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pdufa.bio

Odronextamab

Updated ยทnext FDA decision on the calendar

Odronextamab is a Regeneron Pharmaceuticals Inc. program. Its next catalyst is a Readout in Jan 2027. Every date links its source.

REGN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Regeneron Pharmaceuticals Inc. (REGN). 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 2027REGN

Questions

When is Odronextamab's next FDA decision or readout?

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

What happened at Odronextamab's most recent FDA decision?

No FDA decision for Odronextamab is in our archive yet.

Who makes Odronextamab?

Regeneron Pharmaceuticals Inc. (REGN).

Where does this data come from?

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