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.
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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.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.