Telix Posts $804M Fiscal 2025 Revenue, Phase 3 TLX591-Tx Trial Meets Safety Endpoints
Telix reported fiscal 2025 revenue of $804 million, hitting its $800–$820 million guidance, while fourth-quarter sales climbed 46% year-over-year to $208 million. The ProstACT Global Phase 3 Part 1 trial for investigational TLX591-Tx met safety and tolerability endpoints in 36 mCRPC patients and will be presented to the FDA to support a 490-patient Part 2 study.
1. Phase 3 Part 1 Primary Endpoint Achievement
The ProstACT Global Phase 3 Part 1 study evaluated TLX591-Tx, a lutetium-177 radio antibody-drug conjugate, in 36 metastatic castration-resistant prostate cancer patients. The trial confirmed an acceptable safety and tolerability profile, as well as favorable biodistribution and dosimetry after two doses administered 14 days apart in combination with standard therapies.
2. FDA Submission and Part 2 Study Plans
Telix plans to present Part 1 data to the FDA to obtain an Investigational New Drug amendment, paving the way for Part 2. The expanded study aims to enroll approximately 490 patients, assessing TLX591-Tx’s safety profile and potential as a first-line treatment alongside contemporary standard-of-care regimens.
3. Fiscal 2025 Revenue Performance
Australia-based Telix delivered fiscal 2025 revenue of about $804 million, matching its upgraded guidance range of $800 million to $820 million. Fourth-quarter revenue rose 46% year-over-year to roughly $208 million, reflecting strong commercial uptake and positioning the company for continued growth.