Q1 2026: Strong Revenue Growth and Therapeutics Pipeline Advancement
MELBOURNE, Australia and INDIANAPOLIS, April 07, 2026 -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) provides a market update on its commercial and operational performance for the quarter ended March 31, 2026 (Q1 2026).
Q1 2026 Highlights
- Q1 2026 unaudited Group revenue of US$230 million, up 11% quarter-over-quarter.
- FY 2026 revenue guidance of US$950 million to US$970 million is reaffirmed.
- Precision Medicine Q1 2026 unaudited revenue of US$186 million, up 16% quarter-over-quarter. Strong revenue growth in both Illuccix® and Gozellix® segments.
- ProstACT® Global Phase 3 study of TLX591-Tx prostate cancer therapy candidate: Part 1 lead-in met safety and dosimetry objectives, with no new safety signals observed
1.
- TLX101-Px (brain cancer imaging candidate): New Drug Application (NDA) resubmitted to the United States (U.S.) Food and Drug Administration (FDA)
2for Pixclara®3. Marketing Authorization Application (MAA) filed in Europe4for Pixlumi®3.
- TLX591-Px
5: NDA accepted in China by the National Medical Products Administration (NMPA)6.
Q1 2026 Revenue (Unaudited)
| Revenue (US$M) | Q1 2026 | Q1 2025 | Variation | Q4 2025 | Variation |
| Group revenue | 230 | 186 | 24% | 208 | 11% |
| Precision Medicine revenue
7
|
186 | 151 | 23% | 161 | 16% |
| TMS third-party revenue
8
|
44 | 34 | 29% | 44 | —% |
Executive Commentary
Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, “Growth accelerated across our Precision Medicine business in the first quarter, with U.S. dose volumes increasing 5% quarter-over-quarter. This performance reflects the growing uptake of Gozellix alongside Illuccix, contributing to market share gains underpinned by disciplined sales execution and pricing, and high-quality service delivery despite extreme North American weather conditions, an advantage of the pharmacy distribution model. With our two‑product PSMA
Therapeutics Business Unit
Telix continues to progress its industry-leading Therapeutics pipeline, which spans multiple product candidates and disease areas. Q1 2026 highlights include:
- TLX591-Tx (lutetium (
177Lu) rosopatamab tetraxetan): Part 1 of ProstACT Global, the Phase 3 trial of its lead prostate cancer therapy candidate, achieved its study objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed1. No adverse drug-drug interactions were observed in TLX591-Tx combinations, demonstrating the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC10, including ARPIs11(enzalutamide or abiraterone) and docetaxel. Telix has commenced engagement with the FDA to present data from Part 1 and ascertain eligibility for U.S. patients to participate in Part 2 (randomized treatment expansion). Part 2 is open for enrollment in Australia, New Zealand and Canada, with site activation underway in preparation to open enrollment in China, Singapore, South Korea, Türkiye, the United Kingdom and Japan, where regulatory approvals have already been granted.
- TLX250-Tx (lutetium (
177Lu) girentuximab tetraxetan): Telix has opened its first clinical site and is recruiting patients for Part 1 of LUTEON12, a pivotal trial of TLX250-Tx as a monotherapy in advanced ccRCC13. Trial recruitment will initially focus ex-U.S.
- TLX101-Tx (
131I-iodofalan): Telix has enrolled the first patient in IPAX-BrIGHT, an international, multi-center pivotal trial of TLX101-Tx in patients with recurrent glioblastoma14. The trial is now open for enrollment in Australia, Austria and the Netherlands and has received regulatory approval to commence in Belgium.
- TLX090-Tx (
153Sm-DOTMP): Telix continues to dose patients in SOLACE15, a Phase 1 study of a drug candidate for treating pain in patients with osteoblastic bone metastases from prostate and breast cancers. The study was expanded this quarter to include additional U.S. sites to accelerate recruitment.
- TLX597-Tx (
177Lu-DOTA-HYNIC-panPSMA): TLX597-Tx is a "next generation" PSMA-targeting prostate cancer therapy candidate being developed to facilitate patient access in select geographies, where routine clinical availability to approved therapies is limited or not available. Early clinical data suggests a favorable asset biodistribution with limited uptake in healthy organs of concern (e.g., salivary glands, kidneys) relative to available177Lu-PSMA therapies. Interim data from OPTIMAL-PSMA16, an investigator-led, randomized, dose intensification study of TLX597-Tx in mCRPC, will be presented at the International Prostate Cancer Symposium in April 2026.
Precision Medicine Business Unit
PSMA imaging portfolio:
- Telix continues to expand its commercial footprint with Illuccix now launched in 21 countries globally, which includes 16 countries in Europe. This growing international presence enhances access to PSMA-PET/CT imaging
17while establishing a scalable commercial and operational platform to support future product launches, including follow-on therapeutic products.
- Telix's broad proposed label for TLX591-Px (Illuccix) is under review by the NMPA Centre for Drug Evaluation as part of the NDA submission
18.
TLX101-Px, (Floretyrosine F 18 or
- Telix has resubmitted its NDA in the U.S. with the additional clinical data and analysis as agreed with the FDA.
- Telix has submitted a MAA in Europe covering commercially significant markets, seeking to expand patient access to advanced brain imaging.
Zircaix®
- Based on two successful Type A meetings with the FDA, Telix believes it has aligned on key outstanding issues for the Biologics License Application (BLA) resubmission, including demonstration of drug product comparability between clinical trial material and scale-up commercial production. The Company is now completing the agreed deliverables and documentation required, targeting a H1 2026 submission.
Corporate Updates
Telix has announced the appointment of David Gill as Non-Executive Director (NED), effective May 11, 2026, as part of its Board renewal process
FY 2026 guidance
- Telix reaffirms FY 2026 revenue guidance of US$950 million to US$970 million
20.
- Guidance reflects revenue from product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS.
- Telix reaffirms research and development (R&D) expenditure guidance of US$200 million to US$240 million, subject to achieving ongoing global commercial milestones.
About Telix Pharmaceuticals Limited
Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Illuccix (kit for the preparation of gallium-68 (
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
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