Telix Pharmaceuticals (ASX:TLX) Receives FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Imaging Program

Sonal Goyal

30 September 2026 12:40 PM AEST

Telix Pharmaceuticals (ASX:TLX) Receives FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Imaging Program

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Key Highlights

• The FDA granted Telix Pharmaceuticals FDA Fast Track Designation for its BiPASS prostate cancer pre-biopsy imaging program.

• BiPASS is a Phase 3 study evaluating 68Ga-PSMA-PET imaging alongside MRI for prostate cancer detection prior to biopsy.

• Telix has completed enrolment in the Phase 3 BiPASS study and is engaging with the FDA on an NDA pathway.

• Fast Track designation may enable more frequent FDA engagement and expedited review of the planned New Drug Application.

Telix Pharmaceuticals Limited (ASX:TLX, NASDAQ:TLX), a commercial-stage radiopharmaceutical company headquartered in Melbourne, announced on 30 September 2026 that the United States Food and Drug Administration has granted Fast Track designation for the company's BiPASS program. BiPASS evaluates the use of gallium-68 PSMA-PET imaging in combination with MRI for the detection of prostate cancer prior to biopsy.

About Telix Pharmaceuticals

Telix Pharmaceuticals is a commercial-stage global radiopharmaceutical company advancing targeted theranostics — precision diagnostics paired with targeted therapies — across cancer indications. The company's commercial Franchise includes Illuccix and Gozellix, both 68Ga-PSMA-PET imaging agents approved for prostate cancer imaging and commercially available in multiple countries including the United States. Telix also holds Pixclara, approved by the FDA for glioma imaging, and maintains a late-stage therapeutic pipeline across prostate, kidney, and glioblastoma cancers.

BiPASS Program: Design and Background

BiPASS — Biopsy of the Prostate Avoidance Stratification Study — is a Phase 3 clinical trial evaluating Illuccix and Gozellix in combination with MRI for the detection of prostate cancer in the pre-biopsy setting, with the aim of informing physicians on which patients would benefit from biopsy and where biopsy should be targeted. The study builds on the PRIMARY and PRIMARY2 studies, which demonstrated that combining 68Ga-PSMA-PET with MRI can improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by approximately 50%.

Telix recently completed enrolment in the Phase 3 BiPASS study. The company is engaged with the FDA on a New Drug Application (NDA) pathway, which would support registration as a new product and broaden access to 68Ga-PSMA-PET imaging for a substantially larger patient population than current approved indications cover. The pre-biopsy use of Illuccix and Gozellix remains investigational and has not been approved by the FDA or any other regulatory authority.

Fast Track Designation: Regulatory Implications

Fast Track is an FDA program designed to facilitate development and expedite review of therapies addressing serious conditions with unmet medical need. The designation facilitates more frequent interactions with the FDA during the development process and may enable the filing of a rolling NDA, allowing completed sections to be reviewed on a rolling basis. It does not guarantee approval.

More than three million prostate biopsies are performed globally each year, yet up to 75% produce a negative result. The FDA's granting of Fast Track designation reflects its recognition of the unmet need that a validated pre-biopsy imaging-first approach could address.

Commercial Context

Illuccix and Gozellix are currently approved for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis and in patients with suspected recurrence following elevated PSA levels. If a pre-biopsy NDA is approved, it would significantly extend the addressable use of Telix's existing 68Ga-PSMA-PET agents into the initial diagnostic workup — a substantially larger patient population than those currently covered by approved indications.

Key Takeaways

Telix Pharmaceuticals' BiPASS Fast Track designation marks a regulatory milestone for the company's effort to extend 68Ga-PSMA-PET imaging into the pre-biopsy prostate cancer setting. With Phase 3 enrolment complete and NDA pathway discussions with the FDA underway, the coming period will be defined by the submission timeline and the FDA's review of the BiPASS data package.

FAQs

Q: What is the FDA Fast Track designation for BiPASS?

A: The FDA granted Telix Pharmaceuticals Fast Track designation for BiPASS, a Phase 3 program evaluating 68Ga-PSMA-PET imaging with MRI for prostate cancer detection before biopsy, recognising it addresses an important unmet medical need.

Q: What is the BiPASS study?

A: BiPASS (Biopsy of the Prostate Avoidance Stratification Study) is a Phase 3 clinical trial evaluating Telix's Illuccix and Gozellix PSMA-PET agents in combination with MRI to help determine which patients need prostate biopsy and where it should be targeted.

Q: Does Fast Track designation mean BiPASS is approved?

A: No. Fast Track designation facilitates more frequent FDA engagement and may enable rolling NDA review, but it does not guarantee approval. The pre-biopsy use of Illuccix and Gozellix remains investigational.

Q: What is the NDA pathway Telix is pursuing?

A: Telix is engaging with the FDA on a New Drug Application pathway that would register a new product for pre-biopsy prostate cancer imaging, broadening approved use of its 68Ga-PSMA-PET agents beyond current indications.

Q: Why is the pre-biopsy prostate imaging setting clinically significant?

A: More than three million prostate biopsies are performed globally each year, with up to 75% producing negative results. An imaging-first approach using PSMA-PET and MRI could reduce unnecessary biopsies and improve early cancer detection.

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