Homepage > Company > Media > Pharma News > 2024 > Sagimet Soars: FDA Breakthrough Therapy Designation And Lancet Review Validate Denifanstat

Sagimet Soars: FDA Breakthrough Therapy Designation And Lancet Review Validate Denifanstat

Sagimet Biosciences' Denifanstat shows significant potential in treating MASH, with FDA Breakthrough Therapy designation and peer-reviewed validation, supporting a "Strong Buy" rating. Denifanstat's unique FASN inhibition mechanism effectively reduces liver fibrosis, positioning it as a superior treatment for advanced MASH compared to competitors like Tirzepatide.

SGMT's robust financials, including $188.5 million in liquidity and no debt, provide a solid foundation for advancing Denifanstat through Phase 3 trials.

Potential applications in dermatology and oncology, along with favorable safety profiles, enhance Denifanstat's market prospects and underscore SGMT's undervaluation.

Sagimet Biosciences Inc. has significantly improved recently. It’s now well-positioned as a potential leader in innovative therapies for metabolic dysfunction-associated steatohepatitis [MASH]. Moreover, SGMT might also soon unlock additional applications in dermatology and oncology. Since Strong Buy rating in July 2024, based on the successful results of Phase 2 for Denifanstat, SGMT has continued advancing its clinical profile.

Denifanstat is a fatty acid synthase [FASN] inhibitor that directly addresses lipid accumulation in the liver, effectively reducing fibrosis in MASH patients. Because of this, the FDA gave Denifanstat a Breakthrough Therapy designation in October 2024, and a peer review further validated its potential. SGMT is also working on a Denifanstat application for acne with Phase 3 interim data for recurrent glioblastoma multiforme [rGBMP] anticipated by yearend 2024. In my view, SGMT’s FASN inhibitory IP and MASH potential, coupled with a robust balance sheet, make it a “Strong Buy” even after its recent share price appreciation.

Sagimet Biosciences is a biotechnology company that continues developing its MASH medicine, which could eventually have applications in dermatology and oncology. In July 2024, I rated SGMT as a “Strong Buy” due to its positive results from Denifanstat’s Phase 2b clinical trials, which showed impressive efficacy through its unique mechanism of action. This medicine is a fatty acid synthase [FASN] inhibitor that treats metabolic dysfunction-associated steatohepatitis [MASH], a disease with limited treatment alternatives and increasing prevalence.

Read also

Chengdu Baiyu enters into a license agreement for the development and commercialization of its Anti-tumor small molecule inhibitor

Chengdu Baiyu Pharmaceutical Co., Ltd. (Chengdu, China) announced that it has entered into an exclusive license agreement with Novartis for a small molecule anti-tumor asset.

Intercept’s liver disease drug Ocaliva faces FDA approval delay

An FDA AdCom in September recommended against full approval for Ocaliva (obeticholic acid) by a 13-1 vote for the treatment of primary biliary cholangitis. The original FDA full approval decis...

Rani Therapeutics shares hold buy rating on positive preclinical data

On Thursday, Rani Therapeutics Holdings Inc. shares maintained a positive outlook as H.C. Wainwright reaffirmed a Buy rating with a $9.00 price target.

Rectify Pharmaceuticals to Present New Preclinical Data at The American Association for the Study of Liver Diseases Annual Meeting

Rectify Pharmaceuticals, Inc., a biotechnology company developing positive functional modulators (PFMs), small molecule therapeutics that restore and enhance membrane protein function, today a...