Liver disease remains the focus of Genfit, despite a high-profile clinical trial failure in the fatty liver disease NASH. The company is building out its pipeline by acquiring Versantis, a clinical-stage biotech whose most advanced drug candidate brings a novel approach to treating a deadly chronic liver disease complication that has no FDA-approved therapies.
The company said it was formally terminating the Phase III study of the drug elafibranor in NASH and refocus its development of the drug on another disease, primary biliary cholangitis, as well as a diagnostic for NASH.
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The French drugmaker said Monday that its Phase III study of elafibranor failed to meet its primary and key secondary endpoints. Analysts remarked that this extends the lead of the drug likely to get the first NASH approval, Intercept's obeticholic acid.
Shares of the French company fell more than 3% Friday following news it would delay unblinding data from the Phase III study of elafibranor. This marks the second delay of data since September and means it will likely be announced in the second quarter rather than the first.
In a note to investors, an analyst wrote that the news bodes well for the company's anticipated Phase III readout for the drug, elafibranor. Another company, Intercept Pharmaceuticals, said the FDA had accepted its application for its investigational NASH drug, obeticholic acid.
The French company, developing a drug to treat nonalcoholic steatohepatitis, or NASH, announced the pricing of its shares at $20.32 apiece.
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The company, one of several developing drugs for the growing fatty liver disease, said in an SEC filing that it would sell its shares at $26.33 apiece.