Upcoming FDA decision · November 30, 2026
Drug: Ivonescimab Injection PDUFA date: FDA decision expected November 30, 2026
108 days to goSummit Therapeutics Inc. (SMMT) →
The FDA is expected to decide on Drug: Ivonescimab Injection from Summit Therapeutics Inc. in Metastatic Colorectal Cancer (CRC) by the PDUFA target action date of November 30, 2026. bla filing. AI-extracted from news: Summit outlines November 14 FDA PDUFA date for ivonescimab BLA while planning HARMONi-3 PFS in 2H 20
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.
November 30
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations