Genfit delays high-stakes PhIII NASH readout; Bristol-Myers grabs first Opdivo OK in esophageal cancer
→ Genfit is delaying a highly anticipated Phase III readout of its NASH drug elafibranor. It now expects to report topline interim results some time in the second quarter, after incorporating new “FDA insights” to be delivered by the end of March. The French biotech insists that the delay — which is technically a delay in unblinding — isn’t related to efficacy and safety concerns or any business matters. The stakes are high: The RESOLVE-IT trial was set up to be a crucial test of the PPAR approach in tackling the fatty liver disease and support a historic accelerated approval.
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