Madri­gal says it's 'well on the way' to po­ten­tial NASH launch ahead of FDA de­ci­sion: #JPM24

SAN FRAN­CIS­CO — Madri­gal Phar­ma­ceu­ti­cals will be “ready to go” if the FDA grants its non­al­co­holic steato­hep­ati­tis hope­ful an ac­cel­er­at­ed ap­proval in March, the com­pa­ny’s new CEO Bill Si­bold said Wednes­day.

Resme­tirom would be the first ap­proved treat­ment in an area that’s seen fail­ure af­ter fail­ure, in­clud­ing In­ter­cept’s close­ly-watched FXR ag­o­nist obeti­cholic acid, which was re­ject­ed for a sec­ond time in June fol­low­ing safe­ty con­cerns. Madri­gal com­plet­ed its sub­mis­sion short­ly af­ter In­ter­cept’s CRL, though its can­di­date re­lies on a dif­fer­ent mech­a­nism of ac­tion known as thy­roid hor­mone be­ta-re­cep­tor ag­o­nism.

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