Sagimet: Datos ng Phase 2b FASCINATE-2 ng denifanstat para sa MASH

Ang 8-K exhibit ay nagpapakita ng buong FASCINATE-2 Phase 2b topline biopsy results para sa denifanstat sa F2/F3 MASH, na nagpapatunay na ang parehong primary endpoints ay natugunan nang may statistical significance (NAS ≥2 improvement nang walang fibrosis worsening: 38% vs 16%; MASH resolution + NAS ≥2: 26% vs 11%) at isang key secondary endpoint ng fibrosis improvement ≥1 stage nang walang MASH worsening (41% vs 18%). Ang mga datos na ito, na dating inihayag noong 1Q2024, ay ngayon ay pormal na isiniwalat sa isang SEC filing, na nagtatatag ng regulatory path para sa Phase 3 advancement.

Mahahalagang fact

Na-file: Okt 23, 2025, 08:06 PM
Kaganapan: Topline na resulta
Direksyon: Positibo
Kumpanya: SGMTSagimet Biosciences
Asset: denifanstat
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Paglutas ng MASH sa Phase 2b: 26% kumpara sa 11%
Pagpapabuti ng NAS sa Phase 2b: 38% kumpara sa 16%
Pagpapabuti ng fibrosis sa Phase 2b: 41% kumpara sa 18%

Sipi mula sa source

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