Denifanstat

Sagimet Biosciences reported Q3 2024 financial results and updates, including FDA's Breakthrough Therapy designation for denifanstat in MASH treatment, publication of Phase 2b FASCINATE-2 study results in The Lancet, and successful end-of-Phase 2 FDA interactions. The company plans to initiate Phase 3 program by end of 2024, with $170.0 million in cash and equivalents as of September 30, 2024, and a Q3 net loss of $14.6 million.

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Sagimet Biosciences plans to launch two Phase 3 trials for its oral therapy denifanstat in people with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), with trials expected to start by year-end. Denifanstat, designed to block the fatty acid synthase enzyme, aims to reduce liver fat buildup and improve liver health. The trials, supported by the FDA, will assess safety and efficacy in MASLD/MASH patients.

Sagimet Biosciences advances denifanstat, an FASN inhibitor, into Phase III trials for treating MASH, with FDA support. The Phase III program includes FASCINATE-3 and FASCINIT trials, aiming to assess efficacy and safety in MASH and MASLD patients.