Welcome to our dedicated page for Telix Pharmaceuticals ADR news (Ticker: TLX), a resource for investors and traders seeking the latest updates and insights on Telix Pharmaceuticals ADR stock.
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 (TLX) announced that the FDA accepted its resubmitted NDA for TLX101-Px (Pixclara®, 18F-FET) for imaging glioma and set a PDUFA goal date of September 11, 2026. The agent has FDA Orphan Drug and Fast Track designations and is recommended in international guidelines for glioma imaging.
Telix said TLX101-Px aims to help distinguish tumor progression from treatment-related changes; FY2026 guidance excludes any revenue from TLX101-Px.
Telix (ASX/NASDAQ: TLX) announced two Non-Executive Director appointments effective May 11, 2026: Maria Rivas, MD, and William (Bill) Jellison, as part of Board expansion and succession planning. The hires add U.S. public company governance, late-stage clinical and commercial leadership, and corporate finance oversight to the Board.
The company said the appointments complement a recent director addition and support Telix’s evolution as a dual-listed, global commercial-stage biopharmaceutical company.
Telix (TLX) reported Q1 2026 group revenue of US$230 million, up 24% year-over-year and 11% sequentially, driven by Precision Medicine sales. The company reaffirmed FY2026 revenue guidance of US$950–970 million and R&D guidance of US$200–240 million.
Key clinical updates: ProstACT Part 1 met safety and dosimetry goals; NDA/MAA submissions and regulatory interactions progressed for multiple candidates across the U.S., Europe and China.
Telix (ASX/NASDAQ: TLX) announced the appointment of David Gill as a Non-Executive Director, effective May 11, 2026, as part of Board expansion and succession planning.
Mr. Gill, a life sciences executive with over 35 years of senior management and financial leadership experience, is expected to be appointed Chair in due course, succeeding Dr. Mark Nelson, who will remain on the Board as a NED.
Mr. Gill's background includes CFO/President roles at multiple public companies, board roles in U.S. life sciences firms, and degrees from Wake Forest and Emory.
Telix (ASX: TLX, NASDAQ: TLX) resubmitted a New Drug Application to the U.S. FDA for TLX101-Px (Pixclara®, 18F-FET) to image recurrent or progressive glioma in adults and pediatric patients.
The resubmission includes additional data and statistical analysis requested after a prior Complete Response Letter. TLX101-Px holds Orphan Drug and Fast Track designations and addresses an unmet need for targeted amino acid PET imaging in the U.S.
Telix (ASX: TLX, NASDAQ: TLX) announced that Part 1 of the ProstACT Global Phase 3 safety and dosimetry lead-in for TLX591-Tx met primary objectives, showing acceptable safety, predictable biodistribution and dosimetry, and no new safety signals. 36 patients were dosed across three combination cohorts; radiation exposure remained below established limits and lesion uptake was observed across cohorts.
Telix has advanced the trial into Part 2 in jurisdictions with approvals and will present Part 1 data to the FDA to seek an IND amendment.
Telix (ASX: TLX, NASDAQ: TLX) invites investors to an educational webinar titled The Future of Prostate Imaging: What do physicians want? featuring KOLs discussing PSMA-PET/CT innovations for prostate cancer.
The webcast is scheduled EST: Wednesday March 4, 2026 at 5:30 p.m.; AEDT: Thursday March 5, 2026 at 9:30 a.m. The event will run approximately one hour and requires registration via the company's webcast link.
Telix (ASX: TLX, NASDAQ: TLX) announced a research collaboration with University Hospital Essen to join the PROMISE-PET registry and develop AI-based prognostic models using 68Ga-PSMA-11 PET imaging and Telix’s AutoML engine.
The registry contains standardized PET readings from >15,000 patients across 50+ institutions since 2018; the project will compare AI predictions with established prognostic nomograms.
Telix (ASX: TLX, NASDAQ: TLX) will participate in two investor conferences in late February and early March 2026. Key executives will present and both sessions will be webcast live and available via the company's investor relations website.
Dr. Christian Behrenbruch will join a fireside chat at Oppenheimer on Feb 26, 2026 (4:40 p.m. EST). Kevin Richardson and Dr. Behrenbruch will present at TD Cowen on Mar 2, 2026 (1:50 p.m. EST). Registration and webcast links are on the investor relations events page.
Telix (TLX) reported FY2025 revenue of US$803.8M, up 56% year‑over‑year, adjusted EBITDA of US$39.5M, and a small loss before tax of US$5.3M. Year‑end cash was US$141.9M after US$246.4M of strategic M&A investments.
Precision Medicine revenue rose 22% with stable gross margin (64%). R&D investment totaled about US$157.1M for product development; FY2026 guidance is US$950–970M revenue and US$200–240M pipeline R&D spend.