Reimbursement Milestone Lifts Telix Pharmaceuticals Share
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United States (U.S.) Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through (TPT) payment status for Gozellix, Telix’s next generation PSMA-PET1 imaging agent for prostate cancer.
TPT status for Gozellix is considered a strong endorsement of the clinical value of the company’s next-generation imaging agent.
Telix Pharmaceuticals Limited (ASX: TLX)
had a solid run in September 2025 with two big updates. On 23 September the U.S. Centers for Medicare and Medicaid Services gave Transitional Pass Through status to Gozellix which means from 1 October it gets separate reimbursement and that helps more patients get access to prostate cancer imaging. Earlier on 9 September Telix also reached agreement with the FDA for the resubmission of TLX101-CDx Pixclara, a glioma imaging product. The company will send the resubmission in Q4 2025 and a faster review is expected. Both these events fit into Telix plan to grow its footprint in the U.S.
For the half-year FY25 results Telix posted revenue of about US$390.4 million which was 63% higher compared to last year. The strong U.S Illuccix sales and the RLS buyout helped a lot in this jump. Precision Medicine sales went up almost 30% and margins stayed steady at 64%. EBITDA for the group was up 24% and operating cash flow was positive at US$17.7 million. Even after spending US$241.8 million on acquisitions the company still had a healthy US$207.2 million in cash. Net profit before tax showed a small loss of US$4.8 million because of more R&D and commercial spending. The company has kept its full year guidance of US$770–800 million revenue and also said R&D expenses will go up 20–25% in FY25.
The pipeline is also moving well with trials across prostate, kidney and brain cancers. Important near term goals include the start of Part 2 of the ProstACT Global Phase 3 study for TLX591, pivotal trials for TLX250 in kidney cancer and the IPAX-BRIGHT study for glioblastoma. The company is also working on early stage alpha therapies TLX592 and TLX252 aimed at prostate and CAIX-expressing tumors. On the production side capacity is expanding fast with new GMP facilities in Japan and Belgium plus more sites from the RLS U.S. network. With two PSMA imaging products already approved, upcoming filings for Zircaix and Pixclara and more therapies in the pipeline, Telix is in a strong place in radiopharma space. Its steady financials along with wider global reach and pipeline progress all support the goal of long term value creation.
(Source: Company Announcements)
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