一次情報の記録
決定級トップライン結果
Sagimet:FASCINATE-2 第2b相、denifanstatのMASHデータ
The 8-K exhibit presents the full FASCINATE-2 Phase 2b topline biopsy results for denifanstat in F2/F3 MASH, confirming both primary endpoints were met with statistical significance (NAS ≥2 improvement without fibrosis worsening: 38% vs 16%; MASH resolution + NAS ≥2: 26% vs 11%) and a key secondary endpoint of fibrosis improvement ≥1 stage without MASH worsening (41% vs 18%). These data, previously announced in 1Q2024, are now formally disclosed in an SEC filing, establishing the regulatory path for Phase 3 advancement.
主要事実
- 提出
- 2025年10月23日 20:06
- イベント
- トップライン結果
- 方向
- ポジティブ
- アセット
- denifanstat
- 出典
- SEC 8-K
- 信頼度
- 出典あり
- 第2b相 MASH消退率
- 26% vs 11%
- 第2b相 NASスコア改善
- 38% vs 16%
- 第2b相 線維化改善
- 41% vs 18%
出典の抜粋
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