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Highlights

  • Bell Potter assigns a Buy rating to Telix Pharmaceuticals Limited.
  • Company advances U.S. commercial strategy with CMS reimbursement status for Gozellix®.
  • NDA resubmission for Pixclara® planned for Q4 2025 following FDA engagement.

Telix Pharmaceuticals Limited (ASX:TLX) (NASDAQ:TLX) has received a Buy rating from Bell Potter Securities, one of the brokers covering the company. Recently, Telix continues to make regulatory and commercial progress across its oncology imaging and therapy pipeline.

Commercial Progress in the United States

On 23 September 2025, Telix announced that the United States Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through (TPT) payment status for Gozellix®, its next-generation PSMA-PET imaging agent for prostate cancer.

This designation, effective from 1 October 2025, ensures that Gozellix® will be separately reimbursed under the Hospital Outpatient Prospective Payment System (HOPPS). The product has also been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616, further supporting its recognition by CMS and commercial health insurers.

In addition, participants will not be subject to the 20% coinsurance under the TPT program, improving access and affordability. This marks a significant development in Telix’s U.S. commercial rollout.

Progress with Pixclara® NDA

Earlier this month, on 9 September 2025, Telix confirmed an agreement with the U.S. Food and Drug Administration (FDA) regarding the resubmission of its New Drug Application (NDA) for Pixclara® (TLX101-CDx, Floretyrosine F18 or 18F-FET).

Pixclara® is an investigational imaging agent for glioma, a rare and life-threatening brain cancer. Following a successful Type A meeting with the FDA, Telix received guidance to provide an additional confirmatory efficacy study analysis based on existing data.

The company intends to resubmit the NDA package in Q4 2025, aiming to address matters raised in the FDA’s earlier Complete Response Letter.

As of the latest trading session, Telix shares were priced at AUD 14.85, down 3.45% on the day.