Telix Pharmaceuticals Limited (TLX) generates a steady flow of news related to its radiopharmaceutical pipeline, commercial portfolio, and global operations. As a biopharmaceutical company focused on therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, its announcements often highlight progress in oncology and rare disease programs, regulatory milestones, and commercial performance.
Recent Telix news has covered precision medicine portfolio updates, including Phase 3 data for TLX591-CDx (Illuccix) in China, regulatory interactions for TLX101-CDx (Pixclara) and TLX250-CDx (Zircaix) with the U.S. Food and Drug Administration, and inclusion of TLX250-CDx in international renal imaging guidelines. The company also reports on clinical collaborations, such as its agreement with Varian to explore combining Telix’s theranostic products with external beam radiation therapy.
Investors and clinicians following TLX news can expect updates on clinical trial milestones (for example, first patient dosed in the SOLACE trial for TLX090 or in the BiPASS Phase 3 trial for prostate cancer diagnosis), as well as information on reimbursement and market access developments. Telix has announced CMS Transitional Pass-Through status and a permanent HCPCS code for Gozellix in the United States, along with country-level approvals and launches for Illuccix in Europe and the United Kingdom.
Telix also issues news on financial performance and guidance, such as quarterly revenue updates and full-year revenue outlook, and on participation in major healthcare conferences where management presents the company’s pipeline and commercial strategy. For users tracking TLX, the news stream provides insight into how Telix advances its radiopharmaceutical products from clinical development through regulatory review and commercialization across multiple regions.
Telix Pharmaceuticals (TLX) has begun U.S. commercial availability of Pixclara, its FDA-approved brain cancer imaging drug, with the first patients dosed. Doses were administered at IU Health Neuroscience Center in Indianapolis and University Hospitals Cleveland Medical Center. Manufacturing and pharmacy distribution partner PharmaLogic is supplying finished unit doses to the U.S. market.
Pixclara is used with positron emission tomography (PET) to distinguish recurrent or progressive glioma from treatment-related changes, alongside other diagnostic evaluations, in adults and children one month and older. A Phase 3 registrational study is evaluating potential expansion to diagnosing brain metastases. Label warnings include possible false positive or false negative interpretations and cumulative radiation exposure associated with increased cancer risk.
Telix Pharmaceuticals (TLX) has signed an agreement to merge with ITM Isotope Technologies Munich for upfront consideration of US$1.65 billion on a cash‑free/debt‑free basis.
ITM shareholders are expected to receive about US$1.25 billion in Telix shares, priced at US$11.841 per share and to be delivered as Nasdaq‑listed ADRs after escrow. Telix will assume US$302 million of net debt and there is US$96 million of management equity rollover and transaction expenses payable by the sellers, all subject to closing adjustments. Additional contingent consideration of up to US$700 million is tied to specified FDA approvals and 2030 sales milestones for ITM‑11.
The combined group is expected to generate unaudited pro forma 2026 revenue and income above US$1.3 billion, with positive EBITDA contribution targeted from 2027. On completion, Telix shareholders will own about 76.3% and ITM shareholders 23.7% of Telix. Closing is targeted by the end of FY 2026, subject to Telix shareholder and regulatory approvals and other customary conditions.
Telix (TLX) received U.S. FDA approval for Pixclara, the first FET-PET imaging drug for glioma, on 14 September 2026.
Pixclara (floretyrosine F 18, 18F‑FET) is a radioactive diagnostic drug indicated with PET to differentiate recurrent or progressive glioma from treatment-related change, alongside other evaluations, in adults and pediatric patients from 1 month of age. It is the only FDA‑approved radiopharmaceutical imaging drug for glioma and the first FDA‑approved PET imaging drug for this disease in the U.S., enabling access to guideline‑supported FET‑PET imaging where no approved product was previously available.
Safety was evaluated in 382 glioma patients; adverse reactions ≥0.5% were headache (0.5%), with nausea, injection site reaction, fatigue, and malaise each occurring in <0.5% of patients. The label carries warnings on image misinterpretation risks and cumulative radiation exposure.
Telix Pharmaceuticals (TLX) will present at the Morgan Stanley 24th Annual Global Healthcare Conference on September 14, 2026, and the H.C. Wainwright 28th Annual Global Investment Conference on September 15, 2026, in New York.
