Telix Pharmaceuticals Ltd (ASX: TLX) shares are having a strong session on Wednesday.
In afternoon trade, the ASX 200 radiopharmaceuticals company's shares are up 7% to $25.71.
This compares favourably to the performance of the benchmark ASX 200 index, which is down 0.3% at the time of writing.
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Why are Telix shares jumping?
Investors have been bidding the company's shares higher today after it was given a big boost in the key United States market.
According to the release, Telix's next-generation PSMA PET imaging agent, Gozellix, has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).
The release notes that effective from 1 October 2025, CMS and commercial health insurers will recognise the HCPCS Level II code A9616 assigned for reimbursement of Gozellix.
Management believes the assignment of the code is a significant milestone supporting provider billing and reimbursement for Gozellix, and a further step toward receiving Transitional Pass-Through (TPT) payment status.
What is Gozellix?
Gozellix is a kit for the preparation of gallium-68 (68Ga) gozetotide injection.
After radiolabelling with 68Ga, Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy.
It is also indicated for those with suspected biochemical recurrence (BCR) based on elevated serum prostatespecific antigen (PSA) level.
Management notes that with its extended shelf-life and flexible production options, Gozellix overcomes many of the logistical barriers that have historically limited access to PSMA-PET imaging.
It believes receiving a HCPCS code will support clinical adoption of Gozellix and expanded access to PSMA PET imaging.
'A significant step forward'
Commenting on the news, Telix's chief executive officer of Precision Medicine, Kevin Richardson, Telix, said:
Being granted a HCPCS code marks a significant step forward in Telix's mission to improve access to precision medicine imaging for prostate cancer patients across the United States, regardless of their location. It is also an important enabler for commercial scale-up and reimbursement of Gozellix in the U.S. as we bring our next-generation PSMA PET imaging agent to market.
This looks set to be a major milestone for Telix and could be a significant boost to its revenue growth in the coming years. For this reason, it is not a surprise to see its shares jump on the news.
Following today's gain, Telix shares are now up 40% since this time last year.
