Madrigal and liver drug developers fall ahead of FDA decision on NASH therapy

Companies focused on developing drugs for a liver disease called nonalcoholic steatohepatitis (NASH) are among the notable decliners on Thursday as Wall Street waits for a potential FDA approval of resmetirom, Madrigal Pharmaceuticals' (NASDAQ:MDGL) lead asset targeted at NASH.

Madrigal (MDGL) has lost ~10%, marking its biggest intraday decline in more than a month on above-average volumes. More than 514.2K MDGL shares have changed hands compared to the 65-day average of ~480.8K.

Its rivals in NASH, including Viking Therapeutics (VKTX), Akero Therapeutics (AKRO), 89bio (ETNB), Enanta Pharma (ENTA), Sagimet Biosciences (SGMT), Galectin Therapeutics (GALT), Terns Pharma (TERN), and Arrowhead Pharma (ARWR), are also in the red.

All stocks except Arrowhead (ARWR) and Sagimet (SGMT) have recorded substantial gains this year amid the ongoing FDA review on resmetirom, a once-daily thyroid hormone receptor (THR)-β selective agonist.

In September, the regulator accepted Madrigal's (MDGL) marketing application for resmetirom for NASH with liver fibrosis, granting March 14 as the target action date.