellix and Illuccix remained strong during the quarter, with U.S. dose volumes increasing 1% quarter-over-quarter, in line with our expectations and reflecting expected summer seasonality. We are pleased by the strong September exit run rate, supporting our confidence in delivering over 25% Precision Medicine revenue growth in 2026. We achieved an important milestone with the FDA approval of Pixclara, expanding our commercial portfolio, establishing a presence in neuro-oncology and further diversifying our revenue base. During the quarter, we announced a transformative merger with ITM, creating a leading vertically integrated radiopharmaceutical company with one of the industry’s broadest therapeutic pipelines and expanded isotope production and global manufacturing capabilities. This is aligned with our long-term growth strategy reinforcing our ability to reliably serve patients at scale.”
Therapeutics Business Unit
- TLX591-Tx (177Lu rosopatamab tetraxetan): Following FDA review and alignment of the Part 1 safety data, Telix is finalizing its IND amendment to the FDA to support progression to Part 2 of the ProstACT Global Phase 3 study in the U.S.12. Outside the U.S., Part 2 of the global study continues to enroll patients across seven countries: Australia, New Zealand, Canada, Türkiye, the UK, Singapore, and South Korea. Regulatory approvals have also been obtained to proceed in China and Japan13.
- TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA): OPTIMAL-PSMA14, a Phase 2 study evaluating TLX597-Tx in metastatic androgen pathway modulator-resistant (mAPMR) prostate cancer15, completed enrollment of 120 patients16. A data readout is expected in the first half of 2027. OPTIMAL-e17, a Phase 2 study evaluating TLX597-Tx in metastatic androgen pathway modulator-naive or -sensitive (mAPMN/S) prostate cancer18, continues to demonstrate strong enrollment momentum.
- TLX250-Tx (177Lu girentuximab tetraxetan): Continued enrollment of patients in LUTEON19, a pivotal trial of TLX250-Tx in advanced clear cell Renal Cell Carcinoma (ccRCC). The trial is evaluating the safety and efficacy of TLX250-Tx compared with the investigator’s choice of monotherapy consistent with standard of care.
- TLX101-Tx (iodofalan 131I): Following full enrollment of the first cohort in Part 1 of the Phase 3 IPAX BrIGHT study20, an IND amendment was filed with the FDA to support expansion of the trial into Part 1b in the U.S. IPAX-221, a Phase 1 study of TLX101-Tx in patients with newly diagnosed glioblastoma met its primary endpoint, establishing a maximum tolerated dose (MTD) of two 5 GBq cycles in combination with standard of care. No dose-limiting toxicities were observed, supporting advancement of IPAX-2 to Phase 222.
Precision Medicine Business Unit
68Ga-PSMA-11 for prostate cancer imaging:
- BiPASS®, a Phase 3 study of 68Ga-PSMA-11 PET in combination with MRI for the diagnosis of prostate cancer in the pre-biopsy setting, completed enrollment of 350 patients. Rapid enrollment underscores the unmet need for a minimally invasive option for prostate cancer diagnosis. The study builds on the clinical foundation established by the PRIMARY23 and PRIMARY224 studies and is intended to support regulatory submissions. The FDA has supported an NDA pathway that could facilitate reimbursement and granted Fast Track Designation, which may enable an expedited review.
- With enrollment complete in the Phase 3 registrational study of TLX591-Px (Illuccix) in Japan25, Telix is preparing for NDA submission and potential market entry. A Conditional Approval is currently under review by Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and is expected to facilitate an expedited review process.
TLX101-Px (floretyrosine F 18) for brain cancer imaging:
- Telix’s Marketing Authorization Application (MAA) for Pixlumi®26 in Europe remains under review.
- Following the FDA clearance of the IND application, Telix is advancing a Phase 3 registrational study to support expansion of the Pixclara label for the diagnosis of brain metastases.
TLX250-Px, Zircaix®27 (89Zr-girentuximab senvedoxam) for kidney cancer imaging:
- Following receipt of the corrected Complete Response Letter (CRL), Telix is finalizing its Biologics License Application (BLA) resubmission package, addressing the remaining third-party manufacturing observations. Resubmission to the FDA is planned in the near term and remains a top priority for the Company in 2026.
Telix Manufacturing Solutions (TMS)
- Through RLS, Telix has established a growing network of micro-pharmacy sites, known as UroOncRxTM, providing urologists with onsite access to our imaging agents, particularly in underserved and remote markets. Multiple sites are now operational and dispensing product, further strengthening our radiopharmacy infrastructure and expanding patient access.
- ARTMS, a Telix company, has secured contracts for 50 QUANTM® Irradiation Systems (QIS®) globally, achieving a key commercial milestone and reflecting continued demand for its isotope production technology. Telix has also placed an order to purchase multiple cyclotrons from Ion Beam Application (IBA) where each cyclotron will be equipped with QIS® technology.
- Telix announced a collaboration with Ekalia28, a joint venture between IBA (Ion Beam Applications S.A., EURONEXT) and Framatome, to advance scalable U.S. production of astatine-211 (211At), an alpha-emitting radioisotope being investigated for targeted alpha therapy. The first IBA alpha-beam cyclotron installation at Telix’s RLS Radiopharmacies site in Trevose, near Philadelphia (PA) is intended to establish a reproducible production model, with the potential for further rollout across the RLS network as demand develops. The collaboration secures long-term, priority isotope access for Telix’s alpha therapy pipeline, while also supporting third-party academic and industry programs.
Corporate Updates
- Telix announced a transformational merger with ITM, the world’s leading supplier of therapeutic radioisotopes, reinforcing its long-term strategy as a vertically integrated radiopharmaceutical company and further strengthening one of the industry’s broadest therapeutic pipelines. ITM brings a complementary late-stage portfolio led by ITM-11 (177Lu-edotreotide) for gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as industry-leading isotope capabilities anchored by the only globally scaled commercial-grade 177Lu production platform. The transaction includes upfront consideration of US$1.65 billion on a cash-free, debt-free basis, with ITM shareholders expected to receive approximately US$1.25 billion in Telix shares released as ADRs. Additional contingent consideration of up to US$700 million may be paid upon achievement of future regulatory approvals and commercial sales milestones for ITM-11. The transaction remains subject to Telix shareholder approval and customary closing conditions. A General Meeting of Shareholders is expected to be held on December 1, 2026 (AEDT).
- Mr. David Gill was appointed Chair of the Board on September 1, 202629. Mr. Gill is a life sciences executive with more than 35 years of experience in biopharma, radiopharmaceuticals and medical devices. He has held senior leadership positions, including President, Chief Operating Officer and Chief Financial Officer roles at multiple public companies, and brings extensive expertise in capital markets, governance, business scaling and corporate strategy. He currently serves on the boards of several healthcare companies and holds degrees from Wake Forest University and Emory University.
- Mr. Marcin Firek will join Telix as Company Secretary, effective October 21, 2026. Mr. Firek brings extensive experience in corporate governance, legal affairs, risk management and public company administration, including for dual-listed Australian and U.S. companies.
