Telix Pharmaceuticals Ltd (ASX: TLX) shares are racing higher on Tuesday morning.
At the time of writing, the radiopharmaceuticals company's shares are up 22% to $18.32.
This compares favourably to a 0.3% gain by the ASX 200 index in early trade.
Why are Telix shares rocketing today?
Investors have been bidding the company's shares higher today after it released a very positive announcement before the market open.
According to the release, the United States Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix (kit for the preparation of gallium-68 gozetotide injection). It is Telix's next generation PSMA-PET imaging agent for prostate cancer.
The company notes that this designation enables separate reimbursement for Gozellix under the Hospital Outpatient Prospective Payment System (HOPPS), effective 1 October 2025. Management feels that this marks a significant milestone in Telix's U.S. commercial strategy.
Gozellix has already been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616 to be recognised by CMS and commercial health insurers. In addition, patients are not subject to the 20% patient coinsurance under TPT.
What is Gozellix?
After radiolabelling with a gallium-68 gozetotide injection, 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, as well as those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level.
Gozellix is a novel imaging agent offering a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products. The company notes that this helps to overcome many of the logistical barriers that have historically limited access to PSMA-PET imaging.
Commenting on the news, Telix CEO of Precision Medicine, Kevin Richardson, said:
Granting TPT status for Gozellix is a strong endorsement of the clinical value of our next-generation imaging agent. Gozellix is already available nationally, and this reimbursement milestone will reduce the out-of-pocket burden for patients, enhance patient access to advanced prostate cancer imaging and simplify payment for providers. As the only provider with two FDA-approved and reimbursed products in this class, we are pleased to make PSMA-PET/CT imaging accessible to more patients and providers across the U.S.
Despite today's impressive gain, Telix shares remain down 42% from their 52-week high.
