French drugmaker Ipsen (Euronext: IPN) has had a busy Thursday - announcing an update on its overall outlook and elafibranor, a key pipeline prospect.
Regarding the latter, the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor, granting it priority review, with a target date for a decision of June 10, 2024.
The oral, once-daily dual peroxisome activated receptor alpha/delta agonist could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, primary biliary cholangitis (PBC), in nearly a decade.
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