:max_bytes(150000):strip_icc()/GettyImages-1237662188-7e139af22fde43fba72b16f4f541834c.jpg?w=780&resize=780,470&ssl=1 "Telix Pharmaceuticals Gets FDA Approval for Prostate Cancer Screening Agent")
Key Takeaways
- Telix Pharmaceuticals reported that the U.S. Food and Drug Administration approved its agent indicated for prostate cancer screenings.
- Gozellix is indicated for PET scan testing for men with positive prostate cancer lesions, and those who may have a recurrence of the disease.
- The Australian biopharmaceutical firm began U.S. trading four months ago, and shares have added more than 20% since.
Shares of Australia-based Telix Pharmaceuticals (TLX) rose 6% Friday as the U.S. Food and Drug Administration (FDA) approved the biopharma firm’s agent for use in tests to screen for prostate cancer.
Telix explained that the drug, Gozellix, is indicated for Positron Emission Tomography (PET) scanning of Prostate-Specific Membrane Antigen (PSMA) “positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy.” It’s also designed for those with suspected recurrence based on an elevated serum prostate-specific antigen (PSA) level.
The company explained that Gozellix has a longer shelf life than gallium-based imaging products currently on the market, “bringing the accuracy and clinical utility of gallium-based imaging to more patients across the U.S.”
Kevin Richardson, CEO of Telix Precision Medicine, called the FDA decision “a major win for prostate cancer patients.”
Telix Pharmaceutical shares only began U.S. trading in November, and they’re up more than 20% since.
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