Genfit's Enrollment Delay In NASH May Aid Intercept's First-To-Market Goal
Firm cites heavy competition for NASH patients, as well as desire for balanced enrollment in elafibranor pivotal study. Competitor Intercept pushed back its Phase III enrollment timeline this past February.
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Genfit will delay unblinding of data from its nearly complete Phase III study of elafibranor to get insight from the FDA on statistical methods in order to optimize its NDA.
Yescarta continued its growth trajectory, the HIV franchise showed solid sales growth and the hepatitis C franchise stayed steady – plus Gilead could jump to the head of the line in NASH.
Company is moving its galectin-3 inhibitor into Phase III in non-alcoholic steatohepatitis patients with cirrhosis – a very advanced disease setting – and also to validate endpoints that don’t require liver biopsy.