CymaBay Appears Stronger Threat To Ocaliva In PBC Than Ipsen/Genfit
CymaBay and Genfit have been positioning their failed NASH candidates, both PPAR agonists, for approval in second-line primary biliary cholangitis. Analysts call both approvable, but say CymaBay’s drug has a better overall profile.
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Adding to its liver disease portfolio, Gilead agreed to pay a 27% premium for CymaBay and seladelpar, which has a 14 August FDA action date to compete in second-line primary biliary cholangitis.
The FDA is set to make a decision on elafibranor for primary biliary cholangitis by June next year, which could give Ipsen a head start over CymaBay's seladelpar.
The Bologna-based firm is looking to grow its presence in the US as well as in gastrointestinal and liver disease as it acquires Intercept, which received a second rejection for its NASH drug OCA in June.