Sagimet’s positive PhIIb NASH data; FDA lifts hold on Pharvaris IND; Dianthus raises $230M
Plus, news about ORIC Pharmaceuticals, Alector and CalciMedica:
NASH heats up: Sagimet Biosciences’ stock $SGMT surged more than 130% on Monday morning following a positive Phase IIb readout for its NASH hopeful, denifanstat. NASH, or nonalcoholic steatohepatitis, is also referred to as metabolic dysfunction-associated steatohepatitis (MASH), and it’s caused by fat buildup in the liver that leads to inflammation and fibrosis. Denifanstat met both primary endpoints and a handful of secondary endpoints among 168 NASH patients with stage 2 or 3 fibrosis, setting plans in motion for a Phase III launch in the second half of this year. However, treatment-emergent adverse events caused nearly 20% of patients taking denifanstat to discontinue treatment, compared to about 5% of placebo patients. Madrigal’s resmetirom is nearing a March PDUFA date for what could be the first FDA approval of a NASH drug following years of failure. — Nicole DeFeudis
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