Upcoming FDA decision · November 14, 2026
Ivonescimab Injection PDUFA date: FDA decision expected November 14, 2026
29 days to goSummit Therapeutics Inc. (SMMT) →
The FDA is expected to decide on Ivonescimab Injection from Summit Therapeutics Inc. in EGFR-mutated non-squamous NSCLC after prior EGFR TKI therapy by the PDUFA target action date of November 14, 2026. For EGFR-mutated non-squamous NSCLC after prior EGFR TKI therapy. BLA (with chemotherapy). Verified against the company announcement on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 14
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Ivonescimab Injection?
- The FDA's PDUFA target action date for Ivonescimab Injection is November 14, 2026. The FDA can act before that date, and the review can be extended.
- What is Ivonescimab Injection being reviewed for?
- The application under FDA review covers EGFR-mutated non-squamous NSCLC after prior EGFR TKI therapy.
- Which company is developing Ivonescimab Injection?
- Summit Therapeutics Inc. (SMMT).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).