Telix Pharmaceuticals receives FDA approval for prostate cancer screening agent

Key Takeaways

• Telix Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its agent for prostate cancer screening.
• Gozellix may be indicated for PET scans in men with prostate cancer lesions that are positive, or those who could have a recurrence.
• The Australian biopharmaceutical company began U.S. trade four months ago. Since then, shares have increased by more than 20%.

The shares of Australia-based Telix Pharmaceuticals rose 6% after the U.S. Food and Drug Administration’s (FDA) approval for the biopharma firm to use its agent in tests for screening 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 began trading in the U.S. only in November. Since then, they have risen by more than 20%.