Jan. 31 Quick Takes: After top-line NASH data, Madrigal looks ahead to biopsy readout

Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) overcame its first randomized controlled Phase III hurdle for NASH candidate resmetirom with top-line data from the MAESTRO-NAFLD-1 study showing the thyroid hormone receptor beta-selective agonist was well tolerated and reduced liver fat, but the true test will come later this year when the serial biopsy study reads out. Across 943 evaluable patients treated with 80 or 100 mg doses of resmetirom, levels of liver fat measured by magnetic resonance imaging, proton density fat fraction (MRI-PDFF) was reduced by 43% and 48%, respectively, vs. placebo, and by 53% in an open-label 100 mg dose cohort. Madrigal shares rose $1.19 to $57.58 Monday.

FDA approved Spikevax COVID-19 vaccine mRNA to prevent the disease in individuals 18 years and older — the first-ever FDA approval for Moderna Inc. (NASDAQ:MRNA). The vaccine has been available in the U.S. under emergency use authorization since Dec. 18, 2020, and is approved by regulatory authorities in more than 70 countries. Spikevax’s use as a booster remains under EUA in the U.S. Shares of Moderna rose 6% to $169.33 on Monday...