Genfit Dives Into Uncertain Late-stage NASH Trial
This article was originally published in Scrip
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A complete response letter from the FDA knocked Intercept’s stock price for six, but perhaps the FDA is sending wider messages about NASH.
Genfit SA is now pinning its hopes for elafibranor on primary biliary cholangitis after the dual PPAR alpha/delta agonist failed in its Phase III RESOLVE-IT trial for NASH.
Liver health key opinion leaders say pre-authorization, requirements for biopsies or sicker patients could limit early uptake of NASH drugs. Intercept’s OCA, Genfit’s elafibranor both seen as likely combo therapy components.