Telix Advances Key Prostate Cancer Diagnostic to Phase 3 in U.S.
Company doses first American patient in its BiPASS study, a pivotal trial aimed at improving diagnostic accuracy and reducing unnecessary biopsies.
Telix Pharmaceuticals (NASDAQ: TLX) has initiated a critical new phase in its push to refine prostate cancer diagnosis, announcing Friday it has dosed the first U.S. patient in its pivotal Phase 3 'BiPASS' clinical trial. The study evaluates the effectiveness of its advanced imaging agent, Illuccix, in a field where diagnostic certainty is a paramount concern.
Investors reacted positively to the milestone, which marks significant progress for a key asset in the biotechnology firm's pipeline. Shares of Telix climbed approximately 4.7% to $7.78 in Friday trading, signaling confidence in the company's clinical development strategy. The Australian-based company, which holds a market capitalization of roughly $3.27 billion, is focused on the development and commercialization of radiopharmaceuticals.
The BiPASS study is designed to determine if combining PSMA-PET/CT imaging, performed with Telix’s Illuccix agent, with a standard MRI can help men with suspected prostate cancer avoid painful and often unnecessary biopsies. According to a company press release, success in this trial could expand the potential U.S. market for its imaging agents by an estimated 800,000 scans annually.
"The initiation of this study is a crucial step towards potentially establishing a new standard of care in prostate cancer diagnosis," said Dr. Christian Behrenbruch, Managing Director and Group CEO of Telix, in a statement. The goal is to provide a non-invasive method that offers greater clarity before a patient undergoes a biopsy, a procedure that carries its own risks and discomfort.
Telix is navigating a large and growing market. The global prostate cancer diagnostics sector was valued at over $5.5 billion in 2025 and is projected to exceed $6 billion in 2026, driven by rising prevalence and technological advancements. While the field includes diagnostic giants like Siemens Healthineers and Abbott Laboratories, Telix has carved out a specialized niche in radiopharmaceuticals, positioning itself as an innovator in molecular imaging.
Wall Street has maintained a bullish outlook on the company's prospects. According to data from MarketBeat, Telix holds a strong consensus 'Buy' rating from analysts. The average 12-month price target sits near $21, suggesting a significant potential upside from its current trading levels. This optimism is built on the commercial success of Illuccix in its currently approved indications and the promise of pipeline candidates like the one being tested in the BiPASS trial.
Despite a challenging year that has seen its stock trade in a wide range between $7.31 and $30.36, the advancement of the BiPASS study provides a tangible long-term catalyst for investors. The successful completion of this Phase 3 trial and subsequent regulatory approvals would not only expand Illuccix's label but also solidify Telix's position as a key player in the future of oncology diagnostics.