Tag Archive for: non-alcoholic steatohepatitis (NASH)

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. 

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.

Altimmune released mid-stage data Tuesday showing pemvidutide helped reduce patients’ weight by 10%, but the company’s shares tumbled 55% over safety concerns with the obesity drug.

J&J’s Janssen Pharmaceutical has given up on an RNAi therapeutic being developed for one of biotech’s hottest targets: non-alcoholic steatohepatitis (NASH). 

2022 featured pivotal data that could change the landscape in non-alcoholic steatohepatitis, Alzheimer’s disease, sickle cell disease and many more indications.

CytoDyn withdrew its pending Biologics License Application for the monoclonal antibody in HIV Friday, citing concerns involving the contract research organization managing its trials.  

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%.

Shares of Angion Biomedica Corp. are falling fast after the company announced it had discontinued a mid-stage study of an oral tyrone kinase inhibitor in patients with primary proteinuric kidney diseases due to safety reasons. And Novo Nordisk also hit a wall, reporting that its diabetes drug Ozempic (semaglutide) failed to inprove liver fibrosis in NASH-related cirrhosis.

On Thursday, Pfizer announced the U.S. Food and Drug Administration granted the company’s combinatorial therapeutic ervogastat/clesacostat Fast Track Designation. The therapeutic combo is intended for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis.