Intercept’s CRL Just Continues Upheaval In NASH
With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?
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The new analysis of REGENERATE, based on an FDA-requested methodology, shows continued efficacy for OCA, but analysts were circumspect about whether the benefit/risk profile would sway the agency.
Resmetirom, Madrigal’s THRβ agonist, demonstrates safety and tolerability, and succeeds on secondary efficacy endpoints in a study serving as a precursor to the firm’s pivotal Phase III trial.
Metacrine halts development of its FXR agonist compounds in NASH and turn its focus to inflammatory bowel disease. Firm plans Phase II ulcerative colitis study in 2022 with MET642.