Key Highlights

  • The FDA granted Fast Track Designation to Telix's BiPASS program, which evaluates 68Ga-PSMA-PET imaging with MRI before prostate biopsy.
  • Telix has completed enrolment in the Phase 3 BiPASS study and is planning a new drug application submission.
  • Pre-biopsy use of Illuccix and Gozellix is investigational and not approved by the FDA or any other regulator.

Telix Pharmaceuticals Limited (ASX:TLX) (NASDAQ: TLX) announced on 30 September 2026 that the US Food and Drug Administration has granted Fast Track designation to its BiPASS program. BiPASS (Biopsy of the Prostate Avoidance Stratification Study) evaluates gallium-68 PSMA-PET imaging in combination with MRI for detecting prostate cancer before biopsy.

What Fast Track provides

Fast Track is a process designed to facilitate development and expedite review of drugs for serious conditions that Fill an unmet medical need. The announcement says it facilitates more frequent engagement with the FDA and may enable expedited review of the planned new drug application (NDA), potentially accelerating patient access if the product is approved. The designation does not itself approve the product or guarantee an expedited review.

Clinical and unmet need context

Telix cites more than three million prostate biopsies performed globally each year, with up to 75% producing a negative result, and notes biopsy can be stressful and painful. BiPASS builds on the PRIMARY and PRIMARY2 studies, which it says showed that combining 68Ga-PSMA-PET with MRI can significantly improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50%. The company states BiPASS is not intended to replace biopsy where it benefits the patient, but to help clinicians decide who needs a biopsy and where it should be targeted.

Regulatory status

Telix recently completed enrolment in the Phase 3 BiPASS study of its proprietary 68Ga-PSMA-PET agents, Illuccix and Gozellix. It has positively engaged the FDA on an NDA pathway, which supports registration as a new product that, if approved, would broaden access to the imaging for a substantially larger patient population, and it is planning its submission. The study is registered as NCT07052214.

Current approvals and company profile

Illuccix and Gozellix are approved for PET imaging of PSMA-positive lesions in prostate cancer patients with suspected metastasis who are candidates for initial definitive therapy, and in patients with suspected recurrence based on elevated PSA. Illuccix is also approved for selecting patients for PSMA-directed therapy. Telix describes itself as a commercial-stage radiopharmaceutical company, with Illuccix available in 22 countries, Gozellix approved by the FDA, and Pixclara approved by the FDA for glioma imaging. Its late-stage therapeutic pipeline includes TLX591-Tx, TLX101-Tx and TLX250-Tx, none of which has received Marketing authorisation.

Supporting studies

BiPASS builds on the PRIMARY study, published in European Urology in 2021, and PRIMARY2, published in The Lancet Oncology in 2026. The company says these demonstrated that adding 68Ga-PSMA-PET to MRI can significantly improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50%. The BiPASS study is registered as NCT07052214, and PRIMARY2 as NCT05154162.

What remains to be done

Phase 3 enrolment is complete, but the release does not report BiPASS results or give a date for the NDA submission. The FDA may or may not accept the filing, and the pre-biopsy indication would require approval before use outside trials. The company says the designation supports continued close engagement with the FDA as it advances toward the submission.