Telix Pharmaceuticals Ltd ADR (NASDAQ: TLX) shares advanced 5.3% in premarket trading on Wednesday following the completion of its Phase 3 BiPASS trial and alignment with the U.S. Food and Drug Administration on a New Drug Application pathway.
H.C. Wainwright analyst Robert Burns maintained a Buy rating on the stock with a $20 price target, citing the trial’s progress as a key catalyst. The BiPASS trial enrolled 350 patients to evaluate the combined use of Illuccix and Gozellix with MRI imaging against the standard of care for detecting prostate cancer.
The company’s regulatory strategy includes pursuing an FDA New Drug Application pathway for the BiPASS trial. If approved, the designation would support reimbursement as a new product and expand patient access to the diagnostic tools. The trial’s completion marks a significant milestone in Telix’s efforts to address gaps in current prostate cancer diagnostics.
Prostate cancer diagnosis remains a challenge under existing protocols. Men with elevated prostate-specific antigen levels often undergo MRI scans, which frequently yield inconclusive results. The standard next step is a prostate template biopsy, involving 12 to 20 needle insertions, even for patients deemed low risk. However, this procedure can miss significant cancers, cause discomfort, and carry procedural risks.
Industry data highlights the scale of the issue. More than 1 million biopsies are performed annually in the U.S., with up to 75% returning negative results. Additionally, approximately one in four patients refuse a recommended biopsy, underscoring the need for more reliable diagnostic alternatives.
