Telix Pharmaceuticals receives FDA Fast Track status

• Telix Pharmaceuticals earned U.S. FDA Fast Track designation for its BiPASS prostate cancer imaging programme.
• The regulatory milestone enhances potential expedited review for the company's upcoming planned drug application submission.
• BiPASS combines gallium-68 PSMA-PET imaging with MRI to reduce unnecessary biopsies by almost 50%.

Telix Pharmaceuticals (ASX:TLX) announced that the U.S. Food and Drug Administration granted a Fast Track designation for its BiPASS prostate cancer imaging programme.

The regulatory programme accelerates development and review timelines compared to standard review pathways for drugs addressing unmet medical needs.

"The fast track designation reflects the FDA’s recognition of the potential for BiPASS to address an important need in the prostate cancer diagnostic pathway," said Telix Group Chief Medical Officer Dr David N. Cade.

More than three million prostate biopsies are performed globally each year, but up to 75% produce a negative result.

Following the announcement, the Telix Pharmaceuticals share price was unchanged at $16.15.

The BiPASS study evaluates Ga-PSMA-PET agents Illuccix and Gozellix alongside MRI scans prior to biopsy.

Telix recently finished enrolment for its Phase 3 BiPASS study as it prepares its next drug application submission.