Sagimet receives FDA breakthrough therapy designation for denifanstat in MASH

Sagimet Biosciences

1 October 2024 - Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH.

Sagimet Biosciences today announced that the US FDA granted breakthrough therapy designation to denifanstat for treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

Read Sagimet Biosciences press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track