SGMT Stock Up 12.6% on FDA Fast Track for Liver Disease Drug

Company Overview - Sagimet Biosciences' stock increased by 12.6% following the FDA's breakthrough therapy designation for its lead candidate, denifanstat, aimed at treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1] - Denifanstat is an oral, once-daily pill that has shown statistically significant fibrosis reduction and delay in progression to cirrhosis in patients with moderate-to-advanced liver fibrosis [3] - Sagimet plans to initiate a phase III program for denifanstat by the end of 2024 [3] Industry Context - MASH, also known as nonalcoholic steatohepatitis (NASH), affects over 115 million people globally and can lead to severe liver conditions, creating a significant need for new therapies [6] - Currently, the only approved treatment for MASH is Madrigal Pharmaceuticals' Rezdiffra, which was launched in April 2023 [5] - The market for MASH is largely untapped, with several companies, including Viking Therapeutics, Akero Therapeutics, Eli Lilly, and Novo Nordisk, developing treatments for NASH/MASH [7][8][9]