Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 9:00 PM ET
Ivonescimab is a Summit Therapeutics Inc. program. Its PDUFA date is Nov 14, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Sponsor: Summit Therapeutics Inc. (SMMT). Market-cap tier at the time we tracked it: Large. We track 8 catalyst events for this program: 7 upcoming and 1 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.
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
When is Ivonescimab's next FDA decision or readout?
Ivonescimab's PDUFA date is Nov 14, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Ivonescimab's most recent FDA decision?
No FDA decision for Ivonescimab is in our archive yet.
Who makes Ivonescimab?
Summit Therapeutics Inc. (SMMT).
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.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
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.