SFA Therapeutics Inc. has received FDA clearance of its IND application to investigate SFA-001N in patients with nonalcoholic steatohepatitis (NASH) with or without fibrosis.

Phathom Pharmaceuticals Inc.’s shares sank 31% on news that the U.S. FDA will not take action on the company’s NDA for oral small-molecule potassium-competitive acid blocker vonoprazan by the Jan. 11 PDUFA date.

Alagille syndrome (ALGS) is a rare JAG1 (encodes for a Notch ligand) autosomal dominant disease affecting approximately 1 in 30,000-40,000 individuals. ALGS developmental defects cause an absence of bile ducts (intrahepatic duct paucity, IHDP) with an inability to transport bile from the liver to bile ducts (cholestasis) as well as heart problems.

Obesity and chronic inflammation in the liver trigger the most severe form of nonalcoholic fatty liver disease (NAFLD), steatohepatitis. Scientists at the University of Texas (UT) have shown how damaged hepatocytes accumulated in the liver after a vicious cycle of cytokine expression induced shedding of a critical liver receptor.

Benevolentai Ltd. has submitted a clinical trial application (CTA) to the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) for BEN-8744, an oral, peripherally restricted, small-molecule phosphodiesterase 10 (PDE10) inhibitor in development as a first-in-class treatment for ulcerative colitis.