# Telix Pharmaceuticals diagnostic drug developments

> Live situation record from CLSTR: https://clstr.news/situations/telix-pharmaceuticals-diagnostic-drug-developments
> Updated: 2026-10-07T06:13:02.000Z. Sources: 10. Developments: 3.

Telix Pharmaceuticals has achieved regulatory milestones for its diagnostic imaging products in the United States. The FDA approved Pixclara (floretyrosine F 18), a radioactive drug for imaging gliomas in both adult and pediatric patients. This approval provides a tool to help clinicians differentiate between recurrent or progressive glioma and changes from previous treatments.

Following this, the FDA granted Fast Track designation to Telix’s BiPASS program. This program combines gallium-68 PSMA-PET imaging with MRI to facilitate earlier and less invasive prostate cancer diagnosis, aiming to reduce the frequency of unnecessary biopsies.

Following the Fast Track designation, UBS upgraded its share price target for Telix Pharmaceuticals. Analysts noted that a successful BiPASS study could “nearly double the total addressable market for Telix’s PSMA compounds.” The broker suggested that the market may be underestimating the commercial potential and the probability of success for this diagnostic tool, which addresses a significant unmet medical need in prostate cancer care.

## Timeline

### 2026-10-07: Telix Pharmaceuticals receives FDA fast-track designation for cancer detection program

UBS upgraded Telix Pharmaceuticals' share target after the FDA granted fast-track designation to its BiPASS program for prostate cancer detection.

2 sources. https://clstr.news/cluster/telix-pharmaceuticals-receives-fda-fast-track-designation-for-cancer-detection-program

### 2026-09-28: Lexicon and Telix Pharmaceuticals see developments in drug ratings and FDA designations

Lexicon Pharmaceuticals stock rose following a bullish analyst rating for its drug sotagliflozin, while Telix Pharmaceuticals received FDA Fast Track designation for its prostate cancer imaging program.

5 sources. https://clstr.news/cluster/lexicon-pharmaceuticals-and-tilray-brands-see-divergent-stock-movements

### 2026-09-14: Telix Pharmaceuticals' Pixclara receives FDA approval for brain cancer imaging

The FDA has approved Telix Pharmaceuticals’ Pixclara, the first FET-PET imaging drug for glioma, to help diagnose and monitor brain cancer in adults and pediatric patients.

5 sources. https://clstr.news/cluster/pharmaceutical-companies-tonix-and-telix-report-clinical-and-regulatory-developments

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Cite as: Telix Pharmaceuticals diagnostic drug developments. CLSTR, https://clstr.news/situations/telix-pharmaceuticals-diagnostic-drug-developments