Denifanstat

The phase 2b FASCINATE-2 trial of denifanstat in MASH patients with stage 2 or 3 fibrosis showed significant improvements in disease activity, MASH resolution, and fibrosis. Published in The Lancet Gastroenterology and Hepatology, the study demonstrated denifanstat's effectiveness on primary endpoints: MASH resolution without fibrosis worsening and NAS reduction without fibrosis worsening. Denifanstat, an oral FASN inhibitor, targets fat accumulation, inflammation, and fibrosis, key drivers of MASH, and received FDA Breakthrough Therapy Designation for noncirrhotic MASH with moderate to advanced fibrosis.

The FDA granted breakthrough therapy designation to Boehringer Ingelheim’s survodutide for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate or advanced fibrosis. Two global phase 3 trials, LIVERAGE and LIVERAGE-Cirrhosis, will assess survodutide’s safety and efficacy. The trials aim to determine if survodutide can improve MASH and fibrosis, and reduce the risk of end-stage liver disease.

The FDA granted breakthrough therapy designation to Sagimet Biosciences' denifanstat, an oral therapy for MASH patients with moderate to advanced liver fibrosis. Denifanstat, which blocks a fat-producing protein in the liver, showed superiority to placebo in resolving MASH without worsening fibrosis in Phase 2b trials. Sagimet plans to launch a Phase 3 trial by year's end.

FDA grants breakthrough status to Sagimet’s denifanstat for treating MASH with fibrosis, based on positive phase 2b FASCINATE-2 trial data showing significant improvements in liver histology and fibrosis.

The FDA granted breakthrough therapy designation to Sagimet Biosciences' denifanstat for treating noncirrhotic MASH with moderate to advanced liver fibrosis, based on positive phase 2b FASCINATE-2 trial results showing 36% disease resolution and 41% fibrosis improvement with denifanstat vs. 13% and 18% with placebo, respectively.

Sagimet Biosciences' SGMT stock rose 12.6% after FDA granted breakthrough therapy designation to denifanstat for treating MASH, a severe liver disease. Denifanstat, an oral pill, showed significant fibrosis reduction and delay in cirrhosis progression in phase IIb study. Sagimet plans to initiate phase III program by end of 2024. Currently, Madrigal Pharmaceuticals' Rezdiffra is the only approved MASH treatment.

UAVS up 70% pre-market on $6.5M public offering, SLXN up 50% on SIL-204 preclinical breakthroughs, SGMT up 11% on FDA Breakthrough Therapy Designation for Denifanstat in MASH.

FDA grants Breakthrough Therapy Designation to Sagimet Biosciences’ denifanstat for treating noncirrhotic MASH with moderate to advanced fibrosis, based on phase 2b FASCINATE trial data showing significant improvements in MASH resolution and NAS reduction. Denifanstat, an oral FASN inhibitor, targets fat accumulation, inflammation, and fibrosis, positioning it as a potential leading treatment for MASH.

FDA grants Breakthrough Therapy designation to Sagimet Biosciences' denifanstat for MASH treatment, supported by positive Phase 2b FASCINATE-2 trial data. Phase 3 program planned by end of 2024.

Sagimet Biosciences' denifanstat receives FDA breakthrough therapy designation for treating noncirrhotic MASH with moderate to advanced liver fibrosis, based on Phase 2b FASCINATE-2 study results. A Phase 3 study is planned by end of 2024.