With this deal, expected to close by the end of the year, Alfasigma aims to expand its treatment portfolio related to liver diseases and digestive system disorders.
Tag Archive for: Intercept Pharmaceuticals
Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space
Thursday, the FDA denied Intercept Pharmaceuticals’ application for its obeticholic acid tablets, which the New Jersey biopharma was proposing to treat patients with pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis.
Shares of Intercept Pharmaceuticals fell 16% on Monday over concerns about the prospects of the company’s drug to treat a type of fatty liver disease after the regulator’s advisory panel voted to defer an accelerated approval.
The agency’s briefing documents highlighted increased risk of diabetes and liver injury from using the obeticholic acid oral tablets for treatment of nonalcoholic steatohepatitis.
Viking Therapeutics Inc said on Tuesday its experimental drug met the main goal of a mid-stage trial to treat patients with a type of fatty liver disease, sending its shares about 6% higher in early trade.
As a result of the industry’s steady progress in the clinic, coupled with the enormous commercial opportunity inherent in NASH, NASH stocks soared over the course of 2014 to 2018. Then, the bottom fell out.
Akero Therapeutics Inc. said on Tuesday its lead experimental drug met the main goal for treatment of a type of fatty liver disease, sending the company’s shares soaring more than 60% in premarket trading.
Intercept Pharmaceuticals said it would resubmit its application for nonalcoholic steatohepatitis (NASH) treatment to the U.S. Food and Drug Administration based on new interim analysis of data from an ongoing late-stage study. The company is seeking approval for obeticholic acid to treat fibrosis or scarring associated with NASH, a serious progressive liver disease caused by excessive fat accumulation in the liver.