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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.
NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval
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.
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