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Promising Phase 2b Results Propel Sagimet Biosciences’ Denifanstat Towards Pivotal Phase 3 Trial
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Promising Phase 2b Results Propel Sagimet Biosciences’ Denifanstat Towards Pivotal Phase 3 Trial

Sagimet Biosciences, Inc. Class A (SGMTResearch Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Ed Arce from H.C. Wainwright maintained a Buy rating on the stock and has a $32.00 price target.

Ed Arce’s rating is based on a number of promising developments in Sagimet Biosciences’ clinical trials and the potential of their lead drug candidate, denifanstat. The company recently announced strong results from the Phase 2b FASCINATE-2 trial, which demonstrated significant improvements in patients with moderate-to-severe fibrosis due to NASH. Denifanstat met both primary endpoints with a high degree of statistical significance, and also achieved success in key secondary endpoints that are now recognized as registrational by regulatory authorities. This sets a solid foundation for the upcoming Phase 3 trial, which is expected to begin in the second half of 2024, post an End-of-Phase 2 meeting with the FDA.
Furthermore, the drug’s efficacy was supported by additional analyses, including AI-based digital pathology and reductions in non-invasive biomarkers that indicate anti-fibrotic benefits. Denifanstat also showed a rapid and progressive reduction in relative liver fat, and improvements in liver injury biomarkers. Although there were mixed results in lipid assessments, the decrease in harmful lipotoxins suggests a positive impact on lipid metabolism. These compelling clinical outcomes, combined with the drug’s unique mechanism of action, contribute to the Buy rating and the anticipation of the detailed design of the pivotal Phase 3 trial, which is expected to be a critical milestone for Sagimet Biosciences.

Based on the recent corporate insider activity of 29 insiders, corporate insider sentiment is positive on the stock. This means that over the past quarter there has been an increase of insiders buying their shares of SGMT in relation to earlier this year.

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Sagimet Biosciences, Inc. Class A (SGMT) Company Description:

Sagimet Biosciences Inc., a clinical-stage biopharmaceutical company, develops therapeutics called fatty acid synthase (FASN) inhibitors for the treatment of diseases that result from dysfunctional lipid metabolism pathways. Its lead drug candidate is Denifanstat, a FASN inhibitor for the treatment of nonalcoholic steatohepatitis and acne. The company is also developing TVB-3567, a FASN inhibitor for the treatment of various types of cancers. The company was formerly known as 3-V Biosciences, Inc. and changed its name to Sagimet Biosciences Inc. in August 2019. Sagimet Biosciences Inc. was incorporated in 2006 and is headquartered in San Mateo, California.

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