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pdufa.bio

Mirikizumab

Updated ยทnext FDA decision on the calendar

Mirikizumab is a ELI LILLY & Co program. Its next catalyst is a Readout in Dec 2027. 2 FDA decisions on record below. Every date links its source.

LLY catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Mirikizumab is marketed as Omvoh (mirikizumab-mrkz); the events below include those tracked under the brand name. Sponsor: ELI LILLY & Co (LLY). We track 3 catalyst events for this program: 1 upcoming and 2 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

PDUFA · Jan 15, 2025 ✓ ApprovedLLYPDUFA · Oct 27, 2025 ✓ ApprovedLLYReadout · Dec 2027LLY

Questions

When is Mirikizumab's next FDA decision or readout?

The next tracked catalyst for Mirikizumab is a Readout in Dec 2027.

What happened at Mirikizumab's most recent FDA decision?

On Oct 27, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Mirikizumab?

ELI LILLY & Co (LLY).

Has Mirikizumab been approved by the FDA?

Yes. The FDA approved an application for Mirikizumab on Oct 27, 2025; the decision page linked above carries the source.

Where does this data come from?

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