Sagimet: denifanstat hits 56.7% IGA success at 52 weeks in Ascletis Phase 3 OLE; US AURORA screening starts October

Sagimet Biosciences Inc.

52-week Phase 3 OLE (ASC40-304) in China: 56.7% treatment success across 240 patients (57.8% denifanstat/denifanstat vs 55.6% placebo/denifanstat).
Mean reductions vs ASC40-303 baseline: total lesion count -71.8%, inflammatory lesions -76.9%, non-inflammatory lesions -66.9%.
Denifanstat 50 mg was generally well-tolerated up to 52 weeks: no permanent discontinuations or drug-related serious AEs; dry skin 7.1%, dry eye 5.9%.
Sagimet's US AURORA Phase 3 screening begins October 2026: ~800 patients (450 aged 12-17), randomized 2:1 to denifanstat 50 mg or placebo over 12 weeks.
Sagimet terminated the ATM prospectus supplement under its Aug 14, 2025 Sales Agreement with Leerink Partners; no further share sales unless a new prospectus is filed.

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