Telix Pharma wins FDA approval for brain cancer treatment, shares surge

Telix Pharmaceuticals Ltd (ASX:TLX) announced on Monday that the U.S. Food and Drug Administration had granted approval for its brain cancer imaging drug Pixclara, leading to a significant surge in its Australian shares. The company's stock rose as high as 12% to A$17.65 in the Sydney trade before settling at a 2.6% gain by 21:55 ET (01:55 GMT).

The FDA's approval of Telix's new drug application for the treatment marks a major breakthrough, making Pixclara widely accessible in the United States. Pixclara is a radioactive diagnostic drug specifically designed for glioma, a prevalent form of brain cancer. This is the first of its kind to receive FDA approval in the U.S., positioning Telix to tap into a new revenue stream.

The FDA approval is anticipated to substantially boost Telix's market presence in the U.S., generating a surge in its shares. To date in 2026, Telix shares have already increased by nearly 43%.