Sangamo: ST-920 Phase 1/2 data positive; FDA agrees to Accelerated Approval path

SANGAMO THERAPEUTICS, INC

FDA agreed Phase 1/2 STAAR data can support Accelerated Approval using eGFR slope at 52 weeks; rolling BLA started Dec 2025.
Positive mean annualized eGFR slope of 1.965 at Week 52 (95% CI -0.153, 4.083) across 32 patients; Week 104 slope 1.747.
All 15 ERT-naïve patients achieved normal/supraphysiological α-Gal A activity up to 54 months; 18 ERT patients safely withdrew from ERT.
32 of 33 patients completed 52-week follow-up; ST-920 well-tolerated with no discontinuations due to AEs, no TMA or complement activation.
Statistically significant improvements in SF-36 QoL and GSRS diarrhea scores at Week 52; anti-α-Gal A antibodies reduced/eliminated in 9/10 patients.

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