On April 6, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") reported a market update on its commercial and operational performance for the quarter ended March 31, 2026 (Q1 2026).
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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$186 million, up 16% quarter-over-quarter. Strong revenue growth in both Illuccix and Gozellix segments.
ProstACT Global Phase 3 study of TLX591-Tx prostate cancer therapy candidate: Part 1 lead-in met safety and dosimetry objectives, with no new safety signals observed1.
TLX101-Px (brain cancer imaging candidate): New Drug Application (NDA) resubmitted to the United States (U.S.) Food and Drug Administration (FDA)2 for Pixclara3. Marketing Authorization Application (MAA) filed in Europe4 for Pixlumi3.
TLX591-Px5: NDA accepted in China by the National Medical Products Administration (NMPA)6.
Q1 2026 Revenue (Unaudited)
Revenue (US$M) Q1 2026 Q1 2025 Variation Q4 2025 Variation
Group revenue 230 186 24% 208 11%
Precision Medicine revenue7 186 151 23% 161 16%
TMS third-party revenue8 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 PSMA9 imaging strategy, differentiated clinical positioning and expanding commercial presence globally, we are seeing a solid foundation for continued growth through 2026. Importantly, we are delivering on our strategic priorities to advance our high-value clinical programs, demonstrated by the momentum in our therapeutics pipeline this quarter."
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 available 177Lu-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 imaging17 while 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 submission18.
TLX101-Px, (Floretyrosine F 18 or 18F-FET):
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.
Zircaix3 (TLX250-Px, 89Zr-DFO-girentuximab):
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 process19. Mr. Gill is expected to be appointed as Chair in due course, succeeding Dr. Mark Nelson who will remain on the Board as NED. The Board believes Mr. Gill’s appointment will enhance the Board’s capability, with extensive experience in U.S. public company governance, financial oversight and senior leadership across commercial and clinical-stage biopharmaceutical companies.
FY 2026 guidance
Telix reaffirms FY 2026 revenue guidance of US$950 million to US$970 million20.
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.
(Press release, Telix Pharmaceuticals, APR 6, 2026, View Source [SID1234664194])