Australian Biotech's Novel Antibody-Based PSMA Therapy
ProstACT - Telix Pharmaceuticals Enters Pivotal Trial Phase, Challenging Pluvicto's $1.4 Billion Market BLUF (Bottom Line Up Front) Telix Pharmaceuticals has advanced its investigational prostate cancer treatment TLX591 into the randomized expansion phase of a global Phase 3 trial, marking the first study to combine an antibody-based PSMA radioligand with standard therapies from the outset. The Australian company is positioning this antibody approach—which offers potentially reduced side effects and simpler dosing versus Novartis's blockbuster Pluvicto—to capture a share of the rapidly expanding radioligand therapy market. With U.S. sites now enrolling patients and preliminary safety data forthcoming, TLX591 enters a competitive landscape where Pluvicto generated $1.39 billion in 2024 sales and recently secured FDA approval for earlier-line use. The trial's outcome could determine whether antibody-based radioligand therapy can challenge the dominance of small-molecule ap...