In the wake of a selloff stoked by disappointing results for CymaBay’s (CBAY-45.4%) NASH candidate seladelpar, Genfit SA (GNFT -14.2%) has released a letter to investors aimed at clearing up any “confusion” with elafibranor. To wit:
FDA approval will be based on NASH resolution without worsening of fibrosis via histological examination (evaluating tissue samples with a microscope). By this definition, elafibranor was successful in a Phase 2b study. An ongoing Phase 3, RESOLVE-IT, has the same endpoint. Preliminary data should be available by year-end.
The reduction in liver fat content, the endpoint in CymaBay’s Phase 2b studythat caused the selloff, is not considered a relevant efficacy endpoint by regulators.
It has also shown beneficial effects on HbA1C, insulin sensitivity and “bad cholesterol.”
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