Madrigal seeks accelerated approval for experimental NASH treatment a week after Intercept rejection

Madrigal Pharmaceuticals kicked off the regulatory review process for its experimental NASH treatment as it pursues the first FDA approval to treat the debilitating and sometimes fatal liver disease for which no other therapies exist.

Madrigal announced Friday that it began a rolling submission for accelerated approval of resmetirom as a treatment for NASH with liver fibrosis, based on data showing that the thyroid hormone beta-receptor agonist met both primary surrogate endpoints in a Phase III trial. The company said it submitted the majority of its NDA, and it plans to file the remaining components in July.

The company’s stock $MDGL was trading up more than 3% on Friday morning.

All eyes will be on resmetirom’s tolerability profile after safety concerns led to a second rejection of Intercept’s closely watched NASH hopeful obeticholic acid.

Intercept, which bowed out…
Click here to view original post