Welcome to our dedicated page for Sangamo Therapeutics SEC filings (Ticker: SGMO), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
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Sangamo Therapeutics (SGMO) reported positive topline data from its registrational Phase 1/2 STAAR study of isaralgagene civaparvovec (ST-920) for Fabry disease. In 32 treated adults, a single infusion produced a mean annualized eGFR slope of +1.965 mL/min/1.73 m²/year at 52 weeks, contrasting with published slopes of -2.2 to -0.4 mL/min for current standard therapies. Among 19 patients with 104-week follow-up, the slope remained positive at +1.747 mL/min, the FDA-endorsed intermediate endpoint for Accelerated Approval.
Secondary outcomes were uniformly favorable. All 18 patients initially on enzyme-replacement therapy discontinued ERT and remained off treatment, while plasma lyso-Gb3, cardiac parameters and α-Gal A activity stayed stable or improved for up to 4.5 years. Patient-reported outcomes showed statistically significant gains across multiple SF-36 domains and reductions in gastrointestinal symptoms, pain-medication use and anhidrosis.
Safety profile appeared benign: most adverse events were grade 1-2; no pre-conditioning, no safety-related discontinuations. The most common TEAEs were pyrexia (60.6%), COVID-19 (36.4%), headache (33.3%) and nasopharyngitis (33.3%).
The dataset supports SGMO’s plan to file a BLA under the Accelerated Approval pathway as early as Q1 2026. ST-920 already holds Orphan Drug, Fast Track and RMAT designations, plus EU and UK incentives. Full analyses will be presented at a future conference, and management is pursuing a commercialization partnership.