Telix Completes BiPASS Enrollment, Secures FDA NDA Path

An NDA pathway confirmation from the FDA signals that Telix Pharmaceuticals' 68Ga-PSMA-PET kit manufacturing operations, and those of any contract manufacturer supporting Illuccix® or Gozellix®, will need to demonstrate GMP-compliant scalability well ahead of a formal submission. Telix announced on September 2, 2026 that the Phase 3 BiPASS™ study has completed enrollment of 350 patients across the U.S. and Australia, and that the company has aligned with FDA on a New Drug Application pathway for the pre-biopsy prostate cancer imaging indication.

BiPASS (Biopsy of the Prostate Avoidance Stratification Study) is the first registrational trial of 68Ga-PSMA-PET in the pre-biopsy setting. The prospective, open-label study evaluates whether combining MRI with PSMA-PET/CT using Telix's proprietary agents can improve diagnostic accuracy, reduce unnecessary biopsies, or improve biopsy targeting versus current standard practice. The clinical rationale is substantial: globally, more than three million prostate biopsies are performed annually, with up to 75% returning negative results.

For radiopharmaceutical manufacturing leads, the NDA designation carries specific process validation implications. Unlike a supplemental Biologics License Application, an NDA submission under 21 CFR Part 211 requires comprehensive chemistry, manufacturing, and controls documentation calibrated to commercial-scale production. Kit-based 68Ga-PSMA agents present particular GMP challenges around radiolabeling consistency, eluate quality specifications, and sterility assurance across distributed synthesis sites. Any expansion of the indicated patient population, which an NDA approval would enable, directly pressures production throughput and site qualification timelines.

The BiPASS program builds on the PRIMARY and PRIMARY2 studies, which showed that combining 68Ga-PSMA-PET with MRI can reduce unnecessary biopsies by approximately 50 percent without missing clinically significant prostate cancer. If BiPASS meets its primary endpoints, Telix intends to submit the combined dataset as the evidentiary basis for the NDA, potentially repositioning 68Ga-PSMA-PET from its current staging and restaging indications into first-line diagnostic use. That shift would represent a material increase in demand volume for approved manufacturing sites.

Reimbursement access is explicitly tied to the NDA outcome. Telix has stated that approval under this pathway would support new product reimbursement classification, a designation that carries different coding and coverage implications than the existing approved indications for Illuccix and Gozellix. QA and regulatory affairs teams at sites currently supplying these kits should track the NDA submission timeline against their process validation schedules and site master file currency.

The next measurable checkpoint is topline data readout from BiPASS, which will determine whether the NDA submission proceeds and at what scale Telix's manufacturing network must be prepared to respond.

Source: Telix Pharmaceuticals Limited via telixpharma.com, September 2, 2026.