The FDA has granted breakthrough therapy designation to Sagimet Biosciences’ denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis. The designation is based on positive results from the phase 2b FASCINATE-2 trial, showing significant improvements in MASH resolution, liver fibrosis, and fat reduction.
FDA grants breakthrough status to Sagimet’s denifanstat to treat MASH with fibrosis (Healio)
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