Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH
Sagimet Biosciences Inc. (SGMT)
Company Research
Source: GlobeNewswire
Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH Preparations are ongoing to initiate Phase 3 program for denifanstat by the end of 2024 SAN MATEO, Calif., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to denifanstat for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). “The FDA’s Breakthrough Therapy designation for denifanstat underscores the global incidence of MASH and the continuing need for new therapies,” said David Happel, Chief Executive Officer of Sagimet. “As the only fat synthesis inhibitor that directly targets the three main driv
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SGMT
News
- Sagimet Biosciences Announces Upcoming Presentations at AASLD - The Liver Meeting® 2024GlobeNewswire
- Sagimet Biosciences Announces Publication of Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 MASH in The Lancet Gastroenterology & HepatologyGlobeNewswire
- Sagimet Biosciences Inc. (NASDAQ: SGMT) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $32.00 price target on the stock.MarketBeat
- Sagimet soars on FDA breakthrough therapy designation for its liver disease treatment [Seeking Alpha]Seeking Alpha
- Sagimet Biosciences to Present at the H.C. Wainwright 8th Annual MASH Virtual Conference and Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) [Yahoo! Finance]Yahoo! Finance
SGMT
Earnings
- 8/14/24 - Beat
SGMT
Sec Filings
- 8/27/24 - Form EFFECT
- 8/16/24 - Form 8-K
- 8/15/24 - Form S-3
- SGMT's page on the SEC website