Intent on expanding both the reach and approved uses of its farnesoid X receptor agonist, Ocaliva (obeticholic acid), Intercept Pharmaceuticals Inc. is selling both its ex-U.S. operations and rights to the primary biliary cholangitis drug to U.K.-based Advanz Pharma Corp. Ltd. for $405 million up front. The deal, including an additional $45 million earnout tied to EU regulatory advances, represents an important step toward strengthening Intercept's balance sheet and options, said CEO and President Jerry Durso.
With the rates of nonalcoholic steatohepatitis (NASH) rapidly rising, Glympse Bio Inc. and Laboratory Corp. of America Holdings Inc. (Labcorp) have announced new tests that can assess the risk of the liver condition without the traditional biopsy.
Merck & Co. Inc., building on a year-old deal with Aligos Therapeutics Inc., has moved to in-license an early stage nonalcoholic steatohepatitis (NASH) oligonucleotide program Aligos had previously advanced independently. The amended deal also gives Merck the right to add a new NASH target to the partnership, in addition to those already part of the agreement. With Aligos eligible to receive up to $460 million in development and commercialization milestones as well as tiered royalties on net sales per target, its rewards could reach $1.38 billion.
LONDON – Metabolic diseases specialist Northsea Therapeutics BV closed a $80 million series C to fund phase II development in two further indications, as it awaits the final results from the phase IIb trial of its lead product, icosabutate, in the treatment of nonalcoholic steatohepatitis (NASH), which are due at the start of 2023.
An international collaborative study led by Chinese researchers at Wuhan University is the first to have discovered a new small molecule, termed IMA-1, and shown it to be safe and effective for the treatment of nonalcoholic steatohepatitis (NASH) in mouse and macaque models.
Sonic Incytes Medical Corp. collected $7.3 million in a series A fundraising round to bring its liver-focused point-of-care ultrasound solution to commercialization. Nimbus Synergies led the round with participation from Nicola Wealth, Mint Venture Partners, Consortium Medteq, Wavemaker Three-Sixty Health, Gaingels, INP Capital and several angel investors. The round was oversubscribed by 150%. The hand-held Velacur system noninvasively quantifies liver volume, stiffness and attenuation, critical factors in diagnosing and monitoring liver disease in a process that takes about five minutes and can be performed in a physician’s office. The system received FDA clearance late last year.
Glaxosmithkline plc (GSK) tapped Arrowhead Pharmaceuticals Inc. for its foray into nonalcoholic steatohepatitis (NASH), as the pair signed an exclusive global licensing deal (excluding China) for GSK to develop and commercialize phase I/II-stage ARO-HSD, Arrowhead’s RNAi therapy targeting HSD17B13.
Metacrine Inc.’s departure, in the wake of mixed phase IIa results, from the fiercely competitive nonalcoholic steatohepatitis (NASH) space with farnesoid X receptor (FXR) agonist MET-642, put a serious dent in shares and brought implications for other players. The San Diego-based firm’s stock (NASDAQ:MTCR) closed at $1.63, down $2.20, or 57%, as its plans to shift emphasis from NASH to inflammatory bowel disease (IBD) were made known.
Shares of Cohbar Inc. (NASDAQ:CWBR) hit a 52-week high on Aug. 11 following news that a mitochondrial peptide analogue it is testing for the potential treatment of nonalcoholic steatohepatitis (NASH) and obesity, CB-4211, delivered "robust" improvements in key biomarkers of liver damage and glucose levels vs. placebo during a small phase Ia/Ib study.
All the primary endpoints were met in Hepion Pharmaceuticals Inc.’s phase IIa trial of CRV-431 for treating nonalcoholic steatohepatitis (NASH). The market, however, wasn’t celebrating as the Edison, N.J.-based company’s stock (NASDAQ:HEPA) sagged 15.27% on July 13 to close at $1.72 per share.
