Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint
Executive Summary
Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.
You may also be interested in...
Stock Watch: Tales Of Stock Price Overreactions
Two clinical trial announcements in the same NASH indication separated by almost nine years had very similar stock price reactions despite the known unknowns of NASH remaining unknown.
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: Pfizer takes on AstraZeneca and Merck & Co in prostate cancer; AstraZeneca’s gene therapy acquisition; ex-Sanofi partnering head joins AI start-up; Shionogi and Medicines Patent Pool strike deal for oral COVID antiviral; and Intercept sticks with NASH plans despite missed endpoint.
Intercept Commits To Resubmitting NASH NDA, But Analysts See Conflicting Signs
CEO Durso says Intercept is aiming to refile its NDA by end of 2021, but several departures in recent months indicate pessimism on NASH prospects to some analysts.