Intercept Pharmaceuticals, Inc.
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Latest From Intercept Pharmaceuticals, Inc.
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.
The liver disease is one of the hottest areas of drug development. Here are some upcoming catalysts to look out for.
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.
Seladelpar may threaten an entrenched second-line therapy, Intercept’s Ocaliva, with better efficacy, based on benefits demonstrated in the pivotal RESPONSE trial.
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