After reviewing data from its phase II trial of farnesoid X receptor agonist ASC-42 in primary biliary cholangitis, Ascletis Pharma Inc. said it was quitting development of the molecule in all indications.
After reviewing data from its phase II trial of farnesoid X receptor agonist ASC-42 in primary biliary cholangitis, Ascletis Pharma Inc. said it was quitting development of the molecule in all indications.
Seeking to rejuvenate itself after recent disappointments, Gilead Sciences Inc. proposes to bolster its liver portfolio by taking over Cymabay Therapeutics Inc. for $32.50 per share in cash, a total equity value of $4.3 billion. The arrangement brings aboard seladelpar for second-line primary biliary cholangitis (PBC) including pruritis (itch), which is under priority review by the U.S. FDA, with a decision due this year.
Three months after Intercept Pharmaceuticals Inc. received its second complete response letter for obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis, causing a mass layoff and the decision to drop development for the indication, Bologna, Italy-based Alfasigma SpA agreed to acquire the company for $19 per share in cash, or about $793.8 million.
Positive phase III data from Cymabay Therapeutics Inc. with seladelpar, the peroxisome proliferator-activated receptor for primary biliary cholangitis (PBC), could mean trouble for Intercept Pharmaceuticals Inc.’s second-line therapy, the farnesoid X receptor agonist Ocaliva (obeticholic acid), which Cymabay aims to replace with its compound as the preferred choice.
Three years after stopping development in nonalcoholic steatohepatitis, Genfit SA and partner Ipsen Pharma SA have announced positive phase III data for elafibranor in the treatment of primary biliary cholangitis (PBC) and are preparing to file for U.S. FDA and EMA approval.
Intercept Pharmaceuticals Inc.’s second attempt to score an expanded U.S. FDA approval of its farnesoid X receptor agonist, obeticholic acid, in patients with non-alcoholic steatohepatitis (NASH) went the way of the first, with the agency issuing another complete response letter (CRL), prompting the company to drop all NASH-related investment and cut a third of its workforce.
Primary biliary cholangitis (PBC) is the most common autoimmune liver disease; several genome-wide association studies have suggested chromosome locus 19p13.3 is associated with PBC pathology. Chinese researchers conducted a case-control study to unveil genetic variants in the 19p13.3 locus associated with PBC. The meta-analysis included 1,931 individuals with PBC and 7,852 controls.
New research has identified a novel receptor that interacts with the angiotensin-converting enzyme 2 (ACE2) by which the SARS-CoV-2 enters host cells, and shown it can be inhibited with marketed drugs, reducing expression of ACE2 and blocking viral entry.
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.