Sangamo Therapeutics Aligns with FDA for Accelerated Approval of ST-920 Gene Therapy for Fabry Disease by 2025

Oct 22, 2024, 12:12 PM

Sangamo Therapeutics announced that it has reached an agreement with the U.S. FDA on an Accelerated Approval pathway for its ST-920 gene therapy product candidate for the treatment of Fabry disease. This alignment is expected to accelerate the potential approval timeline by approximately three years, with a Biologics License Application (BLA) submission anticipated in the second half of 2025. The FDA's decision is a significant step forward for Sangamo's efforts in addressing this rare disease.