Managing Director and Group CEO Dr. Christian Behrenbruch and Kevin Richardson, CEO, Precision Medicine, are scheduled to speak at 9:15 a.m. EDT and 10:30 a.m. EDT respectively. Both sessions will be webcast live and accessible via Telix’s Investor Relations website.
Telix (ASX: TLX, NASDAQ: TLX) has completed enrollment of 350 patients in the Phase 3 BiPASS™ study, evaluating Illuccix® and Gozellix® (68Ga-PSMA-11 PET) combined with MRI for prostate cancer imaging in the pre-biopsy setting in the U.S. and Australia.
BiPASS is described as the first registrational 68Ga-PSMA-PET study in this setting and is designed to assess diagnostic performance, biopsy avoidance, and biopsy targeting versus current practice. Telix has also aligned with the U.S. FDA on an NDA pathway that, if approved, could support reimbursement as a new product and broaden access to 68Ga-PSMA-PET imaging for a substantially larger patient population, potentially building on prior PRIMARY and PRIMARY2 data.
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) has appointed David Gill as Chair of its Board, effective immediately, succeeding interim Chair Dr. Mark Nelson, who remains a Non-Executive Director. Gill joined Telix as a Non-Executive Director in May 2026 as part of Board expansion and succession planning.
According to Telix, Gill brings over 35 years of senior leadership experience in commercial and clinical-stage biopharmaceutical, radiopharmaceutical and medical device companies, including prior CFO or President roles at several publicly traded firms. He also currently serves on the boards of Evolus (NASDAQ: EOLS) and other healthcare companies.
Telix Pharmaceuticals (ASX/NASDAQ: TLX) reported H1 2026 group revenue of US$477 million, up 22% year-over-year, with gross margin rising to 55%. Adjusted EBITDA reached US$52 million (up 146%), supported by strong Precision Medicine sales and a US$40 million non‑refundable upfront payment from a Regeneron collaboration.
Profit after tax was US$38 million versus a US$2 million loss in H1 2025. R&D investment grew to US$124 million, including US$68 million for therapeutics. Telix refinanced its convertible bonds by issuing US$600 million of new bonds due 2031 and ended the half with US$252 million in cash and US$23 million in positive operating cash flow.
Precision Medicine revenue rose 27% with a 65% gross margin, and key pipeline milestones were achieved across Illuccix, Pixclara, Zircaix and late‑stage therapeutics. Telix expects FY 2026 revenue and other income to exceed US$1 billion and has established a Nasdaq at‑the‑market equity facility to issue ADSs at its discretion.
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) will host an in-person Research and Development Day in New York City on Tuesday, September 22, 2026, from 8:30 a.m. to 12:30 p.m. EDT for qualified institutional investors and analysts.
The event will cover Telix’s therapeutic and precision medicine pipeline and recent scientific, clinical and strategic developments, with presentations by senior leadership and external key opinion leaders. Advance registration is required. Telix also plans a Capital Markets Day in Melbourne on November 4, 2026, with further details to follow.
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) will release its financial results for the half-year ended June 30, 2026 on Thursday, August 20, 2026. An investor webcast and conference call are scheduled for 9:00 a.m. AEST that day (7:00 p.m. EDT on Wednesday, August 19, 2026). Participants can register via the provided online link.
According to Telix, the company is a commercial-stage global radiopharmaceutical business focused on targeted theranostics for cancer. Its portfolio includes prostate cancer imaging products Illuccix and Gozellix, and late-stage therapeutic candidates TLX591-Tx, TLX101-Tx and TLX250-Tx in pivotal trials.
Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) reported that results from its Phase 1 ProstACT SELECT study of TLX591-Tx, a PSMA-targeting radio antibody-drug conjugate (rADC) for advanced metastatic castration-resistant prostate cancer (mCRPC), have been published in the peer-reviewed journal Cancers.
The study evaluated use of 68Ga-PSMA-PET imaging (Illuccix) to select patients for TLX591-Tx using a theranostic approach and assessed biodistribution, dosimetry, safety and tolerability. According to Telix, TLX591-Tx showed an intensified dosing schedule, prolonged tumor retention, low salivary gland irradiation, a manageable and predictable safety profile, and indicative efficacy with median radiographic progression-free survival of 8.8 months in evaluable patients, supporting the ongoing Phase 3 ProstACT Global trial.