After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting accelerated approval of drugs for noncirrhotic nonalcoholic steatohepatitis.

Plus deals involving Astellas/Menarini, Maruho/Fortress Biotech, Zenas/Bristol Myers Squibb, Huadong Medicine/MC2 and more.

TERN-501 monotherapy looks serviceable in a mid-stage NASH trial, but others are ahead. Perhaps partnership is the way forward.