Sangamo Therapeutics Initiates Rolling Submission Of BLA To FDA Seeking Accelerated Approval Of Isaralgagene Civaparvovec, Or ST-920, Investigational Gene Therapy For Treatment Of Adults With Fabry Disease

STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as an endpoint to support accelerated approval pathway 

Isaralgagene civaparvovec continues to show favorable safety and tolerability profile

Sangamo expects to complete Biological License Application (BLA) submission under accelerated approval pathway in second quarter of 2026
 

RICHMOND, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (NASDAQ:SGMO), a genomic medicine company, has initiated a rolling submission of a BLA to the FDA seeking accelerated approval of isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease.

Rolling submission allows for completed modules of the BLA to be submitted and reviewed by the FDA on an ongoing basis rather than waiting for the entire BLA to be submitted at once.