Sagimet：FASCINATE-2 第二期 2b 期 denifanstat MASH 數據

8-K 附件呈現 denifanstat 用於 F2/F3 MASH 的完整 FASCINATE-2 第二期 2b 期頂線肝活檢結果，確認兩項主要終點均達到統計學顯著性（NAS 改善 ≥2 分且纖維化未惡化：38% vs 16%；MASH 緩解 + NAS 改善 ≥2 分：26% vs 11%），以及一項關鍵次要終點（纖維化改善 ≥1 期且 MASH 未惡化：41% vs 18%）。這些先前於 2024 年第一季公布的數據，現已正式揭露於 SEC 申報文件，確立第三期推進的法規路徑。

關鍵事實

申報時間: 2025年10月23日下午08:06
事件: 主要結果 (Topline)
方向: 正面
公司: SGMTSagimet Biosciences
資產: denifanstat
來源: SEC 8-K
可信度: 有出處
2b 期 MASH 緩解率: 26% 對 11%
2b 期 NAS 改善率: 38% 對 16%
2b 期纖維化改善率: 41% 對 18%

來源摘錄

EX-99.1 2 tm2529317d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Targeting MetabolicDysfunction with Novel Therapies to Treat MASH, Acne&Cancer October 2025 October 2025 2 Forward-Looking Statements and Disclaimer This presentation contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this document, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding possible or assumed future results of operations, business strategies, research and development plans, regulatory activities, the presentation of data from clinical trials, Sagimet’s clinical development

SEC 8-K