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Telix Pharmaceuticals Rallies as U.S. Grants Key Approval for Prostate Cancer Imaging Product

Sep 23, 2025

Highlights:

  • Telix Pharmaceuticals Limited (ASX: TLX) shares rose 6.43% at the time of writing after U.S. regulators granted payment approval for Gozellix.
  • The Centers for Medicare & Medicaid Services (CMS) granted transitional pass-through payment status, easing hospital adoption of the imaging product.
  • The approval is expected to boost patient access, accelerate U.S. market growth, and strengthen investor confidence in Telix’s pipeline.

Market Surge

Telix Pharmaceuticals Limited (ASX: TLX) saw its shares surge after announcing a major regulatory win in the United States. Telix Pharmaceuticals Rallies as U.S. Grants Key Approval for Prostate Cancer Imaging Product.

What the Approval Means

The pass-through status from CMS is a significant milestone for Telix. This designation enables hospitals and imaging centres to receive separate payments for Gozellix when used in outpatient procedures. By reducing financial barriers, the ruling is expected to expand patient access and accelerate adoption across U.S. healthcare providers.

Gozellix is designed to improve prostate cancer detection through advanced molecular imaging, offering more precise diagnostic insights compared to traditional methods. With prostate cancer remaining one of the most prevalent cancers in men, Telix’s product could play a vital role in enhancing early detection and treatment planning.

Investor Confidence Boosted

The announcement not only underscores Telix’s growing global footprint but also strengthens investor confidence in its pipeline. The U.S. market is considered critical for Telix’s long-term growth, and today’s regulatory development provides a pathway for revenue acceleration. Analysts believe the CMS approval could pave the way for broader commercial success and potentially set the stage for similar approvals in other jurisdictions. For shareholders, the rally highlights renewed optimism about Telix’s ability to convert its research investments into meaningful financial returns.

At the time of writing, Telix Pharmaceuticals Limited (ASX: TLX) was trading at $15.965, up 6.43% or 0.965 points, marking one of the strongest performances on the Australian Securities Exchange (ASX) today.

What the Approval Means

The pass-through status from CMS is a significant milestone for Telix. This designation enables hospitals and imaging centres to receive separate payments for Gozellix when used in outpatient procedures. By reducing financial barriers, the ruling is expected to expand patient access and accelerate adoption across U.S. healthcare providers.

Gozellix is designed to improve prostate cancer detection through advanced molecular imaging, offering more precise diagnostic insights compared to traditional methods. With prostate cancer remaining one of the most prevalent cancers in men, Telix’s product could play a vital role in enhancing early detection and treatment planning.

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