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pdufa.bio

Resmetirom

Updated ยทnext FDA decision on the calendar

Resmetirom is a Madrigal Pharmaceuticals, Inc. program. Its next catalyst is a Readout in Dec 2026. Every date links its source.

MDGL catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Madrigal Pharmaceuticals, Inc. (MDGL). We track 2 catalyst events for this program: 2 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

Readout · Dec 2026MDGLReadout · Mar 2027MDGL

Questions

When is Resmetirom's next FDA decision or readout?

The next tracked catalyst for Resmetirom is a Readout in Dec 2026.

What happened at Resmetirom's most recent FDA decision?

No FDA decision for Resmetirom is in our archive yet.

Who makes Resmetirom?

Madrigal Pharmaceuticals, Inc. (MDGL).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.