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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