Telix Pharmaceuticals Secures U.S. Reimbursement Code for Gozellix® in Major Commercial Milestone

Key Highlights:

• Gozellix granted permanent HCPCS Level II code by U.S. CMS
• Reimbursement effective from October 1, paving way for commercial scale-up
• Enhances access to advanced PSMA PET imaging for prostate cancer
• Stock rises 6.91% to A$25.70 as market applauds U.S. reimbursement progress
  
   

Telix’s Gozellix Receives U.S. Reimbursement Code, Boosting Commercial Prospects and Market Momentum

In a pivotal update for Australian biotech Telix Pharmaceuticals Ltd (ASX: TLX, NASDAQ: TLX), the company announced on Wednesday it has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code for its next-generation PSMA PET imaging agent, Gozellix®. The U.S. Centers for Medicare & Medicaid Services (CMS) decision is expected to significantly accelerate clinical uptake and commercial momentum in the world’s largest healthcare market.

Effective from 1 October 2025, the HCPCS Level II code A9616 will enable billing and reimbursement for Gozellix, supporting broader patient access to precision imaging for prostate cancer. The announcement saw Telix shares climb 6.91% to A$25.70 in afternoon trade, adding fresh energy to the company’s already strong year-to-date performance.

“This is 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,” said Kevin Richardson, CEO of Telix’s Precision Medicine division. “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” .

What Gozellix Does and Why It Matters

Gozellix, a gallium-68 gozetotide injection, is Telix’s next-generation prostate-specific membrane antigen (PSMA) PET imaging agent. It’s indicated for identifying PSMA-positive lesions in men with prostate cancer who are either newly diagnosed or experiencing biochemical recurrence based on elevated PSA levels.

Crucially, Gozellix offers improvements over earlier-generation products due to its extended shelf-life and flexible production capabilities, removing logistical barriers that previously limited access to this advanced diagnostic modality.

With CMS approval now in place, Telix is also eyeing Transitional Pass-Through (TPT) payment status, which would unlock further Medicare reimbursement benefits and strengthen its competitive edge against incumbent radiopharmaceutical providers.

Market Opportunity and Competitive Landscape

The U.S. PSMA PET imaging market is forecasted to grow rapidly, driven by higher prostate cancer incidence and increasing demand for personalised oncology solutions. Telix’s first-generation imaging agent, Illuccix®, has already seen strong adoption across multiple markets. The evolution to Gozellix is viewed as a natural and timely progression.

The permanent coding assignment also positions Telix to expand its commercial partnerships and streamline hospital billing, two critical hurdles in radiopharmaceutical uptake.

“This reimbursement milestone is not only a regulatory achievement but a commercial accelerator,” said Annie Kasparian, Director of Investor Relations at Telix U.S., in a statement. “It validates the clinical utility of Gozellix and strengthens the business case for hospitals and imaging centres to adopt it.”

Global Footprint and Growth Trajectory

Telix has emerged as a leader in radiopharmaceutical innovation, combining diagnostics and therapeutics—a concept known as theranostics. Headquartered in Melbourne, the company maintains a global presence across North America, Europe, Asia, and Latin America, with several products in advanced clinical stages targeting kidney, brain, and rare cancers.

The Gozellix milestone underscores Telix’s growing U.S. strategy, where pricing and reimbursement pathways play a pivotal role in commercial success. Moreover, it demonstrates Telix’s ability to navigate the complex U.S. healthcare system—a feat that sets it apart from many of its ASX-listed biotech peers.

Investor Sentiment and Stock Performance

Telix’s stock has delivered a 42.78% return over the past year, outpacing both the ASX Health Care Index and broader market benchmarks. With a market cap now approaching A$8.7 billion, TLX is considered one of the ASX’s most successful biotech stories of the past five years.

Analysts view the reimbursement code as a key de-risking event that could unlock further upside. “We expect Telix to see strong clinical demand post-October as reimbursement clarity accelerates adoption. This is a validation of its strategy and opens the door to near-term revenue growth,” noted a healthcare analyst at Morgans, adding that more institutions could now consider adding TLX to their growth portfolios.

What Comes Next?

The HCPCS code for Gozellix not only supports patient access but also enhances Telix’s competitive standing in the fast-growing U.S. molecular imaging space. As the company moves towards commercial deployment this October, investors and clinicians alike will be watching for updates on market penetration, Medicare billing volumes, and the long-term revenue potential of the platform.

With the prostate cancer diagnostics field heating up, and radiopharmaceuticals gaining traction as mainstream oncology tools, Telix appears well-positioned to lead the next wave of innovation.

Telix Pharmaceuticals Ltd (ASX: TLX)

• Price: A$25.70
• Change: +1.66 (+6.91%)
• Market Cap: A$8.70B
• 52-Week Range: A$17.03 – A$31.97
• Volume (July 9, 2025): 984,701 shares