Civaparvovec (ST-920) - (STAAR)

March 9, 2026: Sangamo Therapeutics, Inc. (NASDAQ: SGMO) announced progress in its rolling BLA submission to the FDA seeking accelerated approval of isaralgagene civaparvovec (ST-920), a wholly owned investigational one-time gene therapy for adults with Fabry disease. The company has now submitted the preclinical and clinical modules for FDA review, following initiation of the rolling submission in December 2025.

Sangamo also reported that an antibody assay companion diagnostic to screen patient eligibility for ST-920 has been submitted to and accepted by the FDA’s Center for Devices and Radiological Health (CDRH) for Premarket Approval (PMA).

Regulatory/clinical support: In the registrational Phase 1/2 STAAR study (global, open-label, single-dose, dose-ranging, multicenter), the company said the study showed a positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52 weeks across all dosed patients, and that the FDA has agreed this 52-week eGFR slope will serve as an endpoint to support an accelerated approval pathway. Data were presented at the 22nd Annual WORLD Symposium.