Sagimet Biosciences Inc. (SGMT) Tuesday said the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to denifanstat for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis.
Breakthrough therapy designation of denifanstat was supported by positive data from the Phase 2b FASCINATE-2 study in biopsy-confirmed MASH patients with stage 2 or stage 3 fibrosis.
The company plans to initiate a Phase 3 study of denifanstat in MASH by the end of 2024.
Drugs that receive breakthrough therapy designation are eligible for all the benefits of fast track designation, as well as intensive guidance by FDA on an efficient drug development program and organizational commitment involving FDA senior managers.
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Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.