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0 0.0575539568345323 0.0827338129496403 0.0827338129496403 0.147482014388489 0.107913669064748 0.179856115107914 0.294964028776978
Stock impact report

Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH

Sagimet Biosciences Inc. (SGMT) 
Company Research Source: GlobeNewswire
Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH Preparations are ongoing to initiate Phase 3 program for denifanstat by the end of 2024 SAN MATEO, Calif., Oct. 01, 2024 (GLOBE NEWSWIRE) --  Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to denifanstat for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). “The FDA’s Breakthrough Therapy designation for denifanstat underscores the global incidence of MASH and the continuing need for new therapies,” said David Happel, Chief Executive Officer of Sagimet. “As the only fat synthesis inhibitor that directly targets the three main driv Show less Read more
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