Sangamo Therapeutics Biologics License Application Gets FDA's Acceptance For Isaralgagene Civaparvovec To Treat Fabry Disease

Sangamo Therapeutics, Inc. (NASDAQ:SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has accepted Sangamo's request for a rolling submission and review of the Biologics License Application (BLA) for isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease.

This acceptance follows Sangamo's meeting with the FDA in October 2025 to discuss the proposed efficacy and safety data package for isaralgagene civaparvovec where, in the meeting minutes, among other things, the FDA reiterated its October 2024 agreement to use eGFR slope as an endpoint to support an accelerated approval pathway.