Denifanstat

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.

FDA grants Breakthrough Therapy designation to Sagimet Biosciences' denifanstat for treating noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis, based on positive Phase 2b FASCINATE-2 trial results. Denifanstat showed significant improvements in MASH resolution and fibrosis reduction, with generally well-tolerated safety profile. Phase 3 program planned by end of 2024.