MELBOURNE and INDIANAPOLIS - Telix Pharmaceuticals Limited (ASX:TLX, NASDAQ: TLX) announced Tuesday that its IPAX-2 study of TLX101-Tx in patients with newly diagnosed glioblastoma has completed patient enrollment. The biopharmaceutical company, valued at $3.46 billion, has demonstrated strong revenue growth of 56% over the last twelve months as of Q4 2025, though it remains unprofitable as it advances its clinical pipeline.
The company stated that no dose-limiting toxicities have been observed to date, including at the maximum administered dose of 10GBq total activity.
IPAX-2 is a Phase 1 dose-finding study evaluating the safety and tolerability of TLX101-Tx combined with post-surgical standard-of-care treatment in primary glioblastoma. Twelve patients were enrolled across three dose-escalating cohorts at four sites in Australia, Austria and the Netherlands. The study aims to assess the maximum tolerated dose for further development.
TLX101-Tx is a systemically administered radiopharmaceutical therapy targeting L-type amino acid transporter 1, which is typically over-expressed in glioblastoma. The treatment uses a small molecule approach designed to cross the blood-brain barrier.
The therapy is also being evaluated in the IPAX BrIGHT pivotal trial, which is assessing TLX101-Tx combined with lomustine compared to chemotherapy alone in patients with recurrent glioblastoma. The trial is actively enrolling patients in Australia and the Netherlands, with enrollment to begin soon in Austria and Belgium.
Despite the company’s lack of current profitability, investors have shown confidence in its clinical progress, with the stock delivering a 41% return year-to-date. Analysts maintain a Strong Buy consensus rating on the shares, with price targets suggesting significant upside potential.
Glioblastoma is the most common and aggressive form of primary brain cancer, with approximately 22,000 new cases diagnosed annually in the U.S. Despite treatment comprising surgical resection, radiotherapy and chemotherapy, recurrence occurs in almost all patients, with expected survival of 12-15 months from diagnosis.
TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. The therapy has not received marketing authorization in any jurisdiction and remains investigational.
