TLX Stock Clocks 5% Gain This Week Ahead Of FDA Decision On Brain Cancer Imaging Agent

The FDA’s target date for deciding on Pixclara is September 11.

• Telix already has two FDA-approved prostate cancer scan drugs: Illuccix, cleared in December 2021, and Gozellix, approved in March 2025.
• Telix has not baked any Pixclara sales into its 2026 forecast, so approval would be extra to current guidance.
• The FDA refused to approve Pixclara in 2025 and sought more evidence.

NASDAQ-listed shares of Telix Pharmaceuticals (TLX) climbed this week as investors focused on a U.S. Food and Drug Administration (FDA) decision due next Friday on the company’s brain-cancer imaging agent.

TLX stock was trading around $11.90 on Friday, up roughly 5% from last Friday’s close of $11.29. The biggest lift this week came on Wednesday, when the shares jumped 5.5% after Telix said it had finished enrolling in a late-stage prostate imaging study.

Impending Decision

The FDA’s target date for deciding on Pixclara is September 11. Pixclara is a PET scan dye meant to help doctors tell whether a glioma — an aggressive brain tumor — is coming back or whether the scan is only showing damage from earlier treatment. That distinction is difficult to make with standard imaging and can affect how patients are treated.

The product already has Fast Track and Orphan Drug status. Telix has not baked any Pixclara sales into its 2026 forecast, so approval would be in addition to its current guidance of $950 million to $970 million in revenue.

A Second Try At The FDA

The company first filed for approval of Pixclara in 2024. The FDA accepted the filing and granted it priority review, then rejected it in April 2025 and requested additional supporting evidence. Telix resubmitted in March. The agency accepted the new package on April 10 and set next week’s deadline.

Telix already has two FDA-approved prostate cancer scan drugs: Illuccix, cleared in December 2021, and Gozellix, approved in March 2025. Those products now drive most sales. A kidney-cancer scan, Zircaix, was also rejected last year and is being prepared for another filing later this year.

Pixclara would give Telix a third commercial imaging product and a foothold in brain cancer. Approval would also add a product not yet included in the sales outlook, while the core prostate business continues to grow.

How Did TLX Retail Traders React?

On Stocktwits, retail sentiment around TLX stock remained ‘bullish’ over the past 24 hours, while message volume rose from ‘low’ to ‘normal’ levels.

TLX stock has risen 59% year-to-date. 

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