Madrigal Pharmaceuticals

Boehringer Ingelheim received FDA breakthrough therapy designation for survodutide, a dual GLP-1 and glucagon receptor agonist, for treating non-cirrhotic MASH and moderate or advanced fibrosis. The company initiated two Phase III trials, LIVERAGE and LIVERAGE-Cirrhosis, evaluating survodutide in MASH patients with moderate or advanced fibrosis and cirrhosis, respectively. The MASH market is projected to reach $25.7bn by 2032.

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.

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.

Rezdiffra improves emotional well-being and health distress in MASH/NASH patients, with positive tolerability.

Sonic Incytes received FDA 510(k) clearance for its Velacur Determined Fat Fraction (VDFF), a tool integrated into the Velacur device software designed to manage hepatic steatosis. VDFF correlates strongly with MRI-PDFF (0.85) and classifies patients with 95% accuracy for more than 5% MRI-PDFF, addressing the need for reliable non-invasive tests for metabolic dysfunction-associated steatotic liver disease (MASLD) impacting 100 million in the US.

Sonic Incytes announces FDA 510(k) clearance for Velacur® Determined Fat Fraction (VDFF), a tool estimating MRI-PDFF with 0.85 correlation and 95% accuracy, crucial for managing hepatic steatosis. VDFF addresses the need for reliable non-invasive tests, especially as metabolic dysfunction-associated steatotic liver disease (MASLD) affects millions in the US.

The FDA approved resmetirom, a drug for metabolic dysfunction-associated steatohepatitis (MASH), developed by Duke professor Paul Yen. Resmetirom targets MASH, a liver disease linked to obesity, affecting 115 million globally. Yen's research, focusing on thyroid hormones, led to the drug's development, aiming to prevent severe complications like cirrhosis and cardiovascular disease.