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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While neither company reported new data from their ongoing trials at AASLD, the firm’s competing THRβ agonists are viewed as leading lights in the non-alcoholic steatohepatitis competition.
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.