Tag Archive for: liver disease

The drug was approved under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. 

Gilead Sciences announced Monday it is acquiring CymaBay Therapeutics and its lead candidate seladelpar, an investigational treatment for primary biliary cholangitis, in a $4.3 billion deal.

The Danish drugmaker said the partnerships with Omega Therapeutics and Cellarity Inc. could lead to new treatments for people living with obesity and a type of liver disease known as MASH.

In a late-stage trial, treatment with Ipsen and Genfit’s elafibranor led to high rates of biochemical response and the normalization of alkaline phosphatase levels compared with placebo.

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.

In Genethon’s Thursday announcement, the company claimed the results are the first clinical demonstration of the efficacy of gene therapy in a metabolic disease of the liver.

The deal gives Moderna access to Generation Bio’s proprietary drug delivery system and DNA technology to develop drugs targeting immune cells and the liver.

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.

GSK is planning a Phase III trial evaluating bepirovirsen as a potential functional cure for chronic hepatitis B infection, despite the most recently released data appearing less robust than the interim analyses. The trial is expected to begin in the first half of 2023.

Intercept Pharmaceuticals Inc. said on Friday its treatment for patients with advanced liver scarring due to non-alcoholic steatohepatitis (NASH) failed to meet the main goal of a late-stage study, sending its shares down as much as 21%.