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Ivonescimab

Updated ยทnext FDA decision on the calendar

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.

SMMT catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

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.

Catalyst history

Readout · Jul 2026SMMTPDUFA · Nov 14, 2026SMMTReadout · Dec 2026SMMTReadout · Apr 2027SMMTReadout · Jun 2027SMMTReadout · Aug 2027SMMTReadout · Sep 2027SMMTReadout · Dec 2027SMMT

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.
About · Corrections · Methodology

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