Sagimet Shares Rise Premarket on FDA Breakthrough Designation

By Colin Kellaher

Shares of Sagimet Biosciences rose more than 15% in premarket trading Tuesday after the clinical-stage biopharmaceutical company won Food and Drug Administration breakthrough-therapy designation for its lead drug candidate denifanstat in a chronic liver condition.

Sagimet said the designation covers denifanstat in patients with noncirrhotic metabolic dysfunction-associated steatohepatitis, also known as MASH, with moderate to advanced liver fibrosis.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Sagimet said it plans to initiate a Phase 3 clinical program for denifanstat in MASH by the end of the year.

Shares of the San Mateo, Calif., company, which closed Monday at $2.77, were recently up 16% to $3.21 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

October 01, 2024 08:23 ET (12:23 GMT)

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