Intercept Makes No Changes To Ocaliva NASH Study Despite PBC Safety Issues
Data monitoring safety board okays continuation of pivotal REGENERATE study in non-alcoholic steatohepatitis despite deaths of patients receiving Ocaliva for primary biliary cholangitis.
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Life After NASH For CymaBay: An Interview With CEO Sujal Shah
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.
Genfit Thinks Intercept’s Lead In NASH Not As Wide As Perceived
Genfit believes elafibranor’s clean tolerability and safety profile may help narrow the gap between it and Intercept’s OCA, with safety questions delaying OCA’s entry to market. Part two of Scrip’s interview with Genfit’s CEO and COO.
CymaBay Following The Leaders, Pursues NASH, PBC Simultaneously
Biotech thinks its PPAR delta agonist will prove much more potent than Genfit’s elafibranor from the same class and will offer a better tolerability profile than Intercept’s OCA.