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pdufa.bio

Setrusumab

Updated ยทnext FDA decision on the calendar

Setrusumab is a Ultragenyx Pharmaceutical Inc. program. Its next catalyst is a Readout in Jan 2027. Every date links its source.

RARE catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Ultragenyx Pharmaceutical Inc. (RARE). We track 1 catalyst event for this program: 1 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 · Jan 2027RARE

Questions

When is Setrusumab's next FDA decision or readout?

The next tracked catalyst for Setrusumab is a Readout in Jan 2027.

What happened at Setrusumab's most recent FDA decision?

No FDA decision for Setrusumab is in our archive yet.

Who makes Setrusumab?

Ultragenyx Pharmaceutical Inc. (RARE).

Where does this data come from?

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