In an ASX announcement dated 30 September 2026, Telix Pharmaceuticals Limited (ASX:TLX) stated that the FDA had granted Fast Track Designation for its BiPASS program. The release was issued from Melbourne and Indianapolis and also references the company’s Nasdaq listing under the same ticker. Telix describes itself as a commercial-stage global radiopharmaceutical company focused on targeted theranostics, which pairs a precision diagnostic with a targeted therapy.

This article summarises the contents of that announcement, sets out the surrounding sector backdrop, notes risks that the company itself flags, and outlines the next steps described in the release.

Press Release Details

BiPASS, short for Biopsy of the Prostate Avoidance Stratification Study, is evaluating gallium-68 PSMA-PET imaging in combination with MRI for the detection of prostate cancer before a biopsy is performed. The study is registered on ClinicalTrials.gov under the identifier NCT07052214. According to the announcement, the Fast Track designation recognises the program’s potential to address an important unmet need by enabling an imaging-first approach to initial prostate cancer diagnosis.

Telix explained that Fast Track is an FDA process designed to facilitate the development and expedite the review of drugs that treat serious conditions and Fill an unmet medical need. The release says the designation facilitates more frequent engagement with the FDA and may enable expedited review of the planned NDA. The company cited published literature indicating that more than three million prostate biopsies are performed globally each year and that up to 75 per cent of them produce a negative result.

The company reported that it has recently completed enrolment in the Phase 3 BiPASS study of its proprietary gallium-68 PSMA-PET agents, Illuccix and Gozellix, for pre-biopsy prostate cancer diagnosis. Telix said it has engaged positively with the FDA on an NDA pathway and is planning its submission. The release states that the NDA pathway supports registration as a new product which, if approved, would broaden access to PSMA-PET imaging for a substantially larger patient population.

BiPASS builds on the PRIMARY and PRIMARY2 studies. The announcement says those studies demonstrated that combining PSMA-PET imaging with MRI can significantly improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50 per cent. Telix clarified that BiPASS is not intended to replace biopsy when it benefits the patient. Instead, the program aims to help clinicians determine which patients would benefit from biopsy and where biopsy should be targeted.

Dr David N. Cade, Group Chief Medical Officer at Telix, said the designation supports continued close engagement with the FDA as the company advances BiPASS toward an NDA submission.

The release also restates the current regulatory position of the company’s products. Illuccix and Gozellix are approved for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, and in patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels. Illuccix is also approved for the selection of patients indicated for PSMA-directed therapy. Telix states that use of Illuccix and Gozellix in the pre-biopsy setting remains investigational and has not been approved by the FDA or any other regulatory authority.

Sector Backdrop

Radiopharmaceuticals combine a radioactive isotope with a molecule that targets specific tissue, and the field spans both diagnostic imaging and targeted therapy. Prostate-specific membrane antigen (PSMA) imaging with positron emission tomography has become an established tool in prostate cancer care, and several PSMA-targeted imaging agents are already marketed in the United States, including products from other developers.

Current approvals for PSMA-PET agents generally centre on staging in patients with suspected metastasis and on evaluating suspected recurrence. Pre-biopsy use is a different clinical setting, and as the Telix release notes, it remains investigational. Regulators typically assess a new indication through clinical evidence and a formal application, which is the stage the company says it is working toward.

Risks Shareholders Should Weigh

The announcement is explicit that there are limits to what the designation means. Fast Track facilitates engagement and may enable expedited review, but it does not guarantee that an NDA will be submitted, accepted or approved. The release also confirms that pre-biopsy use of Illuccix and Gozellix has not been approved by the FDA or any other regulatory authority.

Telix’s forward-looking statements section lists several areas of uncertainty. These include the timing, progress, completion and results of clinical trials, the timing and likelihood of regulatory filings and approvals, Manufacturing and Supply capabilities, and the pricing and reimbursement of products if and after they are approved. The company also refers to the anticipated effect of tariffs and wider macroeconomic conditions, and directs readers to its risk factors in its ASX and SEC filings.

What’s Next

According to the announcement, Telix is planning its NDA submission for the pre-biopsy indication and says the Fast Track designation supports continued close engagement with the FDA as it advances toward that filing. The company has already completed enrolment in the Phase 3 BiPASS study. No submission date, approval timeline or financial effect is quantified in the release.