Inventiva SA is getting $10 million up front and the possibility of $231 in clinical, regulatory and commercial milestones by exclusively licensing its nonalcoholic steatohepatitis (NASH) candidate, lanifibranor, to Hepalys Pharma Inc. to sell in Japan and South Korea, two massive markets for the indication.
Genflow Biosciences plc has received correspondence from Belgium’s Federal Agency for Medicines and Health Products (FAHMP) with a recommendation to initiate a phase I/II trial of GF-1002 in patients with nonalcoholic steatohepatitis (NASH), rather than in healthy volunteers.
Hepagene Therapeutics Inc. has received FDA clearance of its IND application for HPG-7233 for the treatment of patients with nonalcoholic steatohepatitis (NASH) and dyslipidemia.
In a potential breakthrough for diagnosis and treatment development of liver disease, the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project demonstrated that a blood test could diagnose nonalcoholic steatohepatitis (NASH), an increasingly common liver disease in the U.S. The study, published in Nature Medicine, identified four biomarkers that outperform current liquid biopsies for NASH.
Researchers from Guangdong Pharmaceutical University and affiliated organizations have discovered novel farnesoid X receptor (FXR) agonists as candidates for the treatment of nonalcoholic steatohepatitis (NASH).
Nonalcoholic steatohepatitis (NASH) is a progressive form of nonalcoholic fatty liver disease with limited treatment options that can progress to more severe forms of liver damage such as cirrhosis or hepatocellular carcinoma. Targeting peroxisome proliferator-activated receptors (PPARs) with compounds such as elafibranor (GFT-505) is a feasible strategy for the prevention and treatment of NASH.
Developers of medical technology have many concerns about the U.S. Centers for Medicare & Medicaid Services’ (CMS) handling of coverage and reimbursement, but those controversies have typically revolved around process. A new report sponsored by industry steers a somewhat different tack, however, arguing that while there are issues of process, one key issue is that of funding, a problem that only Congress can remedy.
Histoindex Pte Ltd.'s’s artificial intelligence (AI)-enabled tissue imaging technology more accurately measures the change in fibrosis than current pathology tests, the company said.
Terns Pharmaceuticals Inc.’s unveiled positive top-line data from the phase IIa Duet study testing TERN-501, an oral thyroid hormone receptor-beta (THR-B) agonist, given as a monotherapy or in combination with TERN-101, a liver-distributed farnesoid X receptor agonist, for the treatment of nonalcoholic steatohepatitis (NASH).
Two biopharma companies entered the public markets on July 14, with Apogee Therapeutics Inc. pricing a $300 million IPO, the second largest U.S. debut this year, and Sagimet Biosciences Inc. raising $85 million. Apogee, of San Francisco, and Waltham, Mass., is advancing APG-777 and APG-808, which are in development for atopic dermatitis (AD) and chronic obstructive pulmonary disease, while San Mateo, Calif.-based Sagimet’s lead candidate is the FASN inhibitor denifanstat for nonalcoholic steatohepatitis.
