Shares of Sagimet Biosciences (NASDAQ:SGMT) surged by 14.8% to $3.18 in premarket trading after the company announced that its drug, denifanstat, received the U.S. Food and Drug Administration's (FDA) "breakthrough therapy" designation.
This designation is intended to expedite the development and review process for drugs that target serious conditions or address unmet medical needs.
Denifanstat is being developed to treat noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a liver condition characterized by the excessive buildup of fat, leading to inflammation and fibrosis (scarring) of the organ.
The breakthrough therapy designation was granted based on promising results from a mid-stage clinical trial, where denifanstat demonstrated the ability to resolve MASH without worsening fibrosis—a key concern in the disease’s progression that can lead to liver dysfunction.
Despite the positive news, Sagimet’s share price has been down 48.9% year-to-date.