Telix Completes Enrollment in Pivotal BiPASS Trial, FDA Aligns on NDA Path
TLX sits 74% above its 52-week low of $6.28.
Summary
Telix finished enrolling 350 patients in its Phase 3 BiPASS study of Illuccix and Gozellix for pre-biopsy prostate cancer imaging. The company also aligned with the FDA on an NDA pathway that, if approved, would support reimbursement as a new product and broaden access to 68Ga-PSMA-PET imaging. This is the first registrational study in the pre-biopsy setting, building on PRIMARY and PRIMARY2 data showing the combination can halve unnecessary biopsies. The milestone expands Telix's addressable market beyond staging and recurrence into initial diagnosis. Watch for top-line BiPASS data and the NDA submission timing.
At the time of this announcement, TLX was trading at $10.90 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $3.7B. The 52-week trading range was $6.28 to $12.48. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: PR Newswire.