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Highlights

  • Telix Pharmaceuticals shares rise 1.5% in Friday morning trade, now up 112.6% year-over-year.
  • FDA approves Telix’s new imaging agent, Gozellix, for prostate cancer detection.
  • Gozellix extends shelf life to six hours, enabling broader distribution and improved accessibility across the US.

Telix Pharmaceuticals Ltd (ASX:TLX) continues its upward trajectory, with shares climbing 1.5% in Friday morning trade to AU$28.22. This marks an impressive 112.6% gain over the past year, significantly boosting investor returns.

The S&P/ASX 200 healthcare stock has further improved its position with the United States Food and Drug Administration (FDA) granting approval for its latest imaging agent, Gozellix, designed to enhance prostate cancer diagnosis.

FDA Greenlight for Gozellix

Telix announced that the FDA has approved its New Drug Application (NDA) for Gozellix, a next-generation PSMA-PET imaging agent for prostate cancer. Once radiolabelled with gallium-68 (68-Ga), Gozellix enables high-precision PET scanning for:

  • Patients with suspected prostate cancer metastasis who are candidates for initial therapy.
  • Individuals with suspected recurrence based on elevated prostate-specific antigen (PSA) levels.

One of Gozellix’s key advantages is its longer shelf life of up to six hours, significantly extending its distribution range beyond current gallium-based imaging products. This means it can reach more PET cameras in underserved areas, ensuring broader patient access across the US.

Telix highlighted that Gozellix’s scalable production could enhance operational efficiency and scheduling flexibility for scanning clinics, helping them accommodate more patients while maintaining imaging accuracy.

Telix’s stock performance has rewarded investors handsomely. A AU$5,000 investment in TLX shares on 21 March 2020 would now be worth a staggering AU$162,185.