CymaBay’s Stalled Seladelpar Back In Play For PBC
Weeks after lifting of an FDA clinical hold, CymaBay says it will resume development of its PPAR agonist in primary biliary cholangitis. It will initiate a new Phase III trial but also use data from a terminated Phase III study.
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With up to $100m from Abingworth and a recent $75m FOPO, CymaBay has runway to await pivotal data in primary biliary cholangitis in 2023 for seladelpar, after the candidate failed in NASH. It sees a significant market opportunity in the second-line setting cornered by Intercept.
Intercept and Axcella provide updated data on their NASH programs at the International Liver Conference, while CymaBay offers the full dataset for seladelpar in PBC.
A fuller look at interim Phase III data shows no path forward to accelerated approval in NASH, company says. Genfit turns focus to developing elafibranor for PBC, as well as a NASH diagnostic